Body of the project

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1.1 INTRODUCTION OF ORGANIZATIONAL STUDY

I underwent an organizational study at Cipla for a period of 4 weeks starting from the

month of August 2014, as a part of the MBA curriculum at the Bangalore University.

This study was conducted to understand the structure, function and processes of

various departments and their inter-dependence. During the course of study I was able

to successfully interact with the employees of the organization and they were happy to

give me all the possible information regarding the company. They also took me to the

manufacturing units where I got the first hand information about the organizational

processes and its functions.

The Research Methodology consists of data collection through interview, observation,

internet search and company periodicals review. The data collected from different

sources are classified, analysed and interpreted. Based on which an organizational

structure, its functions and various departments are identified. The various

departmental functions are clearly identified and their processes & activities carried

out are recorded. An in-depth analysis is made me to understand the departmental

process based on which a process chart is prepared. The analysis further formed the

basis for identifying the departmental interdependence.

1.2 OBJECTIVES OF THE STUDY

The main objective is to make an in-depth study on the overall functioning of the

organization.

To get a clear idea about the organization design, service provided and trading.

To make a detailed study about functioning of various departments duties of

officials and different levels in the hierarchy.

To gain a practical knowledge and to have an exposure to the work environment.

To understand various policies, procedures and strategies.

GARDEN CITY COLLEGE OF SCIENCE AND MANAGEMENT STUDIES Page 1

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1.3 SCOPE OF THE STUDY

The study is being conducted for Cipla and this study tells us an overall view of the

organization and functions carried out by different departments like Production,

Packing, Stores, Quality Control, Quality Assurance, Human Resource and Corporate

Social Responsibility. Hence this study provides a wide scope to gain an insight into

the practice aspects of the working of an organization and thus increases managerial

skills.

1.4 LIMITATIONS OF THE STUDY

Critical analysis is not possible because of non-availability of required

information.

Lack of co-operation from certain departments due to their work load.

Interpretation of study is based on the respondent’s information.

The primary information obtained from officials is confidential in nature of

certain aspects.

Time to study some of the departments was limited.

1.5 METHODOLOGY OF THE STUDY

1.5.1 Primary Source of Data

Primary data are those collected by the investigator herself for the first time and thus

they are original in character.

1.5.2 Secondary Source of Data

Secondary data are those, which have already been collected by some other persons

for their purpose and published. Secondary data are usually in the shape of finished

products.

Two types of secondary data were collected for the preparation of the project work:


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Internal Data was generated from company’s brochures, manuals and annual

reports.

External Data, on the other hand, was generated from magazines, research

books and internet (websites).

1.5.3 Instrumentation Techniques

Primary Data

o Personal Interview

Personal interview method was applied to collect the actual data for the

research study. I met the HR and the various department heads at the

organization and collected all the necessary information from them.

Secondary Data

o Company Records

Company records like annual reports, brochures, manuals etc. has given

valuable information for the present study.

o Internet

Company related and topic related websites also provided significant

contribution in data collection.


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2.1 INDUSTRY PROFILE

India’s pharmaceutical sector has seen unwavering growth in the past few years,

going up to 23 billion USD in 2012 from 23 billion USD in 2002. Various industry

reports suggest that the pharmaceutical sector in India has been growing consistently

at the rate of 13-14 % every year since the last five years. According to the consulting

firm McKinsey & Company, India’s pharmaceutical sector will touch 55 billion USD

by 2020 and generics are expected to continue to dominate the market while patent-

protected products are likely to constitute 10 per cent of the market till 2015.

Indian pharmaceutical industry companies can broadly be classified as domestic

companies and foreign companies (MNCs). Some of the major players include

GlaxoSmithKline, Cipla, Dr. Reddy’s Laboratories, Ranbaxy, Pfizer etc. Financial

year 2013 was challenging on the domestic front and witnessed sluggish growth

owing to acute competition from unlisted players and so on. Growth in the sector is

expected to be boosted this year due to increasing consumer spending, rapid

urbanization.

There has been a paradigm shift in the attitude of people in India towards healthcare.

Alarming rise in cases of cardiovascular problems, nervous system disorders, diabetes

and many other diseases as well as disorders has created more awareness in the

growing population about the need of improvement in medical sector. Therefore,

there is a great need for pharmaceutical companies to invest their time and resources

in research and development of new, efficient and cost effective drugs.

India has an organized pharmaceutical market of its own, which is being considered

as a potential partner by other countries. The Indian Pharma Market is ranked number

3 in terms of volume and 10th in terms of market value. Indian pharma companies are

also proving to be global leaders in production of generics and vaccines.

According to a report by the Department of Industrial Policy and Promotion (DIPP),

India has attracted Direct Foreign Investment of US$ 11,391.03 million from April

2000-2013 and will see an upsurge in the years to come. Biopharmaceuticals is also


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increasingly becoming an area of interest given the complexity in manufacture and

limited competition.

According to a report by IMS Health, the domestic pharmaceutical market has seen a

growth of 13.5 % and recorded total sales of Rs 6,883 crore (US$ 1.12 billion) in the

month of July 2013. The major reasons for this growth can be attributed to continual

growth in prolonged therapies, increasing sales of generic medicines and

strengthening hold over rural markets.

From a market size of US$ 12.6 billion in 2009, the Indian pharmaceutical market

will grow to US$ 55 billion by 2020, with the potential to reach US$ 70 billion in an

aggressive growth scenario. In a pessimistic scenario characterised by regulatory

controls and economic slowdown, the market will be depressed but is still expected to

reach US$ 35 billion.

India currently exports drug intermediates, Active Pharmaceutical Ingredients (APIs),

Finished Dosage Formulations (FDFs), Bio-Pharmaceuticals, and Clinical Services

across the globe. The exports of pharmaceuticals from India grew to US$ 14.6 billion

in 2012-13 from US$ 6.23 billion in 2006-07, registering a compound annual growth

rate (CAGR) of around 15.2 per cent.

Among the top pharma companies, Abbott with total sales of Rs 452 crore (US$ 74.76

million), Cipla with Rs 322 crore (US$ 53.26 million), Sun Pharma with Rs 313 crore

(US$ 51.77 million), and Zydus Cadila with Rs 268 crore (US$ 44.32 million) were

the fastest growing companies in the month of September 2013. In terms of growth,

Sun Pharma (17.8 per cent) is ahead of peers such as Cadila (1.8 per cent), Cipla (0.8

per cent) and McLeod (0.7 per cent).

2.1.1 Investments

The allowance of foreign direct investment (FDI) in India's pharma sector has been

well received by foreign investors. According to data released by the Department of

Industrial Policy and Promotion (DIPP), the drugs and pharmaceutical sector attracted

FDI worth Rs 60,100.91 crore (US$ 9.94 billion) between April 2000 and June 2014.


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Some of the major investments in the Indian pharmaceutical sector are as follows:

Cipla has planned to invest £ 100 million (US$ 165.74 million) in its British

subsidiary. This investment will fund the launch of a range of drugs in the areas of

respiratory, oncology and antiretroviral medicines, as well as research and

development (R&D), clinical trials and further expansion internationally and in the

UK.

GeneOmbio Technologies and Resilient Cosmeceuticals have launched the country's

first comprehensive nutrigenomics support lab in collaboration with DNA LIFE under

the GeneSupport brand.

Cipla announced its fifth global acquisition deal, within a span of a year, by picking

up a 51 per cent stake for US$ 21 million in a pharmaceuticals manufacturing and

distribution business in Yemen.

Meiji Holdings has acquired Medreich for Rs 1,720 crore (US$ 284.51 million).

Temasek had earlier in 2005 invested Rs 109 crore (US$ 18.03 million) for a 25 per

cent stake in Medreich, which manufactures therapeutic generic and branded drugs.

Glenmark Pharmaceuticals has opened its new monoclonal antibody manufacturing

facility in La Chaux-de-Fonds, Switzerland. The facility supplements Glenmark's

existing in-house discovery and development capabilities and will supply material for

clinical development.

Arvind Remedies has obtained the rights from SRM University to access patented

technology for the commercial manufacture of drugs to combat Type II diabetes and

cardiovascular diseases.

2.1.2 Government Initiatives

As per extant policy, FDI up to 100 per cent, under the automatic route, is permitted

in the pharmaceutical sector for Greenfield investment. Hundred per cent FDI is also

permitted for investments in existing companies under the government approval route.


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Further, the Government of India has also put in place mechanisms such as the Drug

Price Control Order and the National Pharmaceutical Pricing Authority to address the

issue of affordability and availability of medicines.

Some of the major initiatives taken by the government to promote the pharmaceutical

sector in India are as follows:

India plans to set up industrial parks in the pharmaceutical and information

technology (IT) sectors in China to strengthen India-China trade and investment ties.

The Union Cabinet of India has cleared foreign investment proposal worth US$ 400

million by KKR to acquire stakes in two pharmaceutical companies, Gland Pharma

and Gland Celsus Bio Chemicals.

Mr Ghulam Nabi Azad, Union Minister for Health and Family Welfare, Government

of India, met Ms Margaret Hamburg, MD, Commissioner of Food and Drugs, USA. A

Statement of Intent on cooperation in the field of medical products was signed

between the US Food and Drugs Administration (USFDA) and the Ministry of Health

and Family Welfare, India.

The Pharmaceutical industry in India is the world's third-largest in terms of volume.

According to Department of Pharmaceuticals of the Indian Ministry of Chemicals and

Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and

September 2009 was US$21.04 billion. While the domestic market was worth

US$12.26 billion.The industry holds a market share of $14 billion in the United

States.

According to India Brand Equity Foundation, the Indian pharmaceutical market is

likely to grow at a compound annual growth rate (CAGR) of 14-17 per cent in

between 2012-16.India is now among the top five pharmaceutical emerging markets

of the world.

Exports of pharmaceuticals products from India increased from US$6.23 billion in

2006–07 to US$8.7 billion in 2008–09 a combined annual growth rate of

21.25%. According to Price Waterhouse Coopers (PWC) in 2010, India joined among


http://en.wikipedia.org/wiki/PricewaterhouseCoopers

http://en.wikipedia.org/wiki/Compound_annual_growth_rate

http://en.wikipedia.org/wiki/India_Brand_Equity_Foundation

http://en.wikipedia.org/wiki/United_States

http://en.wikipedia.org/wiki/United_States

http://en.wikipedia.org/wiki/Ministry_of_Chemicals_and_Fertilizers_(India)

http://en.wikipedia.org/wiki/Ministry_of_Chemicals_and_Fertilizers_(India)

http://en.wikipedia.org/wiki/Pharmaceutical_industry

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the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with

value reaching US$50 billion.

The government started to encourage the growth of drug manufacturing by Indian

companies in the early 1960s, and with the Patents Act in 1970. However, economic

liberalization in 90s by the former Prime Minister P.V. Narasimha Rao and the then

Finance Minister, Dr. Manmohan Singh enabled the industry to become what it is

today. This patent act removed composition patents from food and drugs, and though

it kept process patents, these were shortened to a period of five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational

companies that had dominated the market, and while they streamed out. Indian

companies carved a niche in both the Indian and world markets with their expertise in

reverse-engineering new processes for manufacturing drugs at low costs. Although

some of the larger companies have taken baby steps towards drug innovation, the

industry as a whole has been following this business model until the present.

India's biopharmaceutical industry clocked a 17 percent growth with revenues of Rs.

137 billion ($3 billion) in the 2009–10 financial year over the previous fiscal. Bio-

pharma was the biggest contributor generating 60 percent of the industry's growth at

Rs. 88.29 billion, followed by bio-services at Rs. 26.39 billion and bio-agri at Rs.

19.36 billion.

In 2013, there were 4,655 pharmaceutical manufacturing plants in all of India,

employing over 345 thousand workers.

2.2 History

The number of purely Indian Pharma companies is fairly less. Indian Pharma industry

is mainly operated as well as controlled by dominant foreign companies having

subsidiaries in India due to availability of cheap labour in India at lowest cost. In

2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of

formulations and bulk drugs. 85% of these formulations were sold in India while over

60% of the bulk drugs were exported, mostly to the United States and Russia. Most of

the players in the market are small-to-medium enterprises; 250 of the largest


http://en.wikipedia.org/wiki/Biopharmaceutical

http://en.wikipedia.org/wiki/Dr._Manmohan_Singh

http://en.wikipedia.org/wiki/P.V._Narasimha_Rao

http://en.wikipedia.org/wiki/Government_of_India

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companies control 70% of the Indian market. Thanks to the 1970 Patent Act,

multinationals represent only 35% of the market, down from 70% thirty years ago.

Most pharmaceutical companies operating in India, even the multinationals, employ

Indians almost exclusively from the lowest ranks to high level management. Home

grown pharmaceuticals, like many other businesses in India, are often a mix of public

and private enterprise.

In terms of the global market, India currently holds a modest 1–2% share, but it has

been growing at approximately 10% per year. India gained its foothold on the global

scene with its innovatively engineered generic drugs and active pharmaceutical

ingredients (API), and it is now seeking to become a major player in outsourced

clinical research as well as contract manufacturing and research. There are 74 US

FDA-approved manufacturing facilities in India, more than in any other country

outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications

(ANDA) to the FDA are expected to be filed by Indian companies. Growths in other

fields notwithstanding, generics are still a large part of the picture. London research

company Global Insight estimates that India’s share of the global generics market will

have risen from 4% to 33% by 2007. The Indian pharmaceutical industry has become

the third largest producer in the world and is poised to grow into an industry of $20

billion in 2015 from the current turnover of $12 billion.

