Jawaharlal Nehru Pharma City (Developed by Ramky Group and APIIC) Parawada, Vishakhapatnam District A Sector Specific Industrial Park for Bulk Drug, Pharmaceuticals.

PHARMA INDUSTRY – EMERGING CHALLENGES AND OPPORTUNITIES

Jawaharlal Nehru Pharma City(Developed by Ramky Group and APIIC)

Parawada, Vishakhapatnam DistrictA Sector Specific Industrial Park for Bulk Drug, Pharmaceuticals & Fine Chemicals.

Government of AP initiative under Public Private Partnershipon Build Own Operate (BOO) basis

Dr P.P. Lal KrishnaChief Executive Officer

Ramky Pharma City (India) Ltd

Agenda

Pharma industry overview

Opportunities for Indian pharma

Regulatory Approvals

Jawaharlal Nehru Pharma-city – An overview

Need for Incubators

Cluster Development Approach

Role of Cost Accountants in Pharma Industry

Conclusion

Started its journey in 1903 when professor D.C Roy forward Bengal chemical

and pharma clinical works in Kolkata.

During half of the 20th century, Indian government largely dependent on the UK,

France and Germany for medicine.

The new and independent government in 1947 Emphasized on Industrialization

to achieve self reliance and therefore invested heavily in pharmaceuticals

among other industries and reduced import of medicines

The government takes its first concrete steps towards self reliance in

pharmaceutical sector in 1954 with the establishment of Hindustan antibiotics

ltd (HAL) and in 1961 establishing Indian Drug and Pharmaceutical Limited

History of Pharma sector in India:-

It’s a $ 20 bn industry divided almost equally between domestic and exports

Growing at a healthy 2 digit rate Poised to touch $ 40 bn by 2015 Already emerged as a “preferred” sourcing hub for the global

fraternity One of the mature markets Almost 98% drugs are made locally

Indian Pharma Today

Good balance between MNCs and Indian companies

Becoming leader in Generic formulations Reasonably strong in APIs too A truly global presence

Indian Pharma Today

Opportunities for Indian Pharma Generic Opportunity: 450 molecules worth USD350bn are going off-

patent in the coming years (Source: McKinsey)

The contract manufacturing opportunity of prescription drugs is estimated to increase from a value of USD26.2 billion to USD43.9 bn. in the next 5 years.

There are many important categories such as monoclonal antibodies, peptides, biotech, etc., which are not filed by India forgoing a global opportunity of appx.USD90bn.

Several technologies such as sustained release/controlled/modified release Lyophilized Pharmaceuticals, bio-pharmaceuticals, Specialty generics, Drug Intermediates, NIP based APIs/Formulations, regulatory compliant infrastructure are not attempted in India. There are more than 285 drugs in this category with an opportunity of USD50bn.

In the drug research value chain, there are certain key strengths such as: Significant valid population to participate in clinical trials Significant capabilities in medical skills, hospital beds and IT.

There exists an opportunity to capture the market share in global clinical R&D market such as clinical trials, data management, testing etc.

By 2012, nearly half of all newly approved prescription drug products will be biologics.

Opportunities for Indian Pharma

Regulatory ApprovalsAuthority Name of Regulatory Agency Nos.

USA

DMFs filed with U.S. FDA (companies) (As on Sept 2012) 225

No: of Sites(Bulk drugs + Formulations) Approved by US FDA (as on 30th Sept 2013) 390

Total No Of DMF’s (Type II Active) Filed from India (as on 30 th Dec 2013) 3411

ANDAs(As on 31st Dec 2013) 2661Formulation companies with USFDA approvals. 32

EUROPE

Number of CEPs received (as of 31st Jan 2014) 1105

Number of companies with CEPs 155

Number of Molecules for which CEPs have been filed with EDQM 344

No of Sites approved by EDQM In India(As on 30th April 2013) 353

UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as March 2013 1110

Number of CEPs with Irish Medicines Board 300Number of companies registered in Irish Medicines Board 19

number of Authorisations with Sweden MPA (Läkemedelsverket) 209

Number of companies having MA`s with Sweden MPA (Läkemedelsverket) 14

WHO GMP WHO GMP Certified Plants (as per Drug Controller General of India) 1270 (approx.)

Ethiopia DACA (Drug Administration and Control Authority), Ethiopia (companies) 50

Tanzania (TFDA) Tanzania Food and Drugs Authority (companies) 1373

Need of the hour

Pharma infrastructure which allows the manufacturers to

focus only on producing and marketing the products in a

seamless way without having to worry about many corollary

issues like pollution, effluents, testing labs, BioE labs , logistics

etc.

Bridging the Gap Jawaharlal Nehru Pharma City - Sector Specific Industrial Park for

Pharma companies Developed by Ramky Group & APIIC has been promoted in order to bridge this gap.

