dec-2019-jan-2020-news-letter.pdf - Bulk Drug Manufacturers ...

December 2019-January 2020

NEWS LETTER

BI-MONTHLY NEWS LETTER OF BULK DRUG MANUFACTURERS

ASSCIATION INDIA C-25, Industrial Estate, Sanathnagar, Hyderabad-500018

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Govt. mulls tax break for desi pharma companies

This is one of the key recommendations made by the department of pharmaceuticals (DoP) as part of its budget proposal to the finance ministry, an official source said. The pharmaceutical industry is hopeful that the government will restore the weighted deduction on expenditure incurred on R&D to 200%.

In a move to boost research in drug manufacturing, the government is considering to restore tax benefits on research and development (R&D) expenditure incurred by local pharmaceutical companies in the upcoming Budget 2020. This is one of the key recommendations made by the department of pharmaceuticals (DoP) as part of its budget proposal to the finance ministry, an official source said. The pharmaceutical industry is hopeful that the government will restore the weighted deduction on expenditure incurred on R&D to 200%. At present, the industry enjoys 150% weighted deduction on R&D but it is scheduled to come down to 100% from 2020 unless the government takes a call on it. The government had introduced a weighted tax deduction of 200% on expenditure on R&D in the 2010 budget, in order to boost innovation in the country. However, the government slashed the benefit to 150% from 2017 onwards and 100% from 2020.

US scientific body launches largest collection of formulations data in India

The Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. It can be a potential game changer for India's pharmaceutical and agrochemical sector, the CAS said in a statement. A division of the American Chemical Society (CAS), specialising in scientific information solutions, has launched Formulus , the world's largest collection of formulations sourced from journals, patents and product inserts in India. The Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. It can be a potential game changer for India's pharmaceutical and agrochemical sector, the CAS said in a statement. The Formulas streamlines and simplifies the time-consuming process of formulating new products and can help new innovations get to market faster, it said. The CAS plans to hold workshops in Mumbai, Hyderabad and Bangalore to demonstrate its capabilities for formulators and researchers. "The new CAS collection of formulations has been curated from information found by hundreds of scientists from numerous sources," said Molly Strausbaugh, CAS Assistant Director. This data clearly identifies formulation ingredients and their roles and provides users with critical insights, decreasing development time, he added. "By speeding up this process, formulators are able to receive reliable information more quickly, allowing them more time to spend on the real-world challenges they're trying to solve," Strausbaugh said.

Will provide health cards to 1.10 cr state residents under Atal Ayushman Yojana: U’khand CM

Another point of concern in the scheme is the use of fraudulent measures deployed by many hospitals in Uttarakhand. As many as 14 hospitals were de-empanelled by the health department because they had tried to extort money from the scheme through fraudulent means. Atal Ayushman Yojana, launched on the birth anniversary of former Prime Minister Atal Bihari Vajpayee last year, completed its first year in Uttarakhand on Wednesday. Speaking at an event held at the CM's residence in Dehradun to mark the occasion, chief minister Trivendra Singh Rawat hailed Atal Ayushman Yojana as ‘the world's largest health plan’, claiming that 10 crore BPL families (across the country) have benefited from this scheme. He added that the state has now set an ambitious target of providing golden cards (which entitle people to receive treatment worth Rs 5 lakh) to 1.10 crore state residents under the scheme. He also felicitated the representatives of government and private hospitals who had done commendable work under the scheme. Speaking on the occasion, DK Kotia, chairman of Atal Ayushman Uttarakhand Yojana, said that Uttarakhand is second only to Kerala in providing golden cards and so far, 34.7 lakh cards have been made under the scheme. The official also claimed that one lakh patients had availed treatment under the scheme in the past year. While the government hailed the scheme as a ‘mega success in the state’, many patients

whom TOI spoke to, said that a lot more needed to be done to improve the services available under the scheme. Mamta Kumari, a Premnagar resident, said, “I was referred to a private facility after doctors said that I needed to undergo a Caesarean delivery. However, I had a normal delivery. Later, we were made to pay the hospital charges for normal delivery as the authorities there told us that Atal Ayushman Scheme is not applicable when a woman has a normal delivery.” Another patient, Chandramohan Sodhi, 58, a Race Course resident, said that only the hospitals offering multiple specialties should be empaneled under the scheme. “During emergency, a heart patient is rushed to the nearest empaneled hospital. But quite often, when the patient reaches there, the hospital authorities say that they don’t offer heart treatment package. Likewise, so many hospitals have just picked up few treatment packages based on their own convenience and not on the convenience of patients.” Another point of concern in the scheme is the use of fraudulent measures deployed by many hospitals in Uttarakhand. As many as 14 hospitals were de-empanelled by the health department because they had tried to extort money from the scheme through fraudulent means.

Department of Pharmaceutical asks industry to regulate promotional practices

The DoP secretary held a meeting on 23 December to review the implementation of the uniform code of pharmaceutical marketing practices (UCPMP) which is being voluntarily adopted by the pharmaceutical companies since 2015. - With concerns over the influence of offering gifts to medical professionals by pharmaceutical companies surging, the Department of Pharmaceutical (DoP) has asked the pharmaceutical industry to step up efforts at self-regulation or it will be compelled to bring in a law to regulate promotional practices in the pharmaceuticals industry. The DoP secretary held a meeting on 23 December to review the implementation of the uniform code of pharmaceutical marketing practices (UCPMP) which is being voluntarily adopted by the pharmaceutical companies since 2015. Following recent complaints of unethical marketing practices by pharmaceutical companies, a committee is likely to be set up by the DoP which will keep a strict vigil on any such violations, shared one of the persons attending the meeting. The DoP secretary has told both the domestic and multinational pharma lobby groups along with the medical device industry to “strictly” comply with the code of ethics, added the same people. The pharma lobby groups and the medical devices lobby group have been asked to share their comments on the issue within a week. “A committee is also likely to be set up by the DoP pharma to check on any such violations by the pharma companies in future,” added another person. Chaired by the DoP pharma, the meeting was also attended by the National Pharmaceutical Pricing Auhtority (NPPA) chairperson Shubhra Singh and senior officials in the DoP. The meeting was necessitated following a recent study by non-governmental organisation (NGO) Sathi (Support for Advocacy and Training to Health Initiatives), which claimed that “promotional practices of the pharmaceutical industry and implementation of status of related regulatory codes in India lacked credibility”. It revealed that medical representatives disclosed widespread use of bribes, including foreign trips, microwave ovens, expensive . smartphones, jewellery and even women, by pharmaceutical companies. The report also revealed that medical representatives (MRs) talked of the tremendous pressure exerted by companies on them through high sales targets. The report is based on in depth interviews with 50 MRs, areas sales managers, allopathic and Ayush doctors and pharma executives from six cities conducted last year. Simultaneously, earlier this month another non government organisation also blamed well-known Swiss drug maker for providing inducements in the form of honorariums for