2.2.1 Patent protection

As it expands its core business, the industry is being forced to adapt its business

model to recent changes in the operating environment. The first and most significant

change was the 1 January 2005 enactment of an amendment to India’s patent law that

reinstated product patents for the first time since 1972. The legislation took effect on

the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights

(TRIPS) agreement, which mandated patent protection on both products and

processes for a period of 20 years. Under this new law, India will be forced to

recognise not only new patents but also any patents filed after 1 January 1995. Indian

companies achieved their status in the domestic market by breaking these product


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patents, and it is estimated that within the next few years, they will lose $650 million

of the local generics market to patent-holders.

In the domestic market, this new patent legislation has resulted in fairly clear

segmentation. The multinationals narrowed their focus onto high-end patients who

make up only 12% of the market, taking advantage of their newly bestowed patent

protection. Meanwhile, Indian firms have chosen to take their existing product

portfolios and target semi-urban and rural populations.

2.3 Product development

Indian companies are also starting to adapt their product development processes to the

new environment. For years, firms have made their ways into the global market by

researching generic competitors to patented drugs and following up with litigation to

challenge the patent. This approach remains untouched by the new patent regime and

looks to increase in the future. However, those that can afford it have set their sights

on an even higher goal: new molecule discovery. Although the initial investment is

huge, companies are lured by the promise of hefty profit margins and has a legitimate

competitor in the global industry. Local firms have slowly been investing more

money into their R&D programs or have formed alliances to tap into these

opportunities.

2.3.1 Small and medium enterprises

As promising as the future is for a whole, the outlook for small and medium

enterprises (SME) is not as bright. The excise structure changed so that companies

now have to pay a 16% tax on the maximum retail price (MRP) of their products, as

opposed to on the ex-factory price. Consequently, larger companies are cutting back

on outsourcing and what business is left is shifting to companies with facilities in the

four tax-free states – Himachal Pradesh, Jammu & Kashmir, Uttaranchal and

Jharkhand. Consequently a large number of pharmaceutical manufacturers shifted

their plant to these states, as it became almost impossible to continue operating in

non-tax free zones. But in a matter of a couple of years the excise duty was revised on

two occasions, first it was reduced to 8% and then to 4%. As a result the benefits of


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shifting to a tax free zone was cancelled. This resulted in, factories in the tax free

zones, to start up third party manufacturing. Under this these factories produced goods

under the brand names of other parties on job work basis.

As SMEs wrestled with the tax structure, they were also scrambling to meet the 1 July

deadline for compliance with the revised Schedule M Good Manufacturing Practices

(GMP). While this should be beneficial to consumers and the industry at large, SMEs

have been finding it difficult to find the funds to upgrade their manufacturing plants,

resulting in the closure of many facilities. Others invested the money to bring their

facilities to compliance, but these operations were located in non-tax-free states,

making it difficult to compete in the wake of the new excise tax.

2.4 Employment Trends

With the expected growth rate of 14% per annum, Indian Pharmaceutical sector is

expected to create more jobs in India in 2014 and add 45,000 fresh openings to its

current strength. Not marred by recession or inflation, the pharma sector has a

competitive advantage of prospering steadily and thus attracts lots of young

professionals looking at pharmaceutical as their prospective career option. This sector

has also been responsible in creating a rich talent pool of researchers, scientists,

doctors and project managers.

The need of skilled manpower in the pharmaceutical industry ranges widely from

R&D, Quality Assurance (QA), Intellectual Property (IP), manufacturing to even

sales and marketing. What the pharma industry needs is to have better policies to

retain and nurture the existing talent and equip them with necessary skills. However,

this sector is emerging as a popular choice amongst Gen Y, since the nature of work,

primarily treating patients and research for new drug discoveries plays an integral role

in meeting their key career aspirations.


[Type a quote from the document or the summary of an interesting point. You can position

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2.5 Competitors

Sun Pharma were initially limited to 2 states - West Bengal and Bihar. Sales were

rolled out nationally in 1985. Products that are used in cardiology were introduced in

1987, and Monotrate, one of the first products launched at that time has since become

one of our largest selling products. Important products in Cardiology were then

added; several of these were introduced for the first time in India. Sun Pharma was

listed on the main stock exchanges in India in 1994.

It is an international speciality pharma company, with a presence in 30 markets. It

also make active pharmaceutical ingredients. In branded markets, its products are

prescribed in chronic therapy areas like cardiology, psychiatry, neurology,

gastroenterology, diabetology and respiratory. Realizing the fact that research is a

critical growth driver, they established their research center SPARC in 1993 and this

created a base of strong product and process development skills. In India, it has

reached leadership in each of the therapy areas that we operate in, and are rated

among the leading companies by key customers. Strengthening market share and

keeping this customer focus remains a high priority area for the company.

Another API plant, its Ahmednagar plant, was acquired from the multinational Knoll

Pharmaceuticals in 1996, and upgraded for approvals from regulated markets, with

substantial capacity addition over the years. This was the first of several sensibly

priced acquisitions, each of which would bring important parts to the long-term

strategy.

With world class technology and a team of strong professionals, it has built sites and

systems that meet the most stringent international manufacturing standards. Expert

quality teams ensure that systems and processes remain in compliance with the latest

standards.

A number of its plants hold approvals from the USFDA and the UK MHRA. APIs and

Dosage forms are made in 19 sites across India, US, Hungary and Bangladesh.


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Dr Reddy's Laboratories is a 25-year old company catering to the needs of the

pharmaceutical sector. Dr Reddy's started its operation in 1984 in the Active

Pharmaceutical Ingredients (API) segment, with a single drug in 60 tonne facility near

Hyderabad. In 1986 its shipped its first consignment of Methyldopa drug to West

Germany.

It is among the top three API players in world. Dr Reddy's, a global pharmaceutical

company, has its headquarters located in India. It has a global presence in more than

100 countries, with subsidiaries in the US, UK, Russia, Germany and Brazil; joint

ventures in China, South Africa and Australia; representative offices in 16 countries

and third-party distribution set ups in 21 countries.

It is first pharmaceutical company in Asia, outside Japan, to be listed on the NYSE. It

is largest player in the custom pharmaceutical services (CPS) business in India.The

pharma major has launched brands like Ciprolet, Nise, Enam, Stamlo, Omez, and

Ketorol among others.

Dr Reddy’s Laboratories launched Imitrex (sumatriptan succinate) tablets in dosages

of 25mg, 50mg, and 100mg in the US. It is the authorized generic version of

GlaxoSmithKline’s Imitrex. It is first company to launch Imitrex (generic version) in

the US market. These tablets are for treatment of acute treatment of migraine in

adults.

The company is having

6 FDA-inspected plants in INDIA

1 Cytotoxic facility

1 FDA-inspected plant in Mexico

1 FDA-inspected plant in Mirfield, UK

3 Technology development centers

(2 in Hyderabad, INDIA; 1 in Cambridge, UK)


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Cadila Healthcare (CHL), incorporated in 1995, is part of the Zydus Cadila Group.

The company operates in areas of active pharmaceutical ingredients (API) to

formulations, and animal health products to cosmeceuticals. Cadila Pharmaceuticals

Ltd. is one of the largest privately held pharmaceutical companies in India,

headquartered at Ahmedabad, in the state of Gujarat. Over the last five decades, it has

been developing and manufacturing pharmaceutical products and selling and

distributing these in over 50 countries around the world. An integrated healthcare

solutions provider with pharmaceutical product basket, it caters to over 45 therapeutic

areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-

infectives and antibiotics, respiratory agents, antidiabetics and immunologicals. The

company focuses on providing high quality, appropriately priced products to its

customers and supports all these with dedicated customer service. Cadila

Pharmaceuticals has a multicultural, multilingual and multinational workforce of

more than four thousand employees including over two hundred people outside India

in forty-nine countries of Africa, CIS, Japan and USA.

The company’s headquarter is located at Ahmedabad. CHL operates eight

manufacturing facilities out of which four formulation plants are located at

Ahmedabad, Goa, Baddi and Sikkim. The company has state-of-the-art manufacturing

facilities conforming to the most stringent international cGMP norms vis-à-vis WHO-

GMP, WHO, Geneva (GDF site for Anti- TB), TGA Australia (PIC/S), USFDA, UK-

MHRA, MCC-South Africa, ISO 9001 and ISO 14001. Spread over hundred acres of

land, Cadila Pharmaceuticals’ manufacturing facility at Dholka is the cynosure of all

eyes, well equipped with world-class production facilities. The company’s two Active

Pharmaceutical Ingredients units at Ankleshwar manufacture a wide-range of APIs

and intermediates including three USFDA certified products. The manufacturing

facility at Samba, near Jammu, started its commercial operations in August 2006. The

first overseas formulation manufacturing facility of Cadila Pharmaceuticals Ltd. has

commenced its operations in Ethiopia.

The Zydus Cadila Group operates in four continents spread across USA, Europe,

Japan, Brazil, South Africa and 25 other emerging markets.


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Sun PharmaDr. Reddy'sLab

Cadila HealthcareCipla

00.5

11.5

22.5

33.5

4

Ranking of the companies

Rank

Figure 2.5.1 Ranking of the companies

Sun Pharma

Dr. Reddy'sLab

Cadila Healthcare

Cipla

0 200 400 600 800 1000 1200 1400 1600 1800

Revenue(USD in Million)

Revenue(USD in Million)

Figure 2.5.2 Revenue of the companies


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Market Capitalization (Rs. Million)

Sun Pharma

Dr. Reddy'sLab

Cadila Healthcare

Cipla

Figure 2.5.3 Market Capitalization

Sun Pharma Dr. Reddy'sLab Cadila

Healthcare Cipla-40,000

-20,000

0

20,000

40,000

60,000

80,000

100,000

Total Income (Rs.Million)

Net Profit (Rs. Million)

Figure 2.5.4 Total Income and Net Profit


Total Income and Net Profit (Rs. Million)

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2.6 Challenges

Even after the increased investment, market leaders such as Ranbaxy and Dr. Reddy’s

Laboratories spent only 5–10% of their revenues on R&D, lagging behind Western

pharmaceuticals like Pfizer, whose research budget last year was greater than the

combined revenues of the entire Indian pharmaceutical industry. This disparity is too

great to be explained by cost differentials, and it comes when advances in genomics

have made research equipment more expensive than ever. The drug discovery process

is further hindered by a dearth of qualified molecular biologists. Due to the disconnect

between curriculum and industry, Pharma in India also lack the academic

collaboration that is crucial to drug development in the West and so far.

Other challenges include:

Greater customer expectations.

Restricted discovery and developing process.

Effective product life-cycle management.

Increase in pricing policies.

Traditional management culture.

Infrastructure challenges.

Talent retention.

2.7. Road Ahead

Growing at a consistent rate, PwC-CII report titled “India Pharma Industry Gearing

up for the next level of growth” suggests that the Indian pharma industry is likely to

be in the top 10 global markets in value terms by 2020. The report highlighted that the

driving growth in the domestic market is due to high burden of disease, good

economic growth leading to higher disposable incomes, improvements in healthcare

infrastructure and improved healthcare.

New small and medium enterprises (SMEs) are also likely to play a substantial role in

the growth of the India's pharma sector. According to the consulting firm Grant


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Thornton, the country will also see the largest number of merger and acquisitions

(M&A) in the pharmaceutical and healthcare sector in the coming years. The

domestic market is likely to contribute 35–40 per cent to the industry in terms of

production with a turnover of about Rs 35,000 crore (US$ 5.70 billion).

Global players can explore opportunities in India by outsourcing research based

capabilities, licensing to establish a common platform to create a complete therapy

range, franchising and joint-ventures to associate with domestic players and use local

talent and expertise to get quick government approval and function better. Some

multinational companies such as Pfizer and Novartis are already taking advantage of

the potential in India through partially or wholly owned subsidiaries.


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3.1 COMPANY PROFILE

COMPANY SNAPSHOT:

Date of Establishment 17-08 1935

Revenue 1580.82 (USD in Millions)

Market Cap 477015.5781937 (Rs. in Millions)

Management Details

Chairperson - Y K Hamied

MD - Subhanu Saxena

Directors - Adil Zainulbhai, Amar Lulla, Ashok Sinha, H R Manchanda, K A

Hamied, M K Hamied, M R Raghavan, Mital Sanghvi, MK Hamied, Pankaj Patel,

Peter Mugyenyi, Rajesh Garg, Ramesh Shroff, Ranjan Pai, S A A Pinto, S

Radhakrishnan, Subhanu Saxena, V C Kotwal, Y K Hamied

Business Operation Pharmaceuticals & Drugs

Background Chemical, Industrial & Pharmaceutical Laboratories, now known as

Cipla, was incorporated 1935.Khwaja Abdul Hamied, the founder of Cipla gave the

company all his patent and proprietary formulas for several drugs and medicines,

without charging any royalty. On August 17, 1935, Cipla was registered as a public

limited company with an authorised capital of Rs 6 lakhs.

Financials Total Income - Rs. 96605.7 Million (Year ending Mar 2014)

Net Profit - Rs. 13883.4 Million (Year ending Mar 2014)


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Bankers Bank of Baroda, Canara Bank , Corporation Bank, HSBC Bank, Indian

Overseas Bank, Standard Chartered Bank, Union Bank of India.

Headquartered in Mumbai, Cipla has over 34 state-of-art manufacturing units which

have been approved by various Ministries of Health and Regulatory Authorities

worldwide. In 2011, it posted revenues of 6483 crore (US $1.2 billion approximately)

and a profit of `960 crore (US $190 million approximately), making it one of the

world’s largest standalone generic pharmaceutical companies which has a presence in

over 180 countries. Its 2000-strong product-range, spanning 65 therapeutic areas,

comprises Active Pharmaceutical Ingredients (API), formulations for human and

animal healthcare, and over the counter (OTC) products.

