With Indian-made generics accounting for a US market share of over 25 per cent, it is not surprising that it is gaining significant mindshare of the Food and Drug Administration ( FDA). The spate of quality issues with leading Indian pharmaceutical companies in the past couple of years however should not be viewed in isolation. Big Pharma in the West, too, has been facing increasing flak from the FDA and other regulators over good manufacturing practice ( GMP) violations. High profile names like J& J, Genzyme (Sanofi), GSK, Sandoz, