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Indian pharma: Bad at GMP compliance or victim of unwarranted regulatory expectations?

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Viranchi Shah, Vice Chairman, Indian Drug Manufacturers’ Association (IDMA), opines that India’s role in global healthcare cannot be decimated or questioned only due to recent concerns but cautions that India cannot ignore any international concern on quality, and must do all it can in order to maintain its dominance in the global pharma map

20160531ep49India is world’s biggest source of generics and branded-generic formulations. India caters to the major pharma needs of over 200 countries across the globe. Indian companies have dominating presence in the developing world. Indian products have wide acceptance and affordability in these markets. The Indian share is quite significant in the generic marketsof the developed world, including the US and EU markets. Around 40 per cent of ANDA approved by US FDA are from India. Can a country conquer such massive share and command, if its manufacturers have such a bad GMP compliance culture?

On the other hand, we read about unfavourable comments from regulatory authorities such as USFDA and MHRA after audits of Indian plants. These observations question GMP compliance by some of the leading Indian companies. Most of the red flags relate to data integrity, laboratory controls, investigation systems, training systems, validations and documentation controls. These are common instances of non compliance which are highlighted in several audits, and raise eyebrows about the the overall culture and practices prevailing in India. In the last two years, products from several Indian API and formulation companies have been subjected to some form of restrictions or watch by US and European regulators. Are these regulators over reacting, or do they really have cause for concern? Doesn’t this highlight that something is really wrong with the GMP culture across the nation?

Indian pharma industry is a global player with over 50 per cent revenues coming from international markets. Exports have consistently grown much faster than the domestic business. Today, India exports over $17 billion worth of pharma products annually. A lot of capacities are being expanded and newer ones are being built. Therefore, India cannot ignore any international concern on quality, and must do all it can to maintain its dominance in the global pharma map.

Entrepreneurs must understand that standards are upgraded with every wink. The science is getting more refined each day. Technology brings in newer dimensions. Regulatory expectations are going up every day. When we speak of ourselves as one of the global leaders in the pharma industry, obviously the expectations are even higher. The goal post is changing each day, and we need to continuously change our directions to reach it. The quality or GMP standards are not limited to quality, but are getting more and more complex.

The path to success lies in a proactive approach towards compliance. Companies aspiring to be global, need to bring in the right professional talent from the front door. These talented pool of professionals need to be given the right message- we need proactive compliance. The goal should not be limited to the absence of any form of GMP non-compliance, it should be proactive compliance to the latest GMP requirements. Quality managers need to be thinking about tomorrow.

Investing in the latest technology and talent is a must. Commitment to proactive compliance, not just by way of quality policy but also through actions is more than necessary. Managerial review of quality trends and compliance are critical. Company managements must understand that the cost of non-compliance is much higher than the cost of compliance.

Though there is a lot of talk over GMP compliance, most experts believe that Indian companies have a good track record when it comes to product quality. Most audits do not reveal any serious
concerns on the final quality of Indian products. Indians have also benchmarked affordability of medicines. Indian companies have been succeed due their ability to produce good quality products at very affordable prices, since decades. Indian role in global healthcare therefore cannot be decimated or questioned only due to recent concerns. But yes, the future is bleak if these concerns are not promptly addressed. Those who will fail to address these issues will soon fall into stagnation and decline.

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