Founded by Dr Khwaja Abdul Hamied in 1935, Cipla was started with the object of

making India self-sufficient and self-reliant in healthcare. The Chemical, Industrial &

Pharmaceutical Laboratories, as it was then called, established the country’s first

research division dedicated to attaining self-sufficiency in technological development

in 1952. Under the leadership of Dr Yusuf K Hamied, the founder’s son, who has a

doctorate in chemistry from Cambridge, Cipla pioneered API manufacturing in the

country and thus helped lay the foundation for the pharmaceutical industry in India.

Cipla played an active role in the formation of the Indian Drug Manufacturers

Association (IDMA) which consistently strove for 12 years to persuade the Indian


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Government towards formulating the Patent Law, soon after which the Indian Patent

Act of 1970 was enacted. As per the new law, a pharmaceutical company could not

have a patent on its product but could patent the process for manufacturing the

product for a period of seven years. Thus, for the first time ever an Indian

pharmaceutical company was allowed to manufacture any drug and this

revolutionised the healthcare scenario in India, making drugs available and affordable

to Indians.

Cipla covers a wide spectrum of diseases ranging from communicable, non-

communicable, common and emerging diseases to even rare diseases. Cipla was the

first company to introduce a semi-synthetic antibiotic, ampicillin (Ampicyn). It also

introduced propranolol (Ciplar), the first beta-blocker for heart disease and the anti-

asthma drug salbutamol (Asthalin). When India was entirely dependent on imported

Metered Dose Inhalers for its respiratory health, it stopped receiving supplies of these

devices. At that time, Cipla innovated a first of its kind technology to manufacture

MDIs in the country, which has been a boon for asthma patients. Cipla maintains a

global standard across all its products and services.

Cipla has the technological prowess to manufacture products in most dosage forms

across various therapeutic categories, thus giving the company a unique advantage. Its

R&D centres, primarily focused on developing innovative products and drug delivery

systems, have given the country and the world many firsts. It maintains a global

manufacturing standard across all its products and services.

Cipla is probably the only company in India which has medicines for treating rare

diseases. Cipla was the first to introduce an oral iron chelator under the brand name

Kelfer for Thalassemia way back in 1989. In 2001, it pioneered the triple cocktail

drug Triomune for the treatment of HIV/AIDS at a price below ‘dollar a day’. Today

over 70 lakh (seven million) HIV+ patients are being treated and millions of lives

have been saved, and Cipla has become one of the leading world suppliers of both

anti-AIDS drugs and anti-malarial drugs to Africa.


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During the global avian flu pandemic in 2005, Cipla achieved the large-scale

production and supply of Oseltamivir in a record-breaking three months; it was the

only company to supply the drug outside of its originator. In 2009, Cipla launched the

world’s first generic Bosentan, for the treatment of a rare disease called Pulmonary

Arterial Hypertension (PAH). Again in 2010, Cipla raised the hopes of patients

suffering from Idiopathic Pulmonary Fibrosis (IPF) by launching the world’s first

generic Pirfenidone in India called Pirfenex.

The company’s corporate social responsibility initiatives are spearheaded by the Cipla

Charitable Trust which promotes education and provides financial as well as medical

assistance to needy patients. Under the aegis of Cipla Cancer and AIDS Foundation,

the Cipla Palliative Care and Training Centre was started in 1997 at Pune. It is one of

the few centres in India offering the best-in-class palliative care to patients diagnosed

with cancer, absolutely free of cost. The centre applies a holistic approach to provide

all-round care in symptom and pain management and emotional well-being of cancer

patients. The centre also offers training to doctors, nurses and medical social workers.

However the company also had to face some obstacles like,

Initially, the company had to close down upon manufacturing of AZT, the only

known therapy to combat Aids, because of poor sales.

Even after lowering down its cost to $2 compared to international prices of $12,

it continued to be too costly for patients in India. But in 2001, they further

dropped the price to $ 1 to help people, and this act generated undisputed

respect for him, all over.

Cipla has also faced challenges in India and abroad from multinational

pharmaceutical companies seeking to protect their patents on particular

medications, including antiretroviral drugs used to combat HIV infections in

countries like South Africa.

Dr Yusuf K Hamied, Chairman and Managing Director, Cipla Ltd, says, “Success

does not make a company great. What really matters is its contribution towards

making life better for everyone.”


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3.2 MILESTONES

In 1935, Cipla’s founder, Dr. K. A. Hamied set up Cipla to make India self-

reliant in healthcare.

In 1939, Mahatma Gandhi visited Cipla and inspired the founder to make

essential medicines for the country, and strive for self-sufficiency. During

World War II, when India was dependent on imported medicines and there

was an alarming shortage of life-saving drugs, they manufactured them for

the country.

In the 1960s, they pioneered API manufacturing in the country and helped lay

the foundation for the bulk drug industry in India.

In 1970, they spearheaded the New Patent Law by which an Indian

pharmaceutical company was allowed to manufacture a patented product as

long as the process to manufacture it was changed. This enabled Indian

companies for the first time to manufacture any medicines and make them

available and affordable for all Indians.

In 1978, Cipla pioneered inhalation therapy in India with the manufacture of

Metered-Dose Inhaler (MDI), at a time when the country stopped receiving

imported supplies. Today, they have the world’s largest range of inhaled

medication and devices.

In 1994, they launched Deferiprone, the world’s first oral iron chelator which

revolutionized the treatment for thalassemia. For the first time patients with

thalassemia had an option that was affordable, painless and convenient.


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In 1996, they gave the world the first transparent dry powder inhaler which

was so simple and easy to use, it changed the face of inhalation therapy in

India.

2000-Cipla became the first company, outside the USA and Europe to launch

CFC-free inhalers – ten years before the deadline to phase out use of CFC in

medicinal products.

In 2001, Cipla pioneered the access to HIV treatment by making

antiretrovirals (ARVs) available at less than a ‘Dollar a Day'. The cost of

treatment dramatically fell from $12,000 per patient per year to $300 per

patient per year. This caused a revolution where HIV treatment became a

reality for the world and millions of lives could be saved.

In 2002-Four state-of-the-art manufacturing facilities set up in Goa in a record

time of less than twelve months.

In 2003-Launches TIOVA (Tiotropium bromide), a novel inhaled, long-acting

anticholinergic bronchodilator that is employed as a once-daily maintenance

treatment for patients with chronic obstructive pulmonary disease

(COPD).Commissioned second phase of manufacturing operations at Goa.

During the 2005 Bird Flu epidemic, Cipla produced an anti-flu drug within a

period of 2-3 months, which would have normally taken at least 3 years to

develop.

In 2007-Sets-up state-of-the-art facility for manufacture of formulations at

Sikkim.


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In 2010-Sets up state-of-the-art facility for manufacture of formulations at

Indore.

In 2012, Cipla made a breakthrough in reducing the prices of cancer drugs,

thus making world-class medicines affordable and accessible to cancer

patients.

Cipla are committed to addressing the unmet medical needs of the world by

venturing into newer challenges in platform technologies, biotechnology and

stem cells.

Cipla will continue to support, improve and save millions of lives with our high-

quality drugs and innovative devices. And with the dedication of 20,000 employees,

they are ready to face the future challenges of healthcare.

3.3 MISSION

Cipla’s mission is to be a leading global healthcare company which uses technology

and innovation to meet every day needs of all patients.

3.4 USP

Cipla has made a Commitment to make medicines affordable and accessible

particularly to cancer patients.

3.5 PROMOTERS PROFILE

Dr. K. A. Hamied (1898-1972) was an Indian

nationalist and anti-imperialist scientist who

founded Cipla, India's oldest pharmaceutical

company in 1935. His son, Yusuf Hamiedheaded

the company after him for the next 52 years.

Hameid was born in Aligarh, Uttar Pradesh, and

later graduated from Allahabad University in Allahabad, Uttar Pradesh and held M.A.

and PhD degrees from the Humboldt University of Berlin in Germany. He was a


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disciple of M.K. Gandhi and former founder professor along with Zakir Husain of

the JamiaMiliaIslamia in Aligarh, now based in Delhi.

Hamied followed Mahatma Gandhi's Indian nationalism. Hamied's family raised

money to send him to study chemistry in England, India's colonial master, in 1924.

Instead, he changed ships and went to Germany, then the world's leader in chemicals.

On a Berlin lake, he met a Lithuanian Jewish socialist, whom he married. They fled as

the Nazis rose to power in Germany.

Chemical, Industrial and Pharmaceutical Laboratories (CIPLA) was founded in 1935,

making it the oldest pharmaceutical company in India. His eldest son Yusuf Hamied,

who did study chemistry in England, is now Chairman of Cipla. Yusuf still refers to

his chemistry notebooks from Cambridge.

During the last four decades of his life, he played an important role in raising the

pharmaceutical and chemical industry standards in India to an extraordinarily high

level through founding the firm Cipla.

Dr. Hamied was an honorary professor and a member of the executive council of

the Aligarh Muslim University, member of the Senate of Bombay University and a

fellow of the Royal Institute of Chemistry, UK. He was also a member of the Bombay

Legislative Council from 1937–1962, refusing the offer of becoming a Muslim

Minister in the cabinet in Bombay. Hamied also served as Sheriff of Bombay.

Yusuf Khwaja Hamied is a leading Indian

scientist and chairman of Cipla, a socially

conscious generic pharmaceuticals company

founded by his father Khwaja Abdul

Hamied in 1935.

He was awarded the Padma Bhushan, India's

third highest civilian honour by Government of India in 2005.


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Born in Vilnius, Lithuania,on July 25th 1936. Yusuf Hamied was raised in Mumbai

(previously Bombay). His Indian Muslim father and Russophone Jewish mother met

in pre-war Berlin, where they both were graduate students. He holds

a Ph.D. in chemistry from Christ's College, Cambridge. He still uses his chemistry

notebooks from Cambridge when he develops new syntheses of drugs.

He is an alumnus of the Cathedral and John Connon School in Bombay.

Affectionately called Yuku by his close friends, Hamied is fond of Western classical

music and has been close friends with the world-famous conductor Zubin Mehta since

boyhood.

Hamied is best known outside India for defying large Western pharmaceutical

companies in order to provide generic AIDS drugs and treatments for other ailments

primarily affecting people in poor countries. He was awarded the Padma Bhushan by

the Government of India in 2005.

Hamied has led efforts to eradicate AIDS in the developing world and to give patients

life-saving medicines regardless of their ability to pay, and has often been

characterized as a modern-day Robin Hood figure as a result.

Former head of Johnson and Johnson AjitDangi says plainly "In Africa, Cipla is a

temple and Dr.Hamied is God." To this Hamied has countered "I don't want to make

money off these diseases which cause the whole fabric of society to crumble".

In September 2011, in a piece about how he was trying to radically lower costs of

biotech drugs for cancer, diabetes and other noncommunicable diseases, The New

York Timeswrote of Hamied:

Dr. Yusuf K. Hamied, chairman of the Indian drug giant Cipla Ltd., electrified the

global health community a decade ago when he said he could produce cocktails of

AIDS medicines for $1 per day — a fraction of the price charged by branded

pharmaceutical companies. That price has since fallen to 20 cents per day, and more

than six million people in the developing world now receive treatment, up from little

more than 2,000 in 2001.

Yusuf Hamied has also been enormously influential in pioneering development of

multi-drug combination pills (also known as fixed-dose combinations, or FDCs),


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notably for HIV/AIDS, tuberculosis (TB), asthma and other ailments chiefly affecting

developing countries, as well as development of pediatric formulations of drugs,

especially those benefiting children in poor settings. These innovations have greatly

expanded access to medicine and increased drug safety by ensuring proper dosages

are taken. He is also highly regarded for his leading role in expanding the production

of bulk drugs and "active pharmaceutical ingredients" (APIs, the active chemical

components in medicines) in India.

In 2009 the Yusuf Hamied Centre was opened at Christ's College, Cambridge.

Yusuf Hamied has been the subject of in-depth profiles in The New York

Times, Time magazine, The Guardian, Le Monde, The Economist, the Financial

Times, The Times (London), Corrieredella Sera, Der Spiegel, Wired and numerous

other leading publications, as well as on television outlets such as ABC News, the

BBC, CNN and CBS' 60 Minutes.

He has been bestowed many honours, including:

The country's highest civilian award, the Padma Bhushan by the President Dr.

A.P.J Abdul Kalam in 2005.

Two Chemexcil Awards for exports (1979 and 1982)

Sir P. C. Ray Award for development of indigenous technology (1983).

A National Award from the Department of Science and Technology,

Government of India for successful commercialization of publicly funded R &

D.

In 2002, he received another Lifetime Achievement award from Express

Pharma Pulse.

Dr. Hamied was elected a Fellow of Christ's College, Cambridge, UK in 2004.

In February 2013, he announced his retirement plans from Cipla after remaining

managing director of the company for last 52 years. At the time, he was 28th

richest Indian as per Forbes.

Yusuf Hamied was awarded the 'CNN-IBN Indian of the Year' in the category

of business by CNN-IBN in 2012 for "for taking on multinational pharma

companies and making some of the essential drugs more affordable to the


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masses in the developing countries. In late 2013, he was also named one of the

India's "25 Greatest Global Living Legends" by news broadcaster NDTV.

Yusuf Hamied's critical role in the battle for mass antiretroviral treatment in

Africa is portrayed in the award-winning documentary Fire in the Blood (2013

film).

His contribution to India and the world is truly inspiring, and practically

unforgettable.

3.6 ACHIVEMENTS AND AWARDS TO CIPLA

The company won the Forbes Asia's “Best Under A Billion” List from Forbes

Magazine.

Cipla also won the Most Profitable Company overall among those “Under a

Billion in the Region’s Top 200 Small and Mid Size companies” from Forbes

Magazine.