participation in conferences, travel assistance, accomodaion, food expenses, all of which are strictly prohibited under the UCPMP as well as the Indian Medical Council (Professional conduct, Etiquette and Ethics), Regulations 2002. A complaint in this regard was sent to the DoP. The DoP has been dragging its feet on the draft legislation aimed at increasing transparency in financial relationships between healthcare providers and pharmaceutical manufacturers as well as deterring unethical practices since 2016. According to the UCPMP, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc. Gifts for the personal benefit of healthcare professionals and family members, both immediate and extended, such as tickets to entertainment events, are also not to be offered or provided. However, there has been no headway on the proposed legislation. The government had in 2011 come out with the voluntary marketing code and its amended version in 2015 following complaints of unethical marketing practices, like bribing doctors and pharmacists through foreign junkets, gifts and other incentives. However, voluntary code has failed to deter unethical practices. “The Pharma secretary also warned that if there are more violations that come to the light in future, the department will be compelled to make it UCPMP mandatory, which has penal provisions for the violators,” added the second person, quoted above.

Year end review 2019: Health Ministry highlights PMJAY amongst various schemes

The Ministry of Health and Family Welfare (MoHFW) recently unveiled the report card for the year and the achievements in the various segments of the healthcare sector. The highlight of this year’s health report card by the MoHFW was Ayushman Bharat - Pradhan Mantri Jan Aarogya Yojana (AB-PMJAY) which aims to holistically address health (covering prevention, promotion and ambulatory care), at primary, secondary and tertiary level by adopting a continuum of care approach. “So far 33 states and UTs are implementing the scheme. Treatment worth Rs.9999.76 cr for 69,19,973 hospital admissions has been provided under the scheme. 68,106 cases of hospitalizations were availed outside the state of residence. Also 19,839 hospitals have been empanelled under the scheme and 11.51 crore scheme cards, which include state cards have been issued to the beneficiaries. As far as the Ayushman Bharat-Health & Wellness Centres (HWC) are concerned the approvals for more than 60,000 have been accorded to the states/UTs (except Delhi) and as reported by the states/UTs on the AB-HWC Portal, 26743 HWC have been operationalised which includes 11,111 Sub Health Centres (SHC) -HWCs, 12,800 Primary Health Centres (PHC)- HWCs and 2,832 Urban Primary Health Centres (UPHC) – HWCs. Other programmes of the MoHFW, which fared well are:- Mainstreaming of AYUSH: Mainstreaming of AYUSH has been taken up by allocating AYUSH services in 7,620 PHCs, 2,758 CHCs, 495 DHs, 3,923 health facilities above sub- centre but below block level and 364 health facilities other than CHC at or above block level but below the district level. Prime Minister’s National Dialysis Programme: PMNDP has been implemented in total in 472 districts of 34 States/UTs through 825 Dialysis Centres deploying 4920 machines. Total of 5.80 lakh patients availed dialysis services and 58.14 lakh Hemo-dialysis sessions held as on 30th Nov 2019. Pradhan Mantri Surakshit Matritva Abhiyan (PMSMA): In the FY 2019-20 (up to 15th

December 2019), 37.84 lakh ANC check-ups conducted under PMSMA, whereas more than 2.76 lakh high-risk pregnancy identified and 600 volunteers registered under PMSMA. Pradhan Mantri Swasthya Suraksha Yojana (PMSSY): 1st session of undergraduate MBBS course (2019-20) with 50 seats started at six new AIIMS viz. Raebareli, Kalyani, Gorakhpur, Bhatinda, Deogarh and Bibinagar. OPD services at AIIMS Nagpur commenced on 07.09.2019. Achievements for this year include: Drugs and diagnostic kits for Hepatitis C are procured centrally to achieve economies of scale and supply to all states is under process. A pool of approx. 435 master trainers created through national-level Training of Trainers (TOT) for diagnosis and care, support and treatment of viral hepatitis and monitoring and evaluation. Treatment centres for the management of hepatitis C established in 22 states across 95 districts and 24 Model Treatment Centres (MTC) have become functional in 22 states (till Sept 2019). A web portal launched on 28th July 2019 at Mumbai for paperless data recording and reporting.

New technology allows gene therapy dose regulation

The achievement, published in the scientific journal 'Nature Biotechnology', gives gene therapy pioneers the first practical way to adjust therapeutic gene expression. Washington D.C: Scientists have engineered a special molecular mechanism that can be integrated into gene therapies to allow clinicians to control dosing. The achievement, published in the scientific journal 'Nature Biotechnology', gives gene therapy pioneers the first practical way to adjust therapeutic gene expression. The failure to achieve such a basic safety function has contributed to the development of gene therapy that otherwise seeks to tackle genes. The approach of scientists tends to overcome a significant security challenge and can lead to greater use of the method. Michael Farzan, who is a principal investigator from the Scripps Research team, demonstrated the power of their new switching technique by incorporating it into a gene therapy that produces the hormone erythropoietin, used as a treatment for anaemia. They showed that with a special embedded molecule, they were able to suppress the expression of their gene in very low concentrations and thus to improve gene expression across a wide dynamic range by using injected control molecules such as morpholinos. For other uses, the Food and Drug Administration has proven effective. Michael said: "I think that our approach offers the only practical way at present to regulate the dose of a gene therapy in an animal or a human." Gene therapies work by inserting copies of a therapeutic gene into the cells of a patient.For instance, the patient was born without functional copies of the needed gene. The strategy has long been seen as having enormous potential to cure diseases caused by defective genes. It also could enable the steady, long-term delivery to patients of therapeutic molecules that are impractical to deliver in pills or injections because they don't survive for long in the body. However, gene therapies have been viewed as inherently risky because once they are

