US Food and Drug Administration (FDA) has assured India to help Indian companies to 'identify operational problems' and 'initiate measures for self-correction', but claimed that it adopted uniform standards for all the countries, even as the industry captains raised the concerns about the increased regulatory scrutiny with the visiting US FDA commissioner Dr Margaret Hamburg.
The US FDA also showed interest to enhance and widen the scope of collaboration with the Indian regulatory authority based on the new statement of intent signed between both the sides.
Drug Controller General of India (DCGI) Dr G N Singh is learnt to have pressed for avoiding 'over regulations' and preparing a favourable pitch for Indian generic firms in the US while ensuring patient safety, sources said adding that both regulators had 'fruitful discussion’ covering the entire gamut of regulatory affairs. Both the sides also decided to hold more such interactions between the officials and also hold workshops for the industry in India to make them aware of the norms and laws.
In the closed-door meeting with the industry representatives, Dr Margaret has extended the assistance by the US FDA officials in identifying the operational problems and rectifying them. However, she maintained that the US regulatory had uniform standards for all the countries.
She said that the FDA was in the process of reorganising its structure and speeding up the process of approvals. This would help clear the backlog of inspection for Indian drug manufacturers who have applied for approval from US FDA to export their products to the US. Around 50 per cent of applications are in the backlog for the last 90 days.
Dr Hamburg said that the US FDA office in India has a mandate to conduct inspections of pharmaceutical manufacturing premises and was working towards bringing awareness about US regulatory requirements and standards amongst industry through capacity building workshops. Strong and smart regulation in a clear, predictable and transparent ecosystem creates a level playing field for all players in the market.
Dr Hamburg said that safety, efficacy and quality of the product are the three pillars of the regulatory framework and USA and India need to work in collaboration for getting affordable drugs made available to the patients not just from both the countries but also meet the global requirement. She added that India provides generic medicines to almost 200 countries and is the second largest exporter of generic medicines to the US. Hence, strengthening and extending this relationship was of utmost importance. The focus for both the industry and the regulator should be to keep pace with the changing scenario due to rapid advancements in science and technology that lead to new drug discovery, biosimilars etc. and at the same time new tools for regulators to assess safety, efficacy and quality.
She added that FDA was looking forward to enhancing partnership with its Indian counterparts and working towards bilateral as well as global partnership. There are opportunities for joint training and educational opportunities for sustainable partnership. The US FDA was thinking of ways to involve academia, industry and government, she said.
Dr Habil Khorakiwala, past president FICCI, chairman, Wockhardt Group and also chairman FICCI Life Sciences Council, said that developments in Indian pharmaceutical industry is science based. He further suggested that the Indian regulatory standards need to be aligned with the US regulatory requirements as India is becoming a manufacturing base for some of the generic companies. India is playing an important role in generics and is keeping up with the competitive environment. Also, Indian research will play a significant role in research and drug discovery in future.
A large number of representatives of the pharma and food sectors attended the round-table with the US FDA commissioner. Arun Sawhney of Ranbaxy, Dilip Shanghvi of Sun Pharmaceuticals, Arjun Handa of Claris Lifesciences, Neeraj Aggarwal of Jubilant Orgnosys and Pankaj Patel of Zydus Cadila were among those who met her.