Trust Research Advisory (TRA) declared Cipla the ‘Most Trusted Brand’ in

Indian pharmaceutical industry, 2011

Pharmaceuticals Export Promotion Council Award for Outstanding Export

Performance (Drugs and Pharmaceuticals), 2009

Listed in Forbes Asia’s ‘Best under a Billion’, 2007

SCRIP Award for Best Company in an Emerging Market, 2006


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4.1 PRODUCT PROFILE

The company focuses on development of new formulations and has a wide range of

pharmaceutical products.

Pharmaceuticals: Cipla manufactures anabolic steroids, analgesics/antipyretics,

antacids, anthelmintics, anti-arthritis, anti-inflammatory drugs, anti-TB drugs,

antiallergic drugs, anticancer drugs, antifungal, antimalarials, antispasmodics,

antiulcerants, immunosuppressants etc,

Animal Health Care Products: These include: aqua products, equine products,

poultry products, products for companion animals, and products for livestock animals.

OTC: These include: child care products, eye care products, food supplements, health

drinks, life style products, nutraceuticals & tonics, skin care products, and oral

hygiene products.

Flavour & Fragrance: Cipla manufactures a wide range of flavours, which are used

in foods and beverages, fruit juices, baked goods, and oral hygiene products. Cipla

fragrances have wide ranging applications such as in personal care products, laundry

detergents and room fresheners.

It offers prescription drugs, bulk drugs, animal products and pesticides. It also offers

a wide range of food and beverages, baked foods, oral hygiene products, detergents,

room fresheners and personal care products.


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Almost 55% of its overall income from its operations comes from outside India. It has

5,500 registered products in various countries. Cipla offers drugs used for treatment of

cancer, Alzheimer's, arthritis, Parkinson’s, cardiovascular diseases and many more. It

also offers drugs that prevent transmission of AIDS from mother to child. The

company provides consulting services on preparation of products and materials

conducts plant evaluation and supplies plant equipment’s.

Cipla has set up two institutes namely Dr K.A Hamied Institute and Cipla Cancer

Palliative Care & Training Centre. It has a presence across 170 countries with

manufacturing units approved by regulatory authorities like USFDA, WHO-Canada

and MHRA-UK, among others.

Cipla was first company outside US and Europe to launch CFC-free inhalers. In 2007

Cipla launched oral emergency contraceptive pill under the brand name I-Pill. Cipla

also launched a breakthrough screening technology in India called the ‘No Touch

Breast Scan (NTBS); ' the first-ever painless, non-invasive and radiation-free breast

scanning technique for detecting breast cancer at an early stage.

In 2009, Cipla launched generic versions of anti-flu drugs oseltamivir and zanamivir

in the local market to treat the H1N1 influenza, spreading across the globe and in

India. In 2010, Piramal Healthcare Limited announced the signing of a definitive

agreement with Cipla Limited for purchase of all intellectual property rights in India

related to 'i-pill' for an aggregate consideration of Rs 95 crore.

Cipla's Research & Development (R&D) is focused towards developing new

products, improving existing products as well as drug delivery systems and expanding

product applications. Hundreds of scientists work on all facets of pharmaceutical

development and technology.

In-house R&D forms the backbone of our operations. With almost 5-6% of the

company turnover being invested towards R&D each year, our strategy focuses on:

Developing new drug formulations for existing and newer drug substances.


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Improving processes for existing API and formulation products.

Developing new drug delivery systems for existing and newer active drug

substances, as well as newer medical devices, mainly in the area of

respiratory medicine.

Tie-ups with independent research teams to develop new products.

Strengthening our intellectual property, including the patenting of new

products, drug delivery systems and medical devices, mainly in the area of

respiratory medicine.

Conducting clinical and bio-equivalence studies for obtaining regulatory

approvals for new products and services.

In addition, for their international business, the R&D team works with our

strategic partners to file Drug Master Files (DMFs) and Abbreviated New

Drug Applications (ANDAs) in the US, and seek marketing authorizations in

Europe and file product registrations in other jurisdictions.

Cipla has earned a name for maintaining world-class quality across all their

manufacturing units, products and services. They have consistently

introduced more than 40 products annually, over the last decade.

They have been granted about 100 patents. Patent filing includes drug

substances, drug products, platform technologies, IP on polymorphs and

crystallinity, and medical devices.

139 DMFs, 87 registered ANDAs and 25 ANDAs under review in the US.

About 1000 DMFs for a total of 101 APIs; 49 COS approved.

Over 700 marketing authorizations in Europe.

Over 10,000 product registrations globally.


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49 products pre-qualified by World Health Organization (WHO).

Supported 2 NDA filings for our partners and have 16 NDAs of our own.

4.2 CIPLA’S POOL OF INNOVATION

Cipla has over 2000 products in 65 therapeutic categories available in over 40 dosage

forms, including:

Liposome Injection

Microsphere Injection

Topical Delivery System

Inhalation Technology:

o Metered-Dose Inhaler

o Dry Powder Inhaler & Respiratory Solutions

Nasal Drug Delivery

Ophthalmic Solutions

Pre-filled Syringe

Hormone Injection

Nanotechnology


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5.1 ORGANIZATIONAL STRUCTURE

An organizational structure defines how activities such as task allocation,

coordination and supervision are directed towards the achievement of organizational

aims. It can also be considered as the viewing glass or perspective through which

individuals see their organization and its environment.

An organization can be structured in many different ways, depending on their

objectives. The structure of an organization will determine the modes in which it

operates and performs.

Organizational structure allows the expressed allocation of responsibilities for

different functions and processes to different entities such as the branch, department,

workgroup and individual. Organizational structure affects organizational action in

two big ways. First, it provides the foundation on which standard operating

procedures and routines rest. Second, it determines which individuals get to

participate in which decision-making processes, and thus to what extent their views

shape the organization’s actions.

5.2 TYPES OF ORGANIZATION STRUCTURE

Organization structure is defined as "The logical arrangement of task and the network

of relationships and roles among the various positions established to carry out the

activities necessary to achieve the predetermined objectives of business". Internal

Organization structure constitutes the arteries and veins through which the blood of

work flows in the body of Organization.


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Internal Organization structures can be broadly classified into the following

types/forms:

1. Line Organization structure.

2. Functional Organization structure.

3. Line and staff Organization structure.

4. Product Organization structure.

5. Committee and Matrix Organization structure.

5.2.1 Line Organization Structure

In the line Organization, the line of authority moves directly from the top level to the

lowest level in a step-by-step manner. It is straight and vertical. The top-level

management takes all major decisions and issues directions for actual execution. Thus

authority moves downward and also step-by-step. The responsibility, on the other

hand, moves in the upward direction.

5.2.2 Functional Organization Structure

In the functional Organization, the job of management is divided according to

specialization. As a result, functional departments are created. The scope of work of

the department is limited but the area of authority is unlimited.

5.2.3 Product Organization Structure

The grouping of activities on the basis of products is very popular with large

organizations having distinct type of products. Under this method, all activities related

to one type of product are put together under one department under the direction of a

production manager. Product wise departmentation is also known as multi-functional

product departmentation, because each product department handles all the functions

concerning it.

5.2.4 Committee and Matrix Organization Structure


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It facilitates the horizontal flow of skills and information. It is used mainly in the

management of large projects or product development processes, drawing employees

from different functional disciplines for assignment to a team without removing them

from their respective positions.


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5.3 THE FUNCTIONAL ORGANIZATIONAL STRUCTURE OF CIPLA


CEO

MANAGING DIRECTOR

TECHNICAL DIRECTOR

SENIOR FACTORY

MANAGEMENT

UNIT HEAD

PRODUCTION

TABLET HEAD

COMPRESSION TEAM

DISPENSING TEAM

GRANULATION TEAM

COATING TEAM

TOPICAL HEAD

TOPICAL TEAM

PACKING

DEPARTMENT HEAD

TOPICAL PACKING

TABLET PACKING

DISPENSING

STORES

DEPARTMENT HEAD

INVENTORY

MANAGEMENT

SYSTEM

PACKING MATERIAL

GRN PREPERAT

ION

DISPATCH TEAM

RAW MATERIAL

QUALITY ASSURANCE

QUALITY ASSURANCE

HEAD

QUALITY MANAGEMENT

SYSTEM

BATCH RECORD REVIEW

QA OBSERVER

REGULATORY AFFARIS

LAB QA

QUALITY CONTROL

QUALITY CONTROL

HEADFUNCTIO

NAL HEAD

ANALYTIC

ALL GROUP

LAB SUPPORT GROUP

FINANCE

FACTORY FINANCE

MANAGERACCOUNTS OFFICER

HUMAN RESOURCE

FUNCTIONAL HEAD

TRAINING &

DEVELOPMENT

PAYROLL

SECURITY

CSR

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A functional organizational structure is a structure that consists of activities such as

coordination, supervision and task allocation. The organizational structure determines

how the organization performs or operates. The term organizational structure refers to

how the people in an organization are grouped and to whom they report. One

traditional way of organizing people is by function. Some common functions within

an organization include production, marketing, human resources, and accounting.

This organizing of specialization leads to operational efficiency where employees

become specialists within their own realm of expertise. The most typical problem

with a functional organizational structure is however that communication within the

company can be rather rigid, making the organization slow and inflexible. Therefore,

lateral communication between functions become very important, so that information

is disseminated, not only vertically, but also horizontally within the organization.

Communication in organizations with functional organizational structures can be rigid

because of the standardized ways of operation and the high degree of formalization.

As a whole, a functional organization is best suited as a producer of standardized

goods and services at large volume and low cost. Coordination and specialization of

tasks are centralized in a functional structure, which makes producing a limited

amount of products or services efficient and predictable. Moreover, efficiencies can

further be realized as functional organizations integrate their activities vertically so

that products are sold and distributed quickly and at low cost.

Even though functional units often perform with a high level of efficiency, their level

of cooperation with each other is sometimes compromised. Such groups may have

difficulty working well with each other as they may be territorial and unwilling to

cooperate. The occurrence of infighting among units may cause delays, reduced

commitment due to competing interests, and wasted time, making projects fall behind

schedule. This ultimately can bring down production levels overall, and the company-

wide employee commitment toward meeting organizational goals.

Here the job of the management is divided according to specialization like

Production, Packing, Stores, Quality Assurance, Quality Control, Finance, Human


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Resource etc. As a result, functional departments are created. The scope of work of

the department is limited but the area of authority is unlimited.

In Cipla there is a Technical Director who reports to Managing Director and a Factory

Head for each of the factories who report to the Technical Director. Unit Heads are

present at each of the 10 units in Cipla. Section Heads report to the Department Heads

of each department and it ends with the employees to whom the trainees have to

report to.

5.4 ORGANIZATONAL DESIGN:

Organization design is the deliberate process of configuring structures, processes,

reward systems, and people practices to create an effective organization capable of

achieving the business strategy. The organization is not an end in itself; it is simply a

vehicle for accomplishing the strategic tasks of the business. A well-designed

organization helps everyone in the business do her or his job effectively. A poorly-

designed organization (or an organization by default) creates barriers and frustrations

for people both inside and outside the organization.

5.5 ORGANIZATIONAL CULTURE:

Organizational culture is the personality of the organization. Culture is comprised of

the assumptions, values, norms and tangible signs (artifacts) of organization members

and their behaviors. Members of an organization soon come to sense the particular

culture of an organization. Culture is one of those terms that are difficult to express

distinctly, but everyone knows it when they sense it. For example, the culture of a

large, for-profit corporation is quite different than that of a hospital which is quite

different than that of a university. You can tell the culture of an organization by

looking at the arrangement of furniture, what they brag about, what members wear,

etc. -- similar to what you can use to get a feeling about someone's personality.


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Corporate culture can be looked at as a system. Inputs include feedback from, e.g.,

society, professions, laws, stories, heroes, values on competition or service, etc. The

process is based on our assumptions, values and norms, e.g., our values on money,

time, facilities, space and people. Outputs or effects of our culture are, e.g.,

organizational behaviour’s, technologies, strategies, image, products, services,

appearance, etc.

The concept of culture is particularly important when attempting to manage

organization-wide change. Practitioners are coming to realize that, despite the best-

laid plans, organizational change must include not only changing structures and

processes, but also changing the corporate culture as well.

There's been a great deal of literature generated over the past decade about the

concept of organizational culture -- particularly in regard to learning how to change

organizational culture. Organizational change efforts are rumoured to fail the vast

majority of the time. Usually, this failure is credited to lack of understanding about

the strong role of culture and the role it plays in organizations. That's one of the

reasons that many strategic planners now place as much emphasis on identifying

strategic values as they do mission and vision.

In Cipla they follow an open culture where in a 360 degree feedback is taken. The

suggestions given by the employees are taken for the betterment of the company.

However the presence of employees is not appreciated at the meetings.


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6.1 PRODUCTION DEPARTMENT

Organizational Chart


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The production department is basically divided into three sections:

1. Granulation


MANAGING DIRECTOR

TECHNICAL DIRECTOR

SENIOR FACTORY

MANAGEMENT

UNIT HEAD

TABLET DEPARTMENT

HEAD

DISPENSING TEAM

GRANULATION TEAM

COMPRESSION TEAM

COATING TEAM

TOPICAL DEPARTMENT

HEAD

TOPICAL TEAM

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2. Compression

3. Coating

Tablets and Topicals are the two main types of product lines in Cipla (unit -3)

6.1.1 Granulation:

The process, in which the Active Pharmaceutical Ingredient (API) and Excipients

(Non-Active Pharmaceutical Ingredient) are mixed, processed to form the uniform

size granules.

There are three type of Granulation:

1. Wet Granulation

Here water is the ingredient that is used to bind the agents together.

2. Dry granulation

Binding agents other than water are used to bind the ingredients

3. Direct compression

Compression is done directly without using any binding agents, i.e. it is ready

to be compressed.

There are Seven Granulation areas in Cipla, where in four are wet granulation areas,

two are dry granulation areas and one direct compression.