delivered to a patient's cells, they cannot be switched off or modulated. As a result, only a handful of gene therapies have been FDA-approved to date. The investigator further mentioned that the simplicity of the technology and the approval of morpholines by FDA may allow the new transgenic switching device to be used in a wide range of gene therapies. A transgenic transformation from the family of ribonucleic acid (RNE) molecules, known as hammerhead ribozymes, has been developed by the Farzan team, including the studying co-authors Guocai Zhong, PhD and Haimin Wang, respectively post-doctoral and Farzan lab research assistance. A therapeutic transgene containing the DNA of such a ribozyme will thus be copied out in cells into strands of RNA, called transcripts, that will tend to separate into two pieces before they can be translated into proteins. However, this self-cleaving action of the ribozyme can be blocked by RNA-like morpholinos that latch onto the ribozyme's active site; if this happens, the transgene transcript will remain intact and will be more likely to be translated into the therapeutic protein. The ribozyme thus effectively acts as an "off switch" for the transgene, whereas the matching morpholinos, injected into the tissue where the transgene resides, can effectively turn the transgene back "on" again--to a degree that depends on the morpholino dose. The scientists started with a hammerhead ribozyme called N107 that had been used as an RNA switch in prior studies, but they found that the difference in the production of a transgene-encoded test protein between the "off" and "on" state was too modest for this ribozyme to be useful in gene therapies. However, over months of experimentation, they were able to modify the ribozyme until it had a dynamic range that was dozens of times wider. The team then demonstrated the ribozyme-based switch in a mouse model of an EPO gene therapy, which isn't yet FDA-approved but is considered potentially better than current methods for treating anaemia associated with severe kidney disease. They injected an EPO transgene into muscle tissue in live mice and showed that the embedded ribozyme suppressed EPO production to a very low level. Injection of a small dose of the morpholino molecules into affected tissue strongly reversed that suppression, allowing EPO production to rise by a factor of more than 200--and stay there for more than a week, compared to a half-life of a few hours for EPO delivered by a standard injection. Those properties make the ribozyme-based switch potentially suitable for real clinical applications. Farzan and his colleagues are now working on adapting their ribozyme exchange strategy to be used as a fail-safe gene therapy tool, which permanently disables errant transgenes.

Soon, interest subsidy on loans for pharmaceutical infrastructure, technology upgrades

The Department of Pharmaceuticals proposes to bear 6% of the interest on loans up to Rs 8-10 crore for three years, through a public sector financial institution to be selected after open competitive bidding. The government is set to roll out an interest subsidy scheme to help small pharmaceutical companies upgrade infrastructure and technology to globally accepted standards, subject to achieving export targets. The Department of Pharmaceuticals proposes to bear 6% of the interest on loans up to Rs 8-10 crore for three years, through a public sector financial institution to be selected after open competitive bidding.

“The Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) will help small and medium enterprises and is intended to improve manufacturing practices. We have held extensive consultations with the industry and now are set to launch the scheme in February,” said PD Vaghela, DoP secretary. The DoP has budgeted about Rs 300 crore for disbursal as interest subsidy for 2020-2022. The proposal will be taken up for final approval by the steering committee, a panel of experts under the department, on January 14. The committee will also set penalties for defaulters. Drug companies that avail of the scheme will have to achieve incremental export revenue exceeding the loan amount within 36 months, failing which they will pay a penalty, and the amount borrowed will be converted into a regular loan. “The subvention amount credited to the loan account with the sanctioning commercial bank/financial institution will stand withdrawn if the company defaults,” according to a government official requesting anonymity. The objective is to help small and medium pharma enterprises upgrade from Schedule M, the good manufacturing practices (GMP) laid out in India’s Drugs and Cosmetics Act, to standards mandated by the World Health Organization, which will enable them to compete in the global markets and improve earnings. The lender must ensure that the beneficiary company obtains WHO-GMP certification within two years from the date of first disbursement of the loan. The scheme will also allow procurement of new machinery. “Interest subvention against sanctioned loan by any scheduled commercial bank/financial institution, both in public and private sector, will be provided to medium enterprises of proven track record,” added another official. “The scheme will boost Make in India as WHO-GMP is compulsory for participating in many tenders for supplying in government institutions. The scheme will also help companies to increase exports with strict safety regulations,” the official said. Pharma groups welcomed the scheme, although some said the “export conditions” should be relaxed. “The condition of export activity needs to be delinked from availing the loan. Export registration takes 3-4 years. Hence the DoP should not fix time limits,” a person affiliated with a pharma lobby group said on condition of anonymity.

Vizag to host 2021 global healthcare summit, over 500 delegates to attend

For the first time, the 14th Global Health Care summit will be held in AP and is expected to boost the healthcare in the region. Visakhapatnam: Visakhapatnam has been selected as the venue for Global Health Care Summit (GHS) to be held in January, 2021. Preparations and planning have commenced a year ahead for the mega three-day summit, being organised by the American Association of Physicians of Indian Origin (AAPI). Visakhapatnam MP MVV Satyanarayana brochure of the summit here on Monday. For the first time, the 14th Global Health Care summit will be held in AP and is expected to boost the healthcare in the region. Around 500 delegates from across the globe will be attending the summit, which will focus on various communicable and non-communicable diseases, public health hazards, emergency medical care, eradication of tuberculosis, preventing maternal mortality, control of Hepatitis B and and include anti-obesity awareness walk, women’s forum, adoption of villages. AAPI president Dr Sudhakar Jonnalagadda addressed the media on Monday about the

upcoming event. “The summit will focus on the present health situation in India and international advancement in healthcare. Delegates from across the world would gather in Visakhapatnam and exchange their views and the discussions would be published in a journal, which will be distributed across various institutions in the world for effective implementation of various strategies in healthcare delivery.” Dr Prasad Chalsani, chair USA of AAPI, pointed out that as Visakhapatnam has been selected as the venue to host the event, it will also boost the healthcare in the region and draw the attention of the government to AP to improve the health sector. Dr Raj Bhayani, from AAPI said, “Making India TB-free by 2025 is our aim. We are also working in areas of alternate medicines along with the Ministry of Ayush.” Dr K Satyavaraprasad, head of the department of neurosurgery at KGH, said, AAPI and Amcana have been focusing on traumatic brain injury (TBI). They have developed the first set of guidelines for managing TBI with help of leading trauma care specialists. These are now being reviewed by MOH GOI and parts of the guidelines are being included in the overall trauma management. As a part of this initiative, AAPI will collaborate with various state governments to organise CPR and BLS training for approximately 500 police workers.”