Offering a world-class facilities, in a convenient city with all essential services for the pharmaceutical companies which will help them save on investments also

Jawaharlal Nehru Pharma City

World Class Facility

Fiscal Benefits of locating in an SEZ

JNPC- excellent pedigree

JNPC is the brainchild of Ramky group- a leading name in

Infrastructure space

Ramky is a 17 yr old, $ 2 bn, 6000+ employee group today

with Presence in India, UAE, Africa and Singapore

With presence in infrastructure, Environmental engineering,

Real estate, other allied industries

Jawaharlal Nehru Pharma City – Layout Plan

Salient Features of JN Pharma City JNPC offers world-class common infrastructure, common utilities &

basic amenities. Power with dedicated sub-station – 132/33/11 KV with backup feeder Dedicated Water supply scheme of 20MLD and summer storage tank in

an extent of 250 Acres Two Lane well paved Road network of 32 Km Street lighting with underground cabling Common Effluent Treatment Plant of 12 MLD Capacity Hazardous Waste Management Facility-6 Lakh Ton Capacity Marine Outfall Pipeline for disposal of treated effluents of length 16

Km onshore & 1.8 Km off shore with a diffuser depth of 18m Planning for Exclusive Township close to JN Pharma City

Plug-n-Play Facility

Effluent & Storm water Conveyance A dedicated 1000 Line telephone exchange with Broadband internet

connectivity Central Fire Protection services Common security & surveillance Planning for Logistics hub, Chemical Feedstock, Container terminals &

Common Warehouse facility Amenities include Banks, ATM’s, Primary health centre, food courts &

Club house etc… Exclusive pharma R&D center

Environmental Infrastructure

Effluent Conveyance Pipelines – 64 Km. Common Effluent Treatment Plant Marine Outfall Pipeline Hazardous Waste Management Facility Common solvent recovery area

Common Effluent Treatment Plant at JNPCSalient Features: Capacity : 12 MLD Separate Low TDS & High TDS effluent conveyance Pipe Line Network. Air Strippers for removal of Volatile Organic Compounds Incinerator / regenerative thermal Oxidiser for destruction of Volatile

Organic Compounds Fully automated Cyclic Biological Activated Sludge Treatment Plant Separate Treatment for Cyanides, Heavy Metals & other wastes. Multiple Effect Evaporators for High TDS effluent treatment Powdered activated carbon treatment Guard ponds for toxicity check Marine Outfall Pipelines - disposal of treated effluents

Project Background

Off shore Pharma Units

Effluent Collection

CETP (12 MLD) Diffuser - 15 Mt.

Marine Out fall

Incinerator

Amenities & Social Infrastructure Administrative Offices Banks Food Courts Club House Commercial Area Common Security & surveillance Business Centre Training Centre Convention & Exposition Halls Exclusive township

Support Infrastructure

Central Instrumentation center Wet laboratories Central fire protection services Emergency medical center Logistics hub & truck terminals Parking Bay Central warehouses Customs bonded warehouses &

ICD Bulk solvents storage Central workshops Petrol & diesel outlets

Land Sales

Details No. of Units Total Area Allotted in acres

Land allotted as on date 104 1189

Non-SEZ Area & SEZ area

Land allotted in percentage 86

Success Story of JNPC1. Concession Agreement made during the year 2004

2. Operations started during the year 2008-09

3. As on today land allotted to about 86% of the park capacity

4. Employment provided to the tune of 11000 people and indirect employment is several times

5. Investment brought to pharmacity is about Rs 7000 Cr

6. Occupants are from Innovators, Generic companies, Indian giants, multinational companies & first generation entrepreneurs

7. Continual improvement in upgrading technologies and facilities to meet the customer requirements

8. This project is undertaken under PPP model with private participation and this is one of the successful pharma park in India

Proposal for cluster at RPCIL

ROLE OF Cost Accountant in Pharma Industry

1. Pharma Industry is competing with China and other developing /developed nations

2. In fact 60% of Raw Materials are imported from China, even the technologically India is superior

3. Costing of the Process and Product will play a major role in competing with China and other countries

4. The Critical Parameters for Cost Accountants in Pharma industry is distribution of Utility Cost for the product and man power allocation cost

5. Cost Accountant plays a crucial role in marketing the product

ROLE OF COST AND MANAGEMENT ACCOUNTANT IN THE GROUWTH OF PHARMA SECTOR

There are numerous factors responsible for its growth like R&D,

Govt; policy, patent act etc; besides these factors there is one

important input which enables Indian pharma sector to compete

with other players. i.e cost effectiveness.

CMA works hard in supplying the required cost date for enabling

the decision makers in taking strategic decisions like launching

of new generic drugs, making alliances with other firms, capital

investment in technology, infrastructure building

Conclusion

1. Residual Andhra Pradesh will attract more investment because of business opportunities and availability of technical manpower in this reasons

2. If MAT & DDT is removed more MNCs will invest in our Region in SEZ

3. More investments are possible after the tax benefits to Residual Andhra Pradesh

4. Political Support and support by bureaucrats will boost the investment in this region

Thank You