The process of Granulation begins when the materials are dispensed to the Production

Department by the stores department according to the specifications. The material

moves from the Stores department on the ground floor to the production department

on the first floor with the help of a lift. The dispensed material then moves to the

Sifting area then proceeds to the Binder area and finally reaches the Granulation area

after completion of the granulation process it proceeds to in-process storage area and

later moves to the later stages of Production. The material that has been Granuled has

a validity of 45 days, that is, it has to be compressed before the said time.

Wet Granulation Direct Compression Dry Granulation

RECEIVE THE DISPENSE MATERIAL


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SIFTING

(Vibratory Sifter)

PREPARATION OF

BINDER

(Steam Kettle)

BLENDING AND

LUBRICATION

(Octagonal Blender)

PREMIXING

(Planetory Mixer

/Octagonal Blender)

GRANULATION

(Saizoner / Fluid Bed

Equipment)

COMPACTION

(Roll Compactor)

SIZING

(Vibratory sifter / Multi-

mill / Comill)

SIZING AND MILLING

(Vibratory sifter / Multi-

mill)

BLENDING AND

LUBRICATION

(Octagonal Blender)

BLENDING AND

LUBRICATION

(Octagonal Blender)

Weight the Lubricated granules and Transfer to In-process area

Material Ready for Compression

The Equipment, Principle and use is as follows:

1. Vibratory Sifter:

Principle: It works on the vibratory and gyratory motion.

Use: It is used to remove the foreign practices and to have the same particle

size for further process.

2. Steam Kettle:

Principle: It works on the Steam Jacketed pressure phenomenon.

Use: It is used to prepare the binder for binding the powder material to form

the granules.

3. Saizoner:

Principle: It is the High Shear mixer.

Use: It is used prepare the granules from the API, Excipients and Binder by

High Shear Mixing Phenomenon.


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6.1.2 Compression:

Compression is the compaction of lubricated granules or powders to form solid mass

having uniform and different size and shape by the help of punches and dies.

Areas of Compression section are:

1) In Process Quality Assurance (IPQA):-

In IPQA, they check all the parameters of the tablets, group weight of tablets,

dimension, hardness and friability and disintegration test should be carried out

as per the respective BMR. The in-process tests on tablets are carried out in

the IPQA area before start of the compression as well as at specified interval

during compression. The equipment used for the in process test in the IPQA

includes weighing balance, multi check hardness tester, disintegration tester

and friability tester and Dyna scan for appearance checking.

2) Wash area:-

A separate wash area is provided for compression section. In washing area

they clean the compression machine spare parts during product to product

machine cleaning and during batch to batch machine cleaning. Also they clean

the empty granules IPC’s, ancillary equipment’s and processing utensils like

SS and Teflon accessories, stainless steel bin, ladle, vessel stand, jar etc. they

prepare the sanitizing solution and teepol solution in the washing area which is

required for cleaning of cubicles and machine & machine spare parts. They

clean sanities the washing areas at the end of the shift as well as sanitation

done at the end of week to avoid the microbial growth in washing area.

3) Clean equipment area:

This area is only to keep machine parts, IPC and clean machine with proper

labelling. After cleaning of the equipment and machine parts are transferred to

the clean equipment area.

4) Spare parts area:

In spare part area they store the punches, lubrication oil, machine tools etc.

The punches and dies are stored in the punch cabinet with proper labelling and


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proper documentation. The punches are polished using manually and

automatically in polishing machine as and when required.

5) In-process storage area:

In-process storage area is prepared for the storage of in-process material of the

compression department.in in-process area they store the completed

compressed batches. Bulk finish product status label is affixed to each batch.

After getting the release by the QC the approved label is affixed to the

respective batch. As per the requirement of coating or packing the batches are

issued to respective department. The materials compressed are next shifted to

the coating area if needed.

6.1.3 Coating

After the stage of compression where the Tablet or Topical is formed the stage of

coating is the next. Coating is done for three main reasons:

1) For the control release of the product

2) Elegancy of the product

3) Better taste of the product

Coating is of the product can be Sugar coating, Film coating and Intric coating. Gas

coater is used for large batches and Neo Coater is used for smaller Batches. The

coating of a product is done depending on different factors such as humidity,

temperature, bitterness of the product, elegancy like for tablets for children is mostly

dark coloured and those for adults is lighter coloured.

There are various checks that are being performed while doing Coating of the product

so as to avoid:

Logo Bridging

Logo infilling

Picking/ Sticking

Twinning

Core erosion

Tablet to tablet colour variation


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Cracking

Edge chipping

Peeling etc.

6.2 PACKING DEPARTMENT


GRANULATION

COMPRESSION

COATING

Goa


In the Packing Department of Cipla (Unit 3) there are 11 Pack lines which include 2

Packing halls, 3 Bottle pack lines, 1 Stripper line and 5 Blister pack lines. Products

which are packed include Blisters, Topicals and Bottles.

6.2.1 Functions

The functions of the Packing Department are as follows:

1) Planning:

Central Planning department in consultation with Production Manager/

Production Head shall give the requirement of products for local market as

well as export market for the following month.


MANAGING DIRECTOR

TECHNICAL DIRECTOR

SENIOR FACTORY

MANAGEMENT

UNIT HEAD

DEPARTMENT HEAD

TABLET PACKING

TOPICAL PACKING DISPENSING

Goa

For local market the requirement shall be given for the following month along

with the tentative requirement for next three months by last week of every

month and for export market, the central planning department shall give

requirement for the following month.

2) Machine scheduling:

The Production Manager/ Production Head shall prepare schedule for

individual machine on the basis of demands for various products for local as

well as export market. Certain points need to be considered while scheduling

the machine:-

Priority of product

Bulk finish availability with release

Packing material availability with release

Standard packing material specifications

Machine Capacities

Change parts availability

Manpower

Batch Packing Record availability

Machine schedule shall be prepared on or before last day of every

month and the copies of which have to be sent to:

a) Factory Management

b) Production Department

c) Quality Control Department

d) Stores Department

e) Packing Department

f) Quality Assurance Department

There are various Work Centres in Packing department like Blister

packing, Strip packing, Bulk packing, Liquid filling & packing etc.


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3) Execution of Packing Plan:

The Packing department shall give requisition in the authorized format

for issuance of batch packing record on the production system to

Quality Control department. The requisition shall be given one day in

advance prior to the requirement.

The Quality Assurance department shall issue the required BPR.

Packing department head/ authorized person shall authorize the work

order and sign in batch number log and issuance log.

Packing department shall raise the Product Release Request Form and

sent it to QC department. QC department shall issue A.R.No and

specify the samples need to be withdrawn during packing process by

QA department before sending it back to packing department.

The packing department shall give authorized work order to stores

department one day in advance prior to the requirement as intimation

for issuing the packing materials.

The packing work order contains all the details viz product name,

batch no, standard packing material requirement, batch size,

manufacturing date, expiry date and other required information.

The stores officer shall check he availability of required quantity of

released packing materials, after receiving authorized work order.

All packaging material shall be dispensed from stores one day in

advance or in the morning of the day of packing.

The stores officer and packing officer check the release status of

packing materials, ‘passed labels’, A.R.No., item code, quality before

dispensing.

Line clearance checklist to be filled as per Standard Operating

Procedures (SOP).

Line clearance checklist to be filled as per SOP.

After material is dispensed the stores & packing officer signs in the

respective columns of the work order page and dispensing label. The

packing material is transferred to packing department in cages under

lock and key with proper dispensing label and status.


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Commencement of daily work:

Shift schedule shall be prepared for persons working in

department by department head.

Officer ensures cleanliness of machine cubicles,

temperatureand humidity at the start of batch and record it.

The Packing officer shall confirm the item code of dispensed

packing materials against the item code mentioned in the work

order page.

The dispensed primary packing materials shall be transferred to

primary cubicle. Secondary and tertiary packing material shall

be transferred to packing line.

The packing officer shall transfer the release bulk of the

respective batch after confirming passed label affixed on

consignment card and gross weight of IPC’s as mentioned on

bulk finished product label.

The production officer shall check and QA officer shall certify

the initial set up of machine as per SOP.

The initial proof of blister foil, label, carton, outer carton,

packing insert shipper label shall be checked by two production

officers and certified QA officer. They then attach the proofs to

BPR.

The packing officer shall certify the first shipper packed and

raise shipping mark requisition in case of export as per SOP.

The packing officer shall send PRRF to QA department as an

intimation of starting of packing activity.

All the observations and in-process checks shall be recorded in

BPR.

The percentage of the rejection shall be calculated after

intervals during the run of the batch. If rejection is found more

than the standard, action is taken immediately.

Defective strips shall be defoiled simultaneously and are sorted

and checked by packing officer, verified by QA officer.


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Packing material complaints and market complaints shall be reviewed by

department head.

The production officer shall submit the completed BPR to QA for review. The

reviewed BPR shall be complied by production officer for any deficiencies

observed in BPR.

Balance primary packing materials shall be returned to stores through an

Excess Material Return Memo (EMRM) authorized by department head.

If any pack stock is done, all checked cartons from the shipper shall be re-

passed through check weigher and then packed into shipper. The production

officer shall check the shipper and sign across the sealing position and shipper

to be sealed.

4) Dispatch of Finished goods:

Once the goods are packed they are sent to stores and later exported or sent to

the local warehouses.

6.3 STORES DEPARTMENT



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The stores department stores the raw materials that is required for production as well

as packing of finished products. They also indent the materials that would be needed.

They receive the materials and also dispense the materials according to specifications

and once the finished products are ready they are sent to the warehouse or else

exported.

Raw materials is any ingredient intended for use in the production of intermediate or

APIs. These may include starting materials, process aids, solvents and reagent. The

Raw Materials consists of Active Pharmaceutical Ingredients (API) and Excipients.

The packaging material is of three types:

Primary

Secondary

Tertiary


MANAGING DIRECTOR

TECHNICAL DIRECTOR

SENIOR FACTORY MANAGEMENT

UNIT HEAD

STORES HEAD

RAW MATERIAL/ PACKING MATERIAL

RECEIPT GRN PREPARATION

RAW MATERIAL PACKING MATERIAL EXCISE/ DISPATCHINVENTORY

MANAGEMENT SYSTEM ENTRY

Goa

6.3.1 Functions of Stores Department

6.3.1.1 Indenting of materials in stores:

Stores department will work out requirement of raw and packing material

at unit based on the three months production planning done by the

planning department.

Based on this requirement unit stores will raise indent for raw & packaging

material which is sent to Purchase Department.

Purchase Department releases the Purchase Order (P.O.) against the raised

indent to approved suppliers.

On receipt of P.O. respective supplier will send the material against the

Purchase Order to the units.

6.3.1.2 Receipt of Material:

Once material arrives at the security gate in vehicles,security personnel

will confirm the unit to which material belongs and informs the same to

concerned stores.

Stores personnel will instruct the security personnel to send the transporter

of the vehicle with the documents to the stores office.

Stores personnel checks documents against the Purchase Order/ Indent. If

documents are found OK, stores Personnel will inform the security

personnel to allow the material be taken inside.

When vehicle arrive stores personnel will check the vehicle for its

cleanliness.

Material is then unloaded on company’s pellets at the Unloading Bay.

After all the material is unloaded, the delivery challan is checked for

details such as if the material is received from Approved Supplier, item

name, item code, batch no./lot no., quantity, name & site of manufacturer

etc.

Material is also checked for any damaged containers and damaged,

tampered or different coloured seals.


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Stores personnel will verify the documents received with the material like

the delivery challan, COA etc. and fill the checklist as per concerned SOP.

Material containers are cleaned/ dedusted by lint free cloth/ vacuum

cleaner externally in the dedusting booth.

Weighing of material is done once material is taken inside to check the

gross weight.

6.3.1.3 Storage of material

Material is transferred to Quarantined area as per required storage

conditions with “QUARANTINE AWAITING GRN” status label.

Dedicated areas are available transfer of raw material and packaging

material.

Cold storage provision is also available for the material requiring to be

stored in 2-8 degree temperature.

Packing material is stored in dedicated area as Primary, Secondary and

Tertiary packing material.

Location of stored material is updated in Location Tracking Software.

GRN is prepared by feeding the details of consignments in Inventory

Management System (IMS) software.

Consignment card is printed which will replace Quarantine awaiting GNR

status label.

The GRN is handed over to QC.

6.3.1.4 Sampling of material

Sampling is the process of removal of small portion of material from a

large lot for QC analysis.

Sampling is carried out by QC personnel in sampling booth.

Dedicated area is provided for man & material entry to the sampling

booth.

After sampling QC will affix “UNDER TEST” labels on the consignment

card and individual container wherever applicable.


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6.3.1.5 Analysis of material

Analysis is done at QC as per respective specifications.

On release of material PASSED label will be affixed by QC personnel on

the UNDER TEST label on the consignment.

If the material is rejected, REJECTED label will be affixed by QC

personnel on the “UNDER TEST” label on the consignment.

6.3.1.6 Dispensing of material

It is weighing of the material as per standard quantities mentioned on the

work order by following GMP standards.

Dispensing is carried out by stores in presence of production personnel.

Dedicated areas are available for man and material movement to the

dispensing area.

Dedicated areas are available for transfer of dispensed raw material and

packaging material.

Material is issued to Production/ Packing department on First In First out

(FIFO) and First Expiry First Out (FEFO) basis.

6.3.1.7 Dispatch of material

Once the drug has undergone all stages of manufacturing and packing including

testing, the finished goods come in Finished Goods Stores along with Daily Packing

Report (DPR) given by the packing department.

QA updates the status as UNDER TEST on each pallet of Finished Goods

Store.

After QC release QA updates the UNDER TEST status as PASSED on

each pellets of Finished Good is now ready for dispatch.

Stores will arrange for vehicle as per required storage condition.


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Cleanliness and safety of the vehicles are checked and verified before

loading.