A look at how the healthcare industry fared in 2019 While Ayushman Bharat dominated the discourse, this year also witnessed a significant increase in the violence against doctors. One of the most notoriously memorable television images of 2019 involved a prominent TV anchor thrusting her mic on the face of an on-duty doctor and demanding answers about the poor state of healthcare in Bihar! The Muzaffarpur Encephalitis tragedy claimed over 100 children, but the behaviour of the news anchor was symptomatic of the country at large where doctors often find themselves at the receiving end of public anger. Violence against doctors was a major burning issue in 2019. In many parts of the country, doctors joined a strike against rising instances of violence, reigniting the debate over safety laws and safe working environment for them. In the year gone by, India also celebrated one year of the completion of the ambitious Ayushman Bharat scheme aimed at providing health cover to as many as 50 crore people. Prime Minister Narendra Modi also announced a ‘Fit India’ campaign to spur Indians towards fitness and health. Let’s take a look at the Healthcare industry in 2019 and the way forward: One Year of Ayushman Bharat: Achievements and loopholes As Prime Minister Narendra Modi’s flagship programme Ayushman Bharat or Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) completed a year, there exists a continuing friction between the government and private hospitals over treatment packages and rates has been hampering the promising scheme which helped as many as 46.4 lakh people receive treatment through hospitalization in its first year. The government announced revisions to many packages, increasing rates of 270 of them. However, the Indian Medical Association (IMA) expressed dissatisfaction at the revised rates, saying participation in the scheme was still not viable for private hospitals. Ayushman Bharat is a potentially game-changing scheme for Indian healthcare but the government and private hospitals have to reach a common ground if it is to become successful. We expect the government to arrive at a genuine understanding with private hospitals over the treatment packages so that private participation under the scheme is increased. The government must also boost efforts in the coming year to improve awareness about the scheme on the ground while also ensuring that frauds under the scheme are kept under check. Niti Ayog adviser Alok Kumar said that India’s healthcare system desperately needs more private participation in smaller towns to run the Ayushman Bharat programme efficiently. This is why the need to incentivize the private sector to open more hospitals in tier II and tier III cities cannot be underlined enough. This can be done by offering tax

breaks and helping the private sector in procuring land. Empanelment of small hospitals and nursing homes in PMJAY must also be accorded due priority because the majority of Indians still seek treatment at such centres, particularly in smaller towns. Violence against Doctors in 2019 As mentioned in the opening, rising instances of violence against doctors hogged major limelight in 2019, resulting in a nationwide strike by healthcare practitioners. While the issue of violence on doctors is not new, the incidents of the year helped create a situation of urgency and highlight the need for action. A bill was drafted by the health ministry to check violence against doctors and healthcare professionals. However, the Home Ministry shoved it under the carpet, stating that there was no need for a separate law. In the past decade, there have been several attempts to legislate a law on this issue but they have not succeeded. Some of the solutions for this include adequate checking of visitors upon entry and their mandatory registration, strong action against people who assault doctors, putting an evacuation plan in case of major violence as well as setting up grief counselling stations that help bereaved families to cope up with the loss. Fit India Movement Non-communicable diseases such as cardiovascular diseases, cancers, chronic respiratory diseases, diabetes, hypertension etc are estimated to account for 60 per cent of all deaths in our country today. With a lack of physical activity emerged as a major concern in India, the Prime Minister’s initiative to launch the nation-wide ‘Fit India’ movement was a welcome step. The initiative is aimed at motivating people to make fitness a part of their daily lives through sports and physical activities. A special committee was also formed to further the agenda of the campaign. However, it needs to be much more than a slogan. Schools, colleges and universities must actively get involved in the campaign to make a sport or physical activity mandatory for all students. Similarly, workplaces must also be spurred to induce employees to indulge in physical activity, sport, gym or yoga on the office floor every day. Medical Devices regulation Another noticeable development of the year was the government’s initiative to strengthen and streamline the regulation of medical devices. The Union Health Ministry released fresh draft notifications to regulate all medical devices in India under the Medical Device Rules, 2017. The new regulations promise to streamline the highly unregulated medical devices sector in the country. The move is also expected to significantly increase the level of compliance required by manufacturers or importers of medical devices. This will help in boosting quality control and will also serve as a motivation for Indians manufacturers to improve their quality controls to international standards. Healthcare Sector Expectations from the year 2020 Ayushman Bharat and the role of private hospitals in making it a success, continued to remain a point of contention this year. The continuing friction between the government and private hospitals over treatment packages and rates has been hampering the promising scheme. Ayushman Bharat is a potentially game-changing scheme for Indian healthcare but the government and private hospitals have to reach a common ground if it is to turn successful. Apart from ironing out differences with the private sector, the government must also boost efforts in the coming year to improve awareness about the scheme on the ground while also ensuring that frauds under the scheme are kept under check. Another noticeable development of the year was the government’s initiative to strengthen and streamline the regulation of medical devices. The Union Health Ministry released fresh draft notifications to regulate all medical devices in India under the Medical Device Rules, 2017. The new regulations promise to streamline the highly unregulated medical devices sector in the country. The move is also expected to significantly increase the level of compliance required by manufacturers or importers of medical devices. In the coming year, we are expected to see more healthcare companies turn to expansion in tier-II cities as competition and market saturation impedes growth prospects in top tier cities. In 2020 and over the next few years, tier-II cities such as Patna, Lucknow, Dehradun, Bhubaneshwar, Jaipur, Jodhpur etc are set to emerge as

hotspots of healthcare business expansion. The year-end analysis will be incomplete without talking about the impact of the economic slowdown. With the slowdown impacting incomes particularly in rural areas, the government must take measures to boost its healthcare spending to be able to assure basic healthcare to the deprived sections of the population. The author is the MD at Paras Healthcare.

