‘There is a need to develop a comprehensive vision for the pharma industry in sync with the healthcare delivery system’

India’s pharmaceutical industry, which is estimated to be approximately $26 billion, has made us all proud. We are the world leader in generic pharma production, supplying 20 per cent by value of the global market. Further, India accounts for eight per cent of global production and is exporting to over 200 countries. According to DIPP, Indian drugs and pharmaceutical industry has attracted $11.30 billion worth FDI in the period 2000-2013.

Access and availability of affordable quality medicines is the backbone of universal health coverage. As we all know, in the 12th Plan the government has moved towards implementing UHC and the pharma industry will play a critical role in achieving this ambitious goal. The Indian pharma industry supported by the government has done well by establishing ourselves as the largest maker of finished generics, available at affordable prices. Today, more than 65-70 per cent medicines in the WHO-prequalified list of medicinal products belong to Indian manufacturers in the segments of HIV-AIDs, tuberculosis, malaria, reproductive health and other categories. Both developed and developing countries import our drugs by virtue of which we are known as the ‘pharmacy of the world.’ Having said that, we still have the challenge of making drugs for chronic diseases and NCDs affordable for our own citizens for which innovation and R&D is crucial.

Hence to achieve the 3 A’s of healthcare, there is a need for developing a comprehensive vision for the pharma industry in sync with the healthcare delivery system. The three key areas that the country needs to focus on are:

Foster the quality agenda for API among manufacturers

The quality of Indian medicines should meet the international standards including Global Manufacturing Practices (GMP) for the domestic as well as export markets. However, some of the recent events have bought to the attention the need for incentivising and promoting quality practices in the API manufacturing in India. There is a need to foster the quality agenda for API among manufacturers including capacity building workshops and Government initiatives for incentivising API production. Some specific issues to be resolved are:

• The existing Indian GMP (schedule M + guidelines) should meet the international standards.
• The issue of shelf life requirement of minimum 60 per cent for API for Import under Advance Licence scheme
• Transfer of API to other Indian companies i.e. Finished formulation manufacturer for product development, solely for export

As a beginning to build capacity and develop common understanding of standards amongst the regulators and Indian pharmaceutical manufacturers, the Department of Pharmaceutical (DoP), GoI in partnership with WHO Country Office for India and FICCI organised three Regional Good Manufacturing Practices (GMP) Strengthening Workshops, focusing on GMP in production of Active Pharmaceutical Ingredients and Oral Solid Dosage forms at Hyderabad, Ahmedabad and Chandigarh. Further, FICCI also organised an industry meet with the visiting US FDA Commissioner, Dr Margaret Hamburg to bring in common understanding between the US FDA, the Indian regulator and the industry. Many more such interactions are needed to keep the dialogue ongoing between the international and national regulators and the Indian pharma industry.

Create an ecosystem for spurring R&D and innovation in India

India is facing the increasing burden of both communicable and non-communicable diseases. According to a global study, in 2010, non-communicable diseases account for 53 per cent of all deaths and 45 per cent of disability adjusted life years (DALYs). Affordable access to generic medicines would be needed for treating diseases like cardiovascular diseases, diabetes, asthma, cancer both in India and around the world. The global industry is highly research intensive and spend around 15 per cent turnover in R&D, however, in India it’s still low with less than two per cent spending. Although the Indian private players have recently increased investments in R&D, however, the focus is on the thriving generics business instead of new drug discovery. As a global player we need to remove this weakness in the system.

Some specific recommendations to spur R&D are:

• Set up a ‘National R&D Observatory’ in India: The Observatory will provide technical support to establish a system to monitor R&D investments and pipelines, recognising the considerable gaps that exist.
• Regulatory reforms for developing new drugs should be based on scientific knowledge, simplified and transparent procedures for speedy approvals
• To ensure flow of funds the weighted tax deduction needs be raised from 200 per cent-250 per cent and should be extended to clinical trials as well
• There should be grants for advanced skill development programmes
• Exemption from excise/ custom duties on raw materials, capital goods and diagnostic kits should be extended

Create a common understanding of Clinical Trials landscape in India

For the new drug discoveries, clinical trials are a must and there is an urgent need to revive the sector to address the burden of existing and new diseases.

India had been a favoured destination for clinical trials in the recent past due to large patient pools, trained physicians well versed in English language, hospitals with modern infrastructure and laboratories etc. However, as we all are aware, the recent Supreme Court rulings have reversed the trend. To address this, the Government has introduced several initiatives to streamline clinical research in the country viz. publication of Indian Good Clinical Practice Guidelines Bio Availability-Bio Equivalence (BA-BE studies) study guidelines, regulatory inspections, introduction of Clinical Trials Registry etc.

However, there are several issues pertaining to BA-BE studies, compensation packages, long processing time due for approvals etc. that needs to be streamlined for reviving clinical trials in the country. Also there is a need for a comprehensive industry-academia mechanism that would result in outcomes with patient benefits at the core of the drug research. And most importantly create awareness amongst judiciary, media and civil societies in order to enable them to take informed decisions.

– Shobha Mishra Ghosh, Sr Director, Federation of Indian Chambers of Commerce and Industry