Material then loaded in vehicles and sent to different warehouses.

Material Flow Diagram in Stores Department:

6.4 QUALITY ASSURANCE DEPARTMENT


MATERIAL IS RECEIVED AT STORES FROM

APPROVED SUPPLIERS.

MATERIAL IS QUARANTINED IN

RESPECTIVE STORAGE AREAS

SAMPLING OF MATERIAL IS DONE BY QUALITY

CONTROL STAFF.MATERIAL WILL BE

APPROVED OR REJECTED BASED ON ANALYSIS.

APPROVED MATERIAL WILL BE DISPENSED FOR PRODUCTION/ PACKING

BASED ON WORK ORDER.

UPON COMPLLETION OF MANUFACTURING AND

PACKING OF PARTICULAR BATCH, MATERIAL WILL

BE TRANSFERRED IN FINISHED GOODS STORES

UPON QC RELEASE, THE FINISHED PRODUCT IS

THEN READY FOR DISPATCH TO DIFFERENT

WAREHOUSE

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Quality Assurance (QA) is a concept covering all matters that individually or

collectively influence the quality of a product. It is the totality of the arrangements

made with the object of ensuring that pharmaceutical products are of the quality

required for their intended use. Quality Assurance ensures effective implementation

of current Good Manufacturing Practices there by ensuring the excellence in products,

Processes and systems.

6.4.1 Functions


MANAGING DIRECTOR

TECHNICAL DIRECTOR

CORPORATE QUALITY

ASSURANCE HEAD

HEAD QUALITY ASSURANCE

HEAD QUALITY CONTROL

UNIT QUALITY ASSURANCE HEAD

UNIT QUALITY CONTROL HEAD

FUNCTIONAL HEAD

QUALITY CONTROL ANALYTICAL

GROUP

QUALITYCONTROL LAB SUPPORT

GROUP

Goa

The two basic functions are:

1. Functions of Observation:

To observe the activities are carried out as per the standard operating

procedures and adherence to cGMP. Observations to be informed to the first

line officers, who will then take corrective actions in consultation with the

department head and QA officer. Focus of the observation should be develop

sharper control points, identify areas of wastages, ensure online

documentation, adherence to SOPs, counter check in process control

parameters, adherence to cGMP norms.

2. Function of Document review:

All the batch documents should be reviewed independently to ensure

authorization by competent persons, all entries made are legible, correct and as

per the desired time interval and frequency, entries are signed for doer’s and

checkers person, timings of each process, yields at different stages,

attachments of in process test results including Quality Control results and

feedback on overall neatness of documents with respect to overwriting,

cancellations and omissions.

Apart from the above functions QA is involved in many other important

support functions such as

Coordination and support to production, stores, QC etc.

Qualification of areas, equipment’s, facility etc.

Complaint handling and investigation

Validation activities i.e. Process Validation, cleaning validation, Non

Routine Etc.

Organizing and conducting self-inspection for current update and

compliances.

Change control and deviation handling procedures.

Issuance, control and storage of documents.

Batch release formalities.

Creation and approval of SOPs.


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Review of regulatory requirements and compliances.

Vendor validation and approval.

Creating Quality Awareness as per the cGMP requirements.

6.4.2 What Is GMP?

Good Manufacturing Practices (GMP) is that part of Quality Assurance which ensures

that the products are consistently manufactured and controlled for the purpose of their

intended use and therefore achieves zero defect products of assured quality and safe

for use. It covers all matters related to the quality and repeatedly ensures that the

quality is reproducible. It also fulfils the requirement of regulatory agencies around

the world.

6.4.2.1 What Is cGMP?

The “c” stands for “current” reminding us that we must employ technologies and

systems which are up to date in order to comply with the regulations.

6.4.2.2 Why cGMP?

Pharmaceutical industry is totally different from other industries for one very vital

reason that they deal with human life.

Hence the parameters of quality must be very stringent and thus they follow “Current

Good Manufacturing Practices”.

The way they do their jobs can affect the health of millions of people who use their

products.

6.4.2.3 What can happen if GMP is not followed?

A recall can involve calling back millions of units of a product

Every unit must be sent back to the plant

Every customer who has received a shipment from us may have to be notified.

A recall made can damage the good reputation.


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Recalls are harmful as it harms publicity which affects sales and in turn jobs.

The FDA has the authority to shut down our plant.

6.4.2.4 Basic elements of GMP:

Quality Management

Premises & Buildings

Equipment

Personnel

Materials

Production & Process control

Quality Control

Qualification & Validation

Documentation &Labeling

Sanitation & Hygiene

6.4.3 Quality Policy of Cipla:

The company is committed to ensure that every product it manufactures and

distributes, consistently meets with present standards of quality, purity, efficacy &

safety.

Excellence in products, processes and systems is to be achieved through the team

efforts of trained personnel of the company.

Implementation of quality policy is done through quality system based on cGMP in

conformity with national and international standards.


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6.4.4 Basic Sections in Quality Assurance:

6.4.5 Functions of Quality Assurance:

Ensure that active pharmaceutical products are designed and developed in a

way that takes account of the requirements of (GMP) and other associated

codes such as those of good laboratory practice (GLP) and good critical

practice (GCP).

Control of batch release: ensure that the pharmaceutical products are not sold

or supplied before the authorized persons have certified that each production

batch has been produced and controlled in accordance with the requirements

of marketing authorization and other regulations relevant to the production,

control and release of pharmaceutical products.

Responsible for the part of decision-making process in all matters that affect

the quality of products including development, production, laboratory, storage,

distribution, vendors and third party contractors.

Ensure that manufacturing processes is clearly defined, systematically

reviewed, and demonstrates consistency to predefined quality and

specification.

Monitoring of compliance with the requirements of cGMP and GMP

requirements of the country where the product is been exported.

Creating and authorizing quality systems, procedures and policies.


Quality Assurance

Quality Management

System

Batch Record Review and

ReleaseQA Observer Qualification

and Validation Regulatory

Affairs Training Laboratory QA

Goa

Control on access, issuance and withdrawal of authorized usage copy of all the

master documents to all concerned departments.

Generation, approval and issuance of batch documents, validation

protocols/reports, written procedures and control of soft and hard copies.

Establish and approve Master Batch Manufacturing and Master Packing

documents.

Retention and destruction of records.

Monitoring and control of manufacturing environment. Critically examining

the environment with a view to minimizing product contamination.

Interacting with product development and manufacturing personnel to validate

processes, procedures and methods.

Interacting with manufacturing and engineering personnel in planning for the

construction, alteration, renovation, or purchase of premises, plant or

equipment.

To check the maintenance of building, premises and equipment.

Perform annual reviews of all drug substances and drug products to assure that

quality standards are appropriate and being met.

Handling of rejection.

Control and monitor technology transfer activities.

To conduct the self-inspection and/ or quality audit that regularly appraises the

effectiveness and applicability of the quality assurance system.

Assure that appropriate calibration and preventive maintenance of

manufacturing equipment and laboratory instruments are conducted as

scheduled.

Designation and monitoring of storage condition for materials and products

Evaluate and approve/ reject any reprocessing and reworking of products.

Conducting unit operations.

Ensure pest control activities are done as per schedule.

Ensure conformance of activities with SOPs.

Ensure that all activities are carried out as per BMR/BPR.

Ensure on line, legible, correct and timely entries of all operations/ activities

and all entries have been done by competent persons on the batch documents.


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Timely review of different logs of production, packing, stores, quality control.

Ensure cleanliness of area.

Ensure availability of current and approved SOPs at the shop floor.

Ensure the correctness of status labels, labeling of

containers/equipment’s/glassware and materials in all the areas.

Monitoring of IPQC of dosage forms, process controls, online documentation

and observe deviations if any.

Checking of over printing of details and proof checking.

Providing line clearance.

Highlight abnormal wastage/ process timings of unit process.

Improving in-process control.

To control/ prepare & review documents required for registration, submission

etc.

Reviewing technical aspects of the contract or agreement with customers

(technical agreement).

Maintaining all regulatory documents.

Checking of expert orders for compliance with registration details and

coordination for necessary updating.

To fulfill the current needs of “Training” with respect to GMP, GLP, Safety &

hygiene.

Ensure that all staff is adequately trained for the procedures to be followed.

To ensure that the required initial and continuing training of personnel are

carried out.

Evaluation and approval of change controls and study of impact related to

changes.

Evaluate and investigate complains relating to product quality received from

any source.

Participate in the investigation of deviations.

Investigations of returned/ recalled products.

Investigation of analytical incidences, OOS/OOT and verifying its impact on

current as well as previous material/product.

Approval and monitoring of suppliers of material.


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To review the risk involved in any activity.

Monitoring laboratory activities in compliance to company procedure and

cGMP/cGLP regulation.

Ensure that all necessary testing is carried out.

Verification and approval of the laboratory test report received from quality

control in line with relevant specification/SOP.

To approve project starting material, packaging material, intermediates, bulk

and finished products.

Reviewing and changing specifications and test methods.

Approve specifications, sampling instructions, test methods and other quality

control procedures.

Ensure use of valid chemicals, standards, reagents, correct glassware

instruments/equipment’s and correct test methods are qualified and calibrated

for analysis.

Interacting, establishing &mentoring stability determination. Assure

availability of stability data to support retest or expiry dates and storage

conditions on drug substance, intermediates and drug products. Completion of

stability analysis as per scheduled intervals. Monitoring the stability chambers

and their maintenance schedule.

Software control in QC by monitoring of password control and revisions,

monitoring of backup of electronic data, monitoring of template control of

instruments, monitoring of software up gradation and validation and control of

print and re-issuance.

To approve and monitor any contract analysis.

6.4.6 STANDARD OPERATING PROCEDURE (SOP)

SOP is defined as logical sequence of events in instructional format how the

activities is to be carried out. SOPs are prepared by respective user

department, reviewed by department head and approved by unit Quality

Assurance Head. SOP should be made effective within 30 days after the date

of issue. All SOPs should be reviewed every 2 years or whenever applicable,

whichever is earlier.


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6.4.7 VALIDATION PROCESS

Validation process is a documented program which provides a high degree of

assurance that a specific process will consistently produce a product having

predetermined specifications and quality attributes.

The objective of validation is:

Quality, safety and effectiveness must be designed and built into the

product

Quality cannot be inspected or tested in the finished product.

Each step of the manufacturing process must be controlled to

maximize the probability that the finished product meets all quality

and designed specifications.

Types of validation:

Prospective validation is done for the introduction of new

drug products and their manufacturing process. The objective

is to prove that the process will work in the accordance with

validation protocol prepared for the pilot production trials-

initial 3 batches.

Concurrent validation is done for existing process.

Retrospective validation it is a historical trending. Validation

after production, generally through the statistical treatment of

data collected during production trials.

Revalidation means Re-performance of all or part of the

validation periodically or whenever major changes occurs.


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6.5 QUALITY CONTROL DEPARTMENT

6.5.1 Objectives

The objective of Quality Control is to ensure that all the products manufactured in the

company are analysed as per their specifications, leading to meet the desired quality

standards of marketing authorization such that the delivered products will fit for their

intended use and will help in maintaining and improving patients health.

6.5.2 Functions

Functions of a Quality controller:

Sampling, testing and release of raw material, packaging material and finished

product.

To carry out the stability study of finished product to ensure the products

manufactured are stable till its shelf life.

Maintenance and calibration of instruments/ equipment’s.

To ensure the Good Laboratory Practices (GLP) are followed at each level of

Quality Control activity.

To carry out the method validation for the tests carried out to ensure the

quality of the product.

Preparation and updating of specification/standard of raw material, packaging

material and finished product.

6.5.3 Role of Quality Control in Raw Material Section

Raw Material is any ingredient intended for use in the production of

intermediate or APIs. These may include starting materials, process aids,

solvents and reagents.

The Raw Materials consists:

o Active Pharmaceutical Ingredients (API):

An API is any substance or mixture of substances intended to be used

in a manufacture of a drug (medicinal) product and that,when used in


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the production of the drug, becomes an active ingredient of the drug

product.

o Excipients:

Any ingredient other than the drug substance used in the

manufacturing of drug product. It may be a preservative, colouring

agent, sweeting agent, flavouring agent etc.

After the receipt of intimation of Goods Received Note (GRN) from the

stores, acceptance and registration of intimation is done by allocating the

Analytical Reference Number (A.R.No). A.R.No is the unique identity for the

particular material.

Sampling analyst performs the sampling activity and affix under test labels to

the containers.

Analysis and reporting is done as per the respective specification.

After completion of analysis completed report is submitted for review to the

section head/ reviewer.

Head QC counter checks the report and approve/ reject the material

accordingly.

The approved report along with the status label (PASSED/ REEJECTED) is

submitted to Lab QA for verification.

Once the report is reviewed and verified by Lab QA the status labels are

handed over back to section head whereas the custody of Lab QA.

The status labels (PASSED/ REJECTED) are affixed on the containers by QC.

6.5.4 Role of Quality Control in packing material section

A) Primary Packaging Materials:

Packaging material which is in direct contact with the product such as

foils, PVC films, vial, stopper or which maintains the integrity of the

product such as aluminum seal or which may come in direct contact of the

product in future at user end and packed with the product such as droppers,

syringe, measuring cups etc.

B) Secondary Packaging Materials:


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Packaging materials which is in direct contact with the primary packaging

material, e.g.: carton, leaflets.

C) Tertiary Packaging Materials:

Packaging material which is in direct contact with the secondary

packaging material, e.g. shipper, pp. strap refers to tertiary packaging

material.

Flow of Raw Materials:


RECEIPT OF INTIMATION AS GRN

ALLOCATION OF A.R.NO.