Hyderabad: 150 industries to get land in phase 1 of Pharma City

The government is speeding up the Pharma City project as all the required permissions, including environmental clearance, have already been granted by the Centre. Though the project was conceived in 2015, it took four years to get the clearances. With the Centre granting the National Investment Manufacturing Zone (NIMZ) status to Hyderabad Pharma City, the Telangana government is now going ahead with its plans to allot land to as many as 150 firms in phase I. The Telangana State Industrial Infrastructure Corporation (TSIIC) has already acquired about 8,500 acres for the Pharma City project, which is coming up at Mucherla in Rangareddy district on the outskirts of Hyderabad. Senior officials said 350 firms had approached the government seeking land in Pharma City. “Initially, land will be allotted to 150 pharma units. Several pharma associations are queuing up for allotment of land. We will launch the application process soon and allotment will be made directly to individual companies,” principal secretary, industries, Jayesh Ranjan told TOI on Thursday. A couple of days ago, industries minister KT Rama Rao had revealed that Pharma City would be operationalised this year. Top sources in the government said once infrastructure facilities are in place, the process of land allotment would be completed before May this year. The government is speeding up the Pharma City project as all the required permissions, including environmental clearance, have already been granted by the Centre. Though the project was conceived in 2015, it took four years to get the clearances. Ten days ago, Union industry minister Piyush Goyal set the ball rolling by asserting that the Centre had granted its final approval for the project by giving it NIMZ status. In fact, the Centre approved NIMZ status to Pharma City in January 2016 but kept it on hold. Earlier, the Telangana industries department submitted a techno-economic feasibility study and development plan report for getting the final approval. Based on the reports, the final approval was granted in the second week of December. The government had taken Rs 750 crore loan from Hudco, while KTR had written letters to the Centre seeking Rs 3,418 crore for creation of a full-fledged Pharma City in the form of a grant, besides allotment of natural gas on a preferential tariff basis for use as fuel by pharma units. “The Telangana government asked for a grant-in-aid of Rs 1,318 crore for creation of infrastructure, besides Rs 2,100 crore, which will be half the expenditure to be incurred for creation of internal infrastructure and common effluent treatment plants,” a senior official said.

The potential of the Indian pharmaceutical industry

According to research from the Indian Pharmaceutical Alliance, the country’s pharma

sector has capacity to grow. This article investigates some of the goals, challenges and

proposals the report sets out for the industry.

A document from the Indian Pharmaceutical Alliance (IPA) has outlined the steps that

need to be taken by the pharma industry in the country to continue as one of the largest

global markets. In a report titled ‘The Indian pharmaceutical industry – the way forward’, the

association explains Vision 2030; a plan which defines their growth aspirations.

This article delves into aspects of the plan, discussing the challenges and opportunities

it presents.

Aims for India

The goals established by the IPA are intended to define the advancement of the Indian pharmaceutical industry and help it to realise its potential.

The report outlines four key drivers of growth:

Increasing economic growth in India

New innovative products

Strong growth in the US market

Increased foothold in markets such as Japan and China.

According to the report, 2.7 million jobs have been created both directly and indirectly as a result of the growth of pharmaceutical industry in India and the current CAGR is estimated to be between seven and eight percent. This would result in the sector being worth up to $90 billion by 2030, but the association suggests that the industry has the potential to rise at a CAGR of up to 11 or 12 percent, potentially reaching $120 to $130 billion by 2030.

The alliance presents four primary goals as the outcome for their plan:

High-quality and affordable medicines: as part of a scheme to implement universal healthcare in the country, low prices for drugs are needed to reduce the costs for patients.

A world leader: the report sets a goal of three to five molecular entities launched or in late clinical trial phases and 10-12 innovation launches per year by 2030.

A global drug supplier: by establishing a market in the US generics space and developing trade with other countries, India could become the world’s largest supplier of drugs by volume.

Contributing to the economy: currently valued at $11 billion, the pharmaceutical industry could bring even more income into India.

Therefore, there is still room for the industry to grow, and these outcomes provide a structured plan to work towards.

Challenges for the Indian pharmaceutical industry

The IPA notes that there are still roadblocks for the industry. These include:

A lack of a stable pricing and policy environment

The challenge posed by frequent and

unexpected changes to domestic pricing policy in India have created an uncertain

environment for investments and innovations. The IPA suggests that both the

government and stakeholders work together to develop a plan to produce affordable

drugs for Indian patients.

Lack of capabilities in the innovation space

The report states that the government needs to invest in research initiatives and talent

in order to grow India’s innovation. Clinical trials should also be supported and

subjectivity in certain regulatory decision-making removed.

External markets

The report comments that India is heavily reliant on other countries for intermediates

and active pharmaceutical ingredients (APIs), with approximately 80 percent of the

APIs used in India fulfilled by China. The country is therefore at the mercy of supply

disruptions and unpredictable price fluctuations. Implementing improvements to

infrastructure would help in the development of internal facilities to stabilise supply.

The US generics market

The success of generic exports to the US have started to plateau. One reason for this

is price erosion, according to the report. Due to increased buyer consolidation and

higher competition in key molecules, this market is starting to wane.

Quality compliance scrutiny

India has experienced the highest number of FDA inspections since 2009; therefore,

continued investment into upgrading quality standards will divert capital away from

other areas of development and distract from growth, says the alliance.

Proposals for the pharma industry

The IPA emphasises that “Indian pharmaceutical companies need to take bold strategic

moves into uncharted territories.” In the report, the association suggests some

actionable steps to encourage the growth of the industry.