SAMPLING

AFFIX UNDER TEST LABLES TO THE CONTAINERS

ANALYSIS AND REPORTING AS PER

THE RESPECTIVE SPECIFICATION

REVIEW OF RAW DATA AS PER

SPECIFICATION

APPROVAL OF REPORT BY HEAD QC

VERIFICATION OF REPORT BY

LABORATORY QA

AFFIX STATUS LABELS (PASSED/

REJECTED) TO THE CONTAINERS

MATERIAL READY FOR PACKAGING

Goa

6.6 FINANCE DEPARTMENT

6.6.1 Roles of the Finance Department

Payment of various accounts, but only those payments that are to be made in

India.

Dealing with the monthly/ yearly statutory payments.

Analysis of expenditure and making the presentation of the same to the

management.

Handling of audits like Statutory Audit and Internal Audit.

Budgets are prepared and in case of any deviation i.e. overutilization or

underutilization are being explained.

It also deals with Petty cash.

6.6.2 Flow of Inventory Management System (IMS):


PLANNING DEPARTMENT GIVES

THE PRODUCTION PLAN.

STORES DEPARTMENT WILL RAISE INDENT FOR

RAW MATERIAL/ PACKING MATERIAL.

PURCHASE DEPARTMENT WILL

PLACE ORDER.

MATERIAL IS RECEIVED AT STORES WITH GATE-

ENTRY.

GOODS RECEIPT NOTE (GRN) IS PREPARED BY STORES DEPARTMENT.

MATERIAL IS ANALYSED BY QC DEPARTMENT.

GRN'S ARE IMPORTED THROUGH SYSTEM IN

ACCOUNTS.

PAYMENT IS RELEASED FOR PASSED GRN'S AS PER PURCHASE ORDER

TERMS.

Goa

6.6.3 Flow of Capital Expenditure Requisition (CER)

6.6.4 Miscellaneous material

User Department raises indent which is approved by Department Head & Unit

Head.

Purchase Department Places order.

Material is received at stores with gate entry on challan.

Material is received by user department who will take approval of Department

Head.

Miscellaneous GRN’s are imported in system.

Payment is released as per Purchase Order terms.


Payment is released as per Purchase Order terms after receiving installation report.

Challans will be received at Accounts Department.

Material/ job is received/ completed and approved at user Department.

Purchase Department will raise order.

CER will be approved by respective Department Head, Safety, Accounts & Unit Head. Accounts Department gives AC. code.

CER is raised by the user Department.

Goa

6.6.5 Work order

Work Requisition is raised by User Department.

Approved by Unit Head.

Work Order is generated.

Work is completed.

Payment is done as per Work Order.

The cost of Work Order should not exceed Rs.10,000.00.

6.6.6 Statutory payments

These payments to be paid to Govt. of India in each month on fixed date.

Tax Deducted at Source (TDS).

Provident Fund (PF)

Employees State Insurance Corporation (ESIC).

Excise Tax, Entry Tax, VAT/CST, Service Tax, Work Contract

Tax (WCT).

4.6.6 Employees Payment

Salary- Cipla has ICICI bank facility- By the end of the month, the

salary amount gets credited to individual employees account.

Leave Travel Allowance (LTA) - it is paid for the period April to

March. Leave is to be registered in Cipla Attendance System for 5

days. The same should get approved by the Department Heads.

Personnel Department sends LTA calculation notes to Finance

Department. Finance Department then cross checks the same. The

total amount then gets credited to the employees ICICI Account.

Settlement-Personnel Department rotate NOC notes to ex-

employees Department & Unit. Accounts Department verifies the

Income Tax, 10U & forwards the same to Personnel Department.


Goa

The same get cleared on Tuesday & Friday inform of cheque as per

original Stamp Receipt duly signed by ex-employees.

IOU (I OWE YOU)- It is an advance paid to employees for official

tour or visit purpose. It has to be settled within 48 hours after visit.

6.6.8 Financial Audit:

Internal Audit- it is held in four quarters:

April to June

July to September

October to December

January to March

Statutory Audit- It is held after half yearly & yearly closing.


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6.7 HUMAN RESOURCE DEPARTMENT

Organizational chart

The role of HR department is very vast which covers Security, First Aid, Recruitment

& Appointment, Intranet Attendance System & Leave Application, Entry and Exit of

visitors at main entrance, Performance Review for Trainee/ Probationer staff and their

confirmation, Final Settlement etc.

6.7.1 ROLE OF HR IN HANDLING SECURITY

Security personnel shall act to watch and guard the company’s premises,

property and the personnel and to protect from theft or pilferage, sabotage and

fire.

Security personnel shall be available round the clock for duty in requisite

numbers on the gate and other check points.


MA

NA

GIN

G D

IRE

CT

OR

TECHNICAL DIRECTOR

SENIOR FACTORY

MANAGEMENT

HR ( GOA 1& 3)

TRAINING & DEVELOPMENT

PAYROLL

SECURITY

HR FUNCTIONS

HR (GOA 2)

HR FUNCTIONS & PAYROLL

SECURITYHOSPITALITY /CORPORATE

SOCIAL RESPOSIBILITY

Goa

All personnel shall be trained in usage of fire extinguisher and other

firefighting equipment and the fire hydrant system.

They shall check and record the details of material coming inside the premises

in prescribed log book.

They shall provide appropriate checks and controls on the material going

outside and ensure that the material going outside and ensure that the material

is going out with appropriate gate pass with signature of authorized signatory.

They shall ensure that no person is entering the premises without reason and

permission.

All personnel entering the premises shall be instructed about the safety needs

of the company and they shall not be allowed to enter unless they dispense all

smoking and objectionable material at the gate.

All security personnel shall be trained in First Aid and they shall be capable to

provide first Aid whenever required.

6.7.2 RECRUITMENT AND APPOINTMENT OF PERSONNEL

As and when the vacancy arises and /or based on the feedback from the

department requiring manpower, the manpower shall be reviewed and

compared with approved budgeted manpower by the respective Department

Head and the HR Department. Department Head shall raise

Manpower .Requisition Form as per annexure, get it approved by Unit Head

(in case of replacement) or Site Head (in case of manpower over and above

approved budgeted manpower) and submit to HR Department.

HR Department shall be responsible for sourcing the candidate either from the

data bank being maintained by them or raising the advertisement in suitable

media.

The advertisement shall specify the location of vacancy, desired qualification

and experience, age and other information as deemed required for the vacancy.

Minimum qualification for recruitment in various departments are annexed in

the SOP of HR Department.


Goa

The application shall be collected, reviewed and based on the merit as well as

the specified criteria; potential candidates shall be short listed and called for

the interview. This shall be communicated to the candidates.

The interviews shall be conducted by a panel nominated by the unit head.

The selection of the candidates shall be based on the qualification, knowledge,

age, experience and safety awareness as well as on the performance of the

candidate in the interview and /or written exam (if applicable).

The candidates selection shall also be subject to proof of the authenticity of

the documents provided by the candidate.

The Unit Head shall finally approve the recruitments. Authority to finally

select the candidate shall rest with the Unit Head.

HR Department shall check and confirm the background of the candidate by

checking with other possible sources.

The selected candidate shall be subjected to medical examination.

After passing the medical test the candidate shall be appointed and inducted.

Incase if anyone has requested for a transfer to any unit/ location where

vacancy exists or if the management decides to transfer anyone for the said

vacancy, the HR Department can proceed with the employees transfer/

absorption as per the following procedure:

Transfer of employment can be affected to anyone’s service by two ways:

I. A written request from the employee to management seeking transfer

of employment clearly mentioning the unit and location.

II. If the management feels the requirement of an employee at another

unit or location.

In case of written request from the employee:

Concerned Department Head accepts the application and at his

discretion may accept or reject his request.

If accepted, the application is forwarded for Unit Heads

approval and then to HR Department

HR Department in turn finds out whether suitable opening are

available at the unit/ location preferred by the employee and if


Goa

available the application is forwarded to Head Office HR

approval.

Once approved from HO HR,unit personnel along with the

personnel from unit /location where transfer is requested

mutually agrees for a date for absorption / transfer.

Incase the transfer requested is to the same unit / location, then

the unit HR Depart. Issues a transfer letter to the concerned

employee and his personnel file will be transferred to the unit /

location. All the unavailed earned leave, gratuity etc. shall be

carried forward to the new unit/ location.

In case of management decision:

If the management feels the requirement of its employees

expertise to be utilized at a new unit / location, the following

procedure is followed.

Identify the unit/location where in the expert employee is

available.

Take consent from concerned Department Head and get it

approved from Unit Head and HR Department

HR Departmentthen sends the paper to HO HR for approval.

Once approved from HO HR, Unit HR Department initiates

action to transfer the employee as per SOP’s.

6.7.3 INTRANET ATTENDANCE SYSTEM AND LEAVE

APPLICATION

The purpose is to provide a procedure for attendance and leave application

through intranet for employees. It is applicable to all management staff on roll

of Goa establishment.

Employee shall access attendance through intranet attendance system and

leave application by using any web browser and use address for Cipla I, II, and

III.

Select the location, login the user id and password.


Goa

On the main menu, select the desired menu. Description is mentioned against

each menu.

Time Card – employee can view their attendance.

Irregular communication details – employee can view their single swipes or

absenteeism details.

Leave Application – employee can apply their leave and on duty applications.

Cancellation of leave application – employee can cancel leaves before it gets

sanctioned from HOD.

Cancellation of rejected application – when HOD rejects the leave applied by

employee, it appears in this menu and then employee shall cancel the leave.

Exception application - employee can update their single swipes in this menu

and then HOD sanctions it.

Holiday list – annual holiday list for calendar year is displayed.

Weekly and monthly updation – HOD can update shift of all employees

reporting to him.

6.7.4 PERFORMANCE REVIEW FOR TRAINEE/

PROBATIONER STAFF AND THEIR CONFIRMATION

The purpose is to provide overall procedure for periodically assessing the

performance of employees joined on rolls of the company as trainee or as a

probationer. It is applicable to all new joinees on rolls of the company.

Performances of new joinees are reviewed periodically in a prescribed format

by their Department Heads. The performance of trainees is assessed on bi-

monthly basis. Forms of concerned employees are handed over to the HOD’s

by personnel Department in advance. The filled review forms duly signed by

HOD and Unit Head are sent back to HR Department and are kept in the

personal file for records.

This assessment plays an important role in deciding the continuation of trainee

/ probationer in the company. Employees successfully completed their training


Goa

/probation period are confirmed on the rolls of the company based on a formal

recommendation received from HOD duly approved by Unit Head. Employee

will be issued a formal letter on letter head informing them about their

confirmation on the rolls of the company.

6.7.5 Employee self- service

The purpose is to provide a procedure for operating Employee Self Service

system at various units through intranet. It is applicable to all employees on

the rolls of the company.

Employees of various units can access the system through intranet by typing

address on any web browser. The employees can view their salary structure

i.e. Cost to Company (CTC) and current salary structure. Employee reports

help to view pay slips up to previous two years. PF statement and Form 16 can

also be viewed and edited like address, mobile number etc. in case of any help

a help desk is also there to provide any feedback, suggestion can be given and

calendar can be seen and also FAQ’s.

6.7.6 Attendance system for employees engaged through service

providers

The purpose is to provide a procedure for the system for registering daily

attendance through biometric attendance system for employees working with

Cipla through service providers. It is applicable to all employees working with

Cipla through service providers.

Daily Attendance Registration:

Every employee shall record their attendance twice a day by placing the finger

on biometric attendance machine available in the facility during entry and exit.

Every employee shall confirm that their attendance is recorded by the

machine by viewing their “Employee Number” on the screen followed

by an audio “Thank you” from the machine.


Goa

In case if the machine responds “Please try again” then the employee

has to place the finger again and ensure that the attendance is recorded.

Even after repeated attempts, if the machine does not accept the finger

then same shall be reported to concern Department Head for

regularizing the attendance.

Employee shall contact the supervisor for viewing / verification of

attendance.

FINGER PRINT REGISTRATION:

A unique “Employee Number” shall be allotted on which daily attendance

shall be registered. Every employee’s finger print shall be registered on the

day of their joining.


Goa

6.8 CORPORATE SOCIAL RESPONSIBILITY DEPARTMENT

‘Caring for life’ has been the forefront business philosophy, and remains the principal

purpose of doing business at Cipla. This philosophy is seamlessly integrated into

Cipla’s people, products and processes.

Being a pioneer in the sector, they remain committed to their philosophy in an ever

changing eco-political environment. Their corporate responsibility policies and

practices are committed to achieve the goals of sustainable development by

integrating economic, environmental and social imperatives. They comply in full with

the laws and regulations in each country where they operate. In addition, they operate

in accordance with Cipla’s corporate responsibility framework, aspiring to achieve the

highest international standards regardless of location and without exception.

6.8.1 Policy Statement

“We strive to be an admired & trusted Company by conducting their business

ethically in a socially and environmentally responsible manner.”

CR Policy Framework

The corporate responsibility vision of Cipla is to achieve the distinction of being

acknowledged as an admirable and trusted Company. Sustainable development and

creating value for the stakeholders are two missions that will drive the company to

realize its corporate responsibility vision which will be built on their strategic pillars

of the corporate responsibility framework – ‘safe & quality products at affordable

cost’, ‘valuing their people’, ‘helping the environment & sustainability’ and

‘empolying their communities’


Goa

6.8.2 Purpose of the Policy

The purpose of their Corporate Responsibility policy is to make clear to all

stakeholders their approach to corporate responsibility and to outline how they

propose to meet the challenges of sustainable development. They reflect this

commitment in a range of policies set within the ‘framework’ around five areas of the

business influence:

1. Marketplace

2. Workplace

3. Community

4. Environment

5. Operational Management


Goa

6.8.3 Corporate Responsibility Principles

They are committed to following corporate responsibility principles:

1. They manage their business with integrity.

2. They are committed to compliance with law in all that they do.

3. They aim to provide a safe, fulfilling and rewarding career to all their employees.

4. They actively assess and manage the environmental impacts of all their operations.

5. They will continually benchmark and evaluate what they do in order to improve

their performance.

6.8.4 CR Commitments

Their corporate responsibility policy outlines the company's specific commitments.

They see it as both a reflection of their current sustainability performance and

roadmap & vision for their future progress.

6.8.4.1 Ethical Business

“They uphold the highest standards of their business conduct by way of meeting all

ethical, legal, regulatory and governance standards.”

In order to remain an industry leader, they

1. Continue to comply with all applicable legal, regulatory and ethical standards.

2. Carry on their legacy to provide patients and physicians with a service hallmarked

by integrity, quality and care.

3. Continue to deal with complaints seriously and promptly.

4. Never make any improper payments (whether or not legal or customary).

5. Will not make donations or contributions for political causes.

6. Engage and communicate transparently with all key stakeholders to understand

their concerns and expectations.

7. Remain accountable for improving the quality of their disclosures to investors,

shareholders and other stakeholders.

8. Use Business Responsibility Report/ Sustainability Report as a means to engage

and respond to the aspirations of their stakeholders.


Goa

6.8.4.2 Customers

Cipla upholds its commitment to make products accessible at an affordable price.

To achieve it, they

1. Carry on their endeavour to produce safe and quality drugs.

2. Continue to manufacture a wide spectrum of products that are affordable and

accessible.

3. Continue to manufacture special drugs for rare or orphan diseases.

4. Continue to deal with customers in a professional manner and maintain the highest

standards of integrity and honesty.

6.8.4.3 Supply Chain

They remain committed to pursuing ethical and responsible supplying of goods and

services, and work with organizations that value their principles and aspirations.

In remaining adhered to their policy, they

1. Ensure that their suppliers also meet some of the business fundamentals such as

adherence to laws/acts/regulations etc.

2. Continue to engage with suppliers to help them understand their expectations from

them on the ‘right conduct’ of the business with us.

3. Hold periodical trainings/workshops for suppliers to improve responsible practices.

4. Reward suppliers for improved practices; similarly, take action by terminating the

contract for unethical practices.

6.8.4.4 Research & Development

“They uphold their commitment to discover path breaking scientific innovations that

eventually yield safe, affordable and sustainable product solutions.”

In pursuit of R&D excellence, they

1. Will remain tuned to the Company’s philosophy, “Caring for Life”.

2. Follow the highest ethical standards while carrying out pharmaceutical research.

3. Undertake clinical trials ethically and responsibly.

4. Remain committed to developing new and innovative pharmaceutical solutions.

5. Develop pioneering research opportunities with leading scientific and academic

institutions.


Goa

6.8.4.5 Employees

“We affirm our commitment to relentlessly work to achieve the distinction of being

employer of choice.”

To achieve this excellence, they

1. Continue to comply with the relevant labour laws, standards and guidelines.

2. Adopt a transparent process of recruitment and selection of talents, career planning,

promotion, training, transfer and personal development.

3. Carry on their commitment to ‘Zero-tolerance’ to any form of workplace

discrimination, bullying, harassment or physical assault and provide a fair and non-

discriminatory employee grievance system.

4. Continue to value diversity and treat all employees fairly, providing equal

opportunity at all levels of the organization without any bias.

5. Ensure that employees from all religion, caste, creed, cultures and nationalities are

respected.

6. Remain adhered to their commitment to refuse to employ children in their work and

also shall not associate with suppliers, partners or associates who are found to engage

children in work.

7. Uphold the right of employees to freedom of association and collective bargaining.

6.8.4.6 Health & Safety (H&S)

“We are committed to set and meet the high (est) standards of Health & Safety.”

In order to achieve it, they remain committed to

1. Nurture and uphold a corporate culture that is aware of, and values H&S.

2. Keep identifying and mitigating potential H&S risks.

3. Strengthen further and implement a safe work system and occupational health

processes & procedures.

4. Put in place accountability, training, and systems to ensure appropriate Health &

Safety management at all levels of the Company.

5. Conduct effective communications with contractors, suppliers and business

partners to ensure H&S standards & priorities of the Company are understood and

respected.

6. Be prepared to respond quickly to any emergencies.


Goa

6.8.4.7 Human Rights

“We pledge to respect, promote and strengthen human rights.”

To uphold the human rights commitment, they at Cipla shall continue to

1. Adhere to the principles of Indian Constitution and all the relevant

laws/Act/guidelines of the country as well as of all those countries/regions in which

they operate their business.

2. Treat people in equal and fair manner regardless of their ethnic origin, nationality,

religion, caste, creed, sex or age.

3. Encourage their employees to value diversity and different cultures.

4. Avoid any form of discrimination.

5. Say ‘no’ to Child labour in their workplace and in supply chain too.

6. Work in communities to help them realize their rights to health, education and

livelihood etc.

6.8.4.8 Environment

“We shall embrace the improved environmental practices so as to have continual

improvement in the environmental footprint of our business.”

To achieve this, they

1. Continue to comply with all relevant laws and regulations, and strive to meet the

leading global standards.

2. Continually improve the efficiency and optimize the use of raw materials, energy

and natural resources.

3. Continue to adopt and integrate ‘Reduce’, ‘Reuse’ and ‘Recycle’ principle in their

work.

4. Continue to reduce harmful emissions to air, water and land.

5. Carry on their commitment to minimize wastes and the toxicity of wastes.

6. Periodically conduct environmental impact assessment and risk assessments, and

take appropriate actions.

4.8.13 Sustainable & Resilient Community

“We shall strive to be a good corporate citizen.”


Goa

In order to develop a sustainable and resilient community in which they operate their

business, they

1. Identify the communities and other stakeholders associated with their operations

and actively engage with them, and shall help the community to help themselves with

financial, human and products resources.

2. Design and develop needs based ‘Social Development Plan’ and ‘Implementation

Strategies’ which meet the expectations and aspirations of communities as well as

meet the country development goals and Millennium Development Goals (MDGs) in

its spheres of influence.

3. Continue to recognize and respect diverse culture, interests and rights of local

communities.

4. Continue to promote and build partnership with NGOs towards implementation of

their Social Development Plan.

5. Carry out periodical studies, evaluation and social audits to measure impact of

programs and projects and changing aspirations of communities.

6. Supplement and strengthen those governmental schemes which are in alignment of

their corporate responsibility objectives and are done in their areas of operations.

7. Continually encourage and facilitate employees to contribute to society and

environment development.

6.8.5 Corporate Responsibility Organization Structure

A CSR Committee comprising three or more Directors, including an independent

director, will be formed. The CSR Committee will set directions for

CSR/Sustainability, and will own up the overall responsibility. However, the

Committee for the effective planning and implementation may constitute a high level

Executive Council, which will include heads of relevant functions, corporate staff and

Head –CSR/Sustainability as the Member Secretary.

Cipla has established a Corporate CSR/Sustainability Office to support the CSR

Committee and drive the execution process.

The main tasks of the office are:

1. Trend analysis.

2. Development of strategy, policy and action program development.


Goa

3. Development of operational guidelines and oversee whole gamut of the plan

implementation.

4. Monitoring and reporting, including publishing the annual sustainability

performance results.

5. Functional leadership of the sustainability network in sectors, functions and

cluster/countries.

6.8.6 CSR ACTIVITIES CARRIED OUT IN GOA:

MERIT INCENTIVE SCHEMEUnder this scheme scholarships are given to five rank holders who have passed SSC. It is given to 20 schools located at around 15 KMS radius of the company.

PASS INITIATIVEThis scheme is put forward to help the slow learners especially the girl child. They are given remedial classes for two hours every day. It also helps in employing the unemployed educated youth.

PROJECTS ON SANITATION BLOCK UPGRADATION It has been taken up in those schools which lack sanitation facilities and this scheme has been followed since 2010.

RAIN WATER HARVESTING PIT Various schools are being educated in the above context.

NETRADEEP EYE CHECK CAMPThis is being carried out in association with Mukta opticals, Goa Medical College and Indian Medical College. Here the eye check-up is done for free and also medicines are distributed. It mainly focuses on the middle and old aged people.

BAL NETRA SURAKSHASchools in two talukas which cover over sixteen thousand students fall under this scheme. Eye check-up are done to prevent further complications.

SELF DEFENCEClasses are given to those 50 women who are interested for 2days.

WORLD ENVIRONMENT DAY Tree plantation drives are carried out along the highways, clean-ship drives and education on Hands on Organic kitchen gardening are being carried out.


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7.1 SWOT ANALYSIS

7.1.1 Strengths

Cipla has developed good positive image by providing support to cancer

patients by issuing drugs at low cost.

Imminent commencement of the Fixed-Dose combination for treatment of

uncomplicated P. falciparum malaria to tackle the 200+ million cases of

malaria globally.

Best in the business Research and Development facility.

Cipla trains its employees through Skill Development Programs for a period of

two years therefore it has a very good pool of skilled manpower of over

16,000.

Initiation of ‘No Touch Breast Scan’ a step forward in the screening

technology in India.

A foremost player in anti-infective and anti-asthmatic formulations.

7.1.2 Weakness

Operational pace is relatively slow due to import time taken for primary and

secondary goods that are needed for the production process.

Panel members of the interview come late as a result the candidates have to be

kept waiting.

Manual checking of employees is done at the entry exits of the company.

Job Descriptions are not assigned to employees hence they do not have a clear

mind set on what are their roles and duties.

Strong competition from international and domestic giants therefore it is able

to capture only limited market share.

Cipla had faced problems during negative campaign by AHF (AIDS

Healthcare Foundation)


Goa

Accommodation is not provided to those candidates who come for interview

from different states.

7.1.3 Opportunities

Quick and cost effective adaptation of product to market requirement of Indian

market.

With the new government and its policies and campaigns of Make in India

there is a wide scope for company to set up its manufacturing units.

The growth in research and technology in all industries in the country will

help Cipla to adopt faster and easier ways to carry out its production..

Increased investment in the budding markets will help Cipla to push expansion

in the global economy even further.

The growth of medical tourism in India will boost the manufacturing and sales

of products of Cipla.

7.1.4 Threats

Economic Slowdown may result in shutting down some of its manufacturing

units.

Inflation leading to rise in cost of raw materials and labor as a result it might

have to increase prices of its products and salaries of its employees.

Cipla faces Strong competition in all the product line of from international as

well as other domestic companies.

Due to Imported machines there is lack of knowledge about its usage and

therefore problem in handling machine breakdowns.

Fluctuations in currency exchange rates have a noteworthy impact on the

Company’s operations and financial results.


Goa

8.1 SUMMARY OF FINDINGS:

Cipla is world’s largest generic pharmaceutical companies with a strong

presence in over 180 countries.

In Cipla there were departments like Production, Packing, Stores, Quality

Assurance, Quality Control, Finance, Human Resource and CSR.

The company follows a functional organizational structure and has an open

organizational culture.

Policies and procedures followed are transparent and satisfactory.

Adherence to high quality standards and safety policy.

Conducive work atmosphere.

Environmental and Quality standards with awards for recognition.

Updated technology and concepts.

Entire functioning of the organization is well coordinated through SAP software

and SAMBANDH a company’s website where it gives employees different

details like salary, leaves taken etc.

Training and development programs conducted as per the needs.

They have well trained employees to every job position in the company, be it

Production, HR, QC, QA etc.

Cipla has facilities to improve the job satisfaction indirectly by providing

Transport facilities, food facilities etc.

Cipla premises are big enough to accommodate all the processes efficiently.

The entire inventory management is computerized.

The company has satisfied employees and customers with its effective

medicines helping them to cure various diseases.


Goa

9.1 CONCLUSION

Cipla maintains a global standard across all its products and services. It has the

technological prowess to manufacture products in most dosage forms across various

therapeutic categories, thus giving the company a unique advantage. There are

different departments like Production, Packing, Stores, Quality Assurance, Quality

Control, Finance and Human Resource. It has different product lines which include

tablets, syrup’s, inhalers, capsules etc. Its R&D centres, primarily focused on

developing innovative products and drug delivery systems, have given the country

and the world many firsts.

Cipla is a highly research and development oriented organization which offers to its

customers futuristic technology which can help its customers in developing

technology. Its dedication to quality and with the support of committed work force, it

sure can become the market leader in all its products.

The company being located in Verna Industrial Estate has benefited the company due

to the closeness to various factors of production. The zone is uncongested and well

connected to the city, airport and National Highways.

Recently Cipla has been planning for an expansion by open a manufacturing plant in

Iran. Also, it has collaborated with Teva Pharma to sell drugs in South Africa.

Cipla’ success has continued making it one of the world’s largest standalone generic

pharmaceutical companies which has a presence in over 180 countries. Its 2000-

strong product-range. And with its Values, Focus, and Efficiency it will definitely

move on to conquer the industry by providing its medicine products and making the

world healthier place.


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10.1 SUGESSTIONS

Accommodation should be built for those who come for interviews as

sometimes they have to stay back for the next round of interview.

Panel members of the interview should be on time to avoid delays.

Metal detectors should be placed on each of the entry exits as of now only

manual checking is done.

Proper Job Descriptions should be given to all employees so that the

employees have a clear mind set on what are their roles and duties.

Shorter time should be taken is selection of candidates.

Motivation should be provided to employees by giving them small gifts and

goodies.

Work timings should be changed from 8.30 am – 5.00 pm to 9.00 am to 5.30

pm.

Import time taken for goods could be reduced by placing the order of materials

well in advance at least 6 months.

Better Engineering method could be used in the Production, Stores, Packing

for manufacturing and movement of goods thus help in saving time.

Dress code should be given to employees who work in the administrative

department.


Body of the project

Education

detailed study

course of study

interpretation of study

study critical analysis

different departments

data collection

types of secondary data

certain departments