Improving communication between industry stakeholders and Indian regulators would

help to build a stronger platform for pharma while developing more certainty around

drug costs, such as policies that provide a framework for pricing, would contribute to a

steady regulatory environment.

Establishing a Ministry of Pharmaceuticals was suggested as an effective way to help

the Indian pharmaceutical industry grow. This would be an independent body that

would enable better coordination and faster decision-making.

A further suggestion is for the Indian pharmaceutical industry to focus on API

manufacturing, so that there is less reliance on imports into the country. This could be

completed several ways, including constructing dedicated zones for the manufacture of

APIs.

The report further highlights a step already being undertaken by the Indian government

to encourage industry growth. In provinces such as Andhra Pradesh and Uttar Pradesh,

local governments have announced their intention to build ‘pharma parks’, which will

lend the industry a competitive advantage. However, more measures can be taken on

the path towards growth.

Boost needed for innovation in Indian pharma, study finds

Another proposal is to simplify regulatory approval processes. Investment in emerging

R&D fields is much higher than for generic products, according to the report, so

creating a more efficient regulatory approach could aid in increased innovation.

It was suggested that waiving local clinical trials for drugs approved and marketed in

the EU, UK, Australia, Canada, Japan and the US could streamline guidelines for

clinical trials. Similarly, working with other global regulatory bodies could help

encourage pharmaceutical growth in India. This could be achieved by participating in

ICH and collaborating closely with agencies of countries with large markets.

Conclusion

Improving communication between stakeholders and Indian regulators would help to

build a stronger platform for pharma”

The IPA has set out specific goals to guide and enable the pharmaceutical industry in

India to grow and develop.

Despite the challenges highlighted above, the association counters these with

actionable steps the industry can take to encourage expansion, such as founding a

Ministry of Pharmaceuticals and relying less on API imports.

The report remarks that “concerted efforts by all stakeholders – Indian pharmaceutical

companies, the government and regulatory agencies and IPA – are needed to achieve

the aspiration of eleven to twelve percent CAGR.”

Their role, they say, will be to facilitate greater collaboration between stakeholders and

the government. Combined with all other efforts, the IPA believes that these goals from

their Vision 2030 plan can be achieved.

New API Park in Dhaka an opportunity for Indian cos to build tie-ups with pharma & related industries in Bangladesh

A Raju, Hyderabad Friday, January 31, 2020, 08:00 Hrs [IST] With Bangladesh setting up a new Active Pharmaceutical Ingredients (API) Park near Dhaka, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) is viewing it as the best opportunity for the Indian players to build more business tie-ups with pharma and related industries in Bangladesh. As Pharmexcil is participating in the upcoming Asia Pharma Expo by setting up an India Pavilion at International Convention City at Bashundhara (ICCB) in Dhaka in February, the council feels that this is a good opportunity for the Indian firms to build a solid business networking with the firms in Bangladesh and enhance India’s export. According to Udaya Bhaskar, director general of Pharmexcil, the new API Park in Dhaka, which is being built with about 47 pharmaceutical manufacturing units, offers immense potential for the Indian API manufacturers to have joint ventures, technology tie-ups, and exports of the raw materials and other pharma chemicals to the industries in Bangladesh. “As we all know that APIs play a crucial role in the development of medicines, every country is planning to establish its own base for APIs and so is Bangladesh building its own API base. As India has also brought in its new policy on APIs and planning to set up many more API manufacturing clusters, the firms manufacturing APIs in India can also partner with API manufacturers in Bangladesh and can enter into MoUs, joint ventures and partnership with the Bangladesh firms and can develop a long term business relationship that would help in enhancing India’s exports and both the countries can benefit mutually,” observed the Pharmexcil DG. As the India Pavilion is being organised at Asia Pharma Expo from February 28 to March 1st, 2020, the Pharmexcil DG wants the Indian firms to make maximum use of this opportunity. This exhibition is being organised by GPE expo jointly with the Bangladesh Association of Pharmaceutical industries since year 2003 at Dhaka. This exhibition is offering an unparalleled international trade platform to the entrepreneurs manufacturing and exporting the pharma engineering machineries and pharma bulk active chemicals to explore business with the Bangladesh pharmaceutical industry.

Currently, the local pharma market of Bangladesh is having more than 300 pharmaceutical companies and is exporting to US$ 70 million pharmaceutical products to different countries. As the country has been allowed to extend the manufacture of patented pharma formulation for the next 17 years up to 2033, the Bangladesh pharma sector is planning to increase its exports to US$ 60 billion in the next one to two years by 2021. This means clearly Bangladesh is moving with a rapid pace to catch up the international markets and Indian players can play a vital role in enhancing the country’s growth with mutual benefits to both India and Bangladesh.

Industry recommends prefix or suffix in existing brand name to be allowed on change in API

formulation Worried about the prospects of pharmaceutical business getting impacted, the Indian pharma industry has recommended that a prefix or suffix in an existing brand name to be allowed on change in active pharmaceutical ingredients (API) formulation in the same therapeutic segment towards patient safety. The Indian Drug Manufacturers Association (IDMA) has proposed to the government that brand name of medicines be allowed to be retained if change of API formulation is in same therapeutic segment with suitable prefix or suffix in an existing brand name for patient safety. In a circular sent to all central and state regulators’ offices on May 16, 2019 former Drugs Controller General of India (DCGI) Dr S Eswara Reddy had said that his office has received information that some drug manufacturing companies, after changing the APIs of a formulation are still continuing with marketing the products in the old registered brand names. The drug regulator stated that the practice of changing the key therapeutic ingredients in a drug formulation without changing the brand name “is not only misleading but may also result in undesirable pharmacological effects as the consumer would take the formulation assuming that it has the earlier composition.” In a circular, it has asked its officials to take “all measures” to prevent companies from retaining the same brand name for different formulations. The apex drug regulator’s move aims at preventing patients from accidentally taking the wrong medicine in cases where pharmaceutical companies change the composition of their drug brands, but continue to sell the new formulation under the old brand name. The notification comes nearly eight years after the issue was deliberated by the Drugs Consultative Committee (DCC) in three separate meetings held between 2008 and 2011. “Drug Consultative Committee (DCC) has also recommended that such type of practice needs to be discouraged and State Drugs Controllers (DCs) should ensure that the same brand name should not be permitted to retain by the manufacturers if the composition of the API(s) in the new formulation is changed,” stated the circular. “In view of the above, State DCs are requested to take all measures to discourage the practice of marketing of drug formulations with changed composition without changing the brand names and ensure that the same brand name is not permitted to be retained by the manufacturer, if the composition of the API(s) in the new formulation is changed,” it added.

DCGI had reminded the drug controllers that this issue was discussed repeatedly in three Drugs Consultative Committee (DCC) meetings held on December 10, 2008, October 20, 2010 and February 15, 2011. In all the three meetings, the experts found that this practice of the manufacturers was a serious issue and need to be stopped with legal measures. However some state licensing authorities have maintained that they are authorised to give approval for generics and not for brand names under the Drugs and Cosmetics (D&C) Act, 1940. Brand names for drugs fall under a separate category 5. Retaining the same brand name or changing the brand name in case composition of drug is changed is the subject matter of trademark.

REGD. NO. D. L.-32004/99

&.A.-&.W.-3f.-27012020-215690 CG-DL-E-270I202O-2I5690

EXTRAORDINARY

PART Section Sub-section (i)

PUBLISHED BY AUTHORITY

w. 41]

No. 41}

, , Z3,Z020/FnvS,194l

WDEL TIIURSDAY,JANUARYZ3,2020/MAGRAA\1941

,23 ,2020

432 GU2020 (1)

2 THE GAZETTE OF in : Exrmonomw [PART II—SEC. 3(i)]

" 73

6.0 -8.5

30

250

2100

10

1000

0.2

35

30

AOOO

200

0.10

0.01

0.10

0.01

0.01

0.03

0.10

0.80

0.20

0.80

8.40

0.40

0.10

0.20

0.20

0.02

0.10

0.04

0.20

0.10

0.02

0.09

0.03

3.20

xli. 0.20

xlii. 0.04

Xllii. 0.05

g\by. 0.80

XIV. 0.40

XIVI. 0.02

0.04

XlVill. 0.80

1.92

0.02

0.05

0.20

0.80

liv. 0.01

0.01

0.80

0.10

0.10

0.80

0.20

0.05

0.02

lXlll. 0.08

lXñ7. 0.05

0.05

[ 0.004

IXVII. 0.44

IXViii. 0.10

lXlX. 0.72

IXX. 2.68

[ 0.80

0.40

0.02

Ixziv. 0.05

0.40

lxxvi. 0.05

0.10

6.40

0.20

6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]

0.01

0.20

0.20

0.40

0.20

3.20

0.02

0.20

0.80

0.02

0.40

0.40

0.02

12.80

0.20

6.40

288.00

20.00

0.24

0.02

0.40

0.40

0.40

3.20

0.40

0.40

0.20

0.01

0 33

. . .-15017/12/2018-

MINISTRY OF ENYIRONMENT, FOREST AND CLIMATE CBANGE

NOTIFICATION

New Delhi, the 23rd January, 2020

G.S.R, 44(E).— The following draft of the notification, which the Central Government proposes to issue in

exercise of the powers conferred by sections 6 and 25 of the Environment (Protection) Act, 1986 (29 of 1986) is hereby published, as required under sub-rule (3) of rule 5 of the Envimnment (Protection) Rules, 1986, for the information of the public likely to be affected thereby; and notice is hereby given that the said draft notification shall be taken into consideration on or after the expiry of a period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Any person intereStTd jjy yg}tjjjg any objections or suggestions on the proposals contained in the draft

notification may forward the same in writing, for consideration of the Central Government within the period specified above to the Secretary, Ministry of Environment, Forest and Climate Change, Indira Paryavaran Bhawan, Jor Bagh Road, New Delhi-110003, or send it to Member Secretary, CPCB and Scientist ‘B’ Ministry at the e-mail address i.e. [email protected] and h.kharkwalQnic.in.

Draft Notification

The Central Government heiehy makes the following rules further to amend the Envimnment (Protection)

Rules, 1986, namely:-

1. Short title and commencement- (1) These rules may be called the Envimnment (Protection) Amendment Rules,

2019.

(2) They shall come into force on the date of their final publication in the Official Gazette.

2. In the Environment (Protection) Rules, 1986, iñ Schedule-1, for serial number 73 and the entries relating thereto,

the following serial numbs and entries shall be substituted, namely:-

SL No.

Industry Parameters Stzadard

2 3 4 Bulk Drug

A. EFFLUENT STANDARDS “73 and

Formulation {Pharaiaceuti

gg)

For final outlet of ETP Limiting value for concentration (in mg/1 except for pH

and Bio assay)

i) Compulsory Pamuieters

pH 60-85

3.20

0.80. ".

8 THE GAZETTE OF INDIA : EXTRAORDINARY {PART H—DC. 3(i))

BOD (3 days 27°C) 30

COD 250

TSS 100

TDS 2100

Oil & Grease 10

Bio - Assay Test** 90% Survival of Fish after first 96 hours in 100%

effkient

*Additional Parameters

Ammonical Nitrogen 50

Nitrate Nitrogen 10

’*Benzene 0.05

***Toluene 0.05

***Xylene 0.06

***Metliylene Chloride 0.9

Phosphates as P 5

ChlorideS t000

Sulphates as SO 1000

Fluoride

Sulphides as S

Pbenolic Compounds

Total Residual Chlorine

z inc 5

Iron 3

Copper

Tptal Chromium 2

Hexavalent Chromium (Cr”') 0. I

Cyanide 0.1

Arsenic 0.2

Menu 0.01

had. 0.1

*•**Active Pharmaceutical 0.05

iilj for final outlet of Intfustries discharging to CETP

For each Common Effluent Treatment Plant(CETP), the state Board will prescribe inlet

quality Standards for general parameters, Ammonical Nitrogen and Heavy Metals as per

the design of the Common E&uent Treatment PlanttCETP) and local needs and conditions.

As per notification S.O. 4 (E) dated l'January, 2016

Note:

ZLD = Zero Liquid DiSGhaygp gystem in Bulk Drug and formulation industry is

considered Whcn tTT8tCd e8luent meeting the limits prescribed for compulsory paraz

eters shall be used in Process or Utilities (boiler/ Cooling tower etc.). The reuse of tmated effluent in gardening/ horticulture shall not be considered as ZLD in Bulk Drug and

formulation industries.

** The Bio assey test shall bg conducted as per IS : 6582-1971

Parameters listed as *Additional Parameters" shall he prescribed depending upon the

process and product.

*• • Liz iH shall be a R!*’Cable to industries those are usiyg Benzene, Tnluene, Xylcne,

Methylene Chloride, Chlorobeuzene.

**•*API limits shall be applicable for imits manufacturing API ntlier than antibiotics.

B. EMISSION STANDARDS from Process Reactor Vents/ Tank farm Vents

Parameter Limltlng value for concentration (mg/Nm*)

Chlorine 15 Hydrochloric acid vapour 35

Ammonia 30

Benzene 5

Toluene 100

Acetnnitrile 1000

Dichl iethane 200

Xylene 100

Acetone 2000

be more than 3 N

solvent

D. Antibiotic Residues in the treated effluent of Bulk Drug and Formulation

Industry and CETP witb membership of Bulk Drug and formy&tion Units

Individual antibiotic residues wilt be equal to or lqss than the values given in the below table.

Parameter Limiting value for concentration (pg/l)

i. Amikacin 6.40 0.10

iii. Aug hotericin B 0.01

iv. Ampicillin 0.10

v. Anidulafungin 0.01

vi. Avilamycin 3.20

vii. Azithromycin 0.01 0£0

ix. Bacitracin 3.20

x. Bedaquiline 0.03

xii. Capreomycin 0.80

Cefaclor 0.20

KiV. Cefadroxil 0.80

XV. Cefalonium 8.40

zyi. Cefaloridine 1.60

Cefalotliin 0.80

xviii. Cefazolin 0.40

Cefdinir 0.10

Cefcpime 0.20

Cefixime 0.02

xxii. Cefoperazone _ 0J0

Cefotaxime 0.04

Cefoxitin 3£0

xxv. Cefpirome 0.02

Cefpodoxime 0.10

Cefquinome 0.64

Ceftaroline 0.02

Ceftazidime 0.20

Ceftibuten 0.10

Celtiofur 0.02

Ceflobipmle 0.09

Ceftolozane 0.76

xxxiv. CeRriaxone 0.01

xxxv. Cefuroxime 0.20

xxxvi. Cepbalexin 0.03

xxxvii. Chlorampbenicol 3.?0

xxxviii. Ciprofloxacin 0.02

xxxix. Clarithromycin 0.03

xl. Clavulanic Acid 22.40

xli. Clinadoxacin 0.20

xlii. Clindamycin 0.04

xliii. Cloxacillin 0.05

xliv. Colistin 0.80

xlv. Daptomycin 0.40

xlvL Delamanid 0.02

xlvii. Doripenem 0.04

xlviii. Doxycycline 0.80 1.92

0.02

9

10 THE GAZETTE OF INDIA : EXTRAORDINARY

li. Ertapeneni

lii. Etytbromycin

liii Ethambutol

liv. Faropenem

1v. Fidaxomicin

lvt Florfenicol

lvii. Fluconazole

lviii. Flumequine

lix Fosfomycin

lx. Fusidic acid

lxi. Gati;fioxacin

lxij. Gemifloxacin

lxiii. Gentamicin

lxiv. Imipenem

lxv. lsoniazid

lxvi. Jtraconazole

Lincomycin

lxx. Linezolid

lxxiii. Meropenem

lxxiv. Memnidazole lxxv. Minocycline lxxvi. Moxifloxacin

Nalidixic acid

Narasin

Neomycin

Netilmicin

lxxxii. Nitrofurantoin

lxxxiii. NorBoxacin

lXxRiV. Ofloxacin

IV. Oxacillin

Oxytetracycline

Peooxacin

Phenoxymethylp

enicillin

Piperacillin

XC. Pole

xci. Retapamulin

xcii. Rifampicin

Roxithromycin

Secnidazole

Sparfloxacin

Spcctinomycin

Streptomycin

Sulbactam

Sulfâdiazine Sulfadimethoxin

e

cti. Sutfadoxi0e

ciii. Sulfazoet1toxBzo\

civ. Tazobactam

cv. Tedizolid

cvi. Teicoplanin

cvii. Telitbroinycin )

[PMT II—SEC. 3(i)]

0.05

0.20

0.80 t

0.0I

0.01 t

0.80 !

0.10

0.10

0.80

0.20

0.05

0.02

0.08

0.05

D.05

0.004

0.44

0. 10

0.72

2.68

0.80

0.40

0.02

0.05

0.40

0.05

0. 10

6.40

0.20

0.01

0.20

25.60

0.20

0.20

0.40

0.2O

3.20

0.02

0.20

0.80

0.02

0.02

0.40

0.40

12.80

0.TO

6.40

6.40

288.00

20.00

0.24

0.Z4

1760

3.9Z

0.20

001

cviii. Tetracycline 0.40 Thiamphenicol 0.40

Tiamulin 0.40

Ticarcillin 3.20

Pipeline 0A0

Tildipirosin 0.17

GXiV. Tilmicosin 0.40

Tobraztiycin 0.40

Trimethoprim 0.20

Trovadoxacin 0.01

Tylosin 0.33

Vancomycin 3.20

Viomycin o.80

cxxi. Virginiamycin 0.80.”.

Note:- The dulge containing antibiotic residues shall be incinerated and the staixlard of incinerator notified for

common hazardous waste incinerator or industry specific incinerator shall be applicable.

T.No. Q-15017/12/2018-CPW]

JIGMET TAKPA, Jt. Secy.

Note: The principal rules were publisbed in the Gazette of India, Extraordinary, Part II, Section 3,Sub -section (i) vide

number S.O. 844 J), datad the l9th November, 1986 and last amended vide notification number G.S.R.

952(E), dated the 26th December, 2019.

Uploaded by Dte, of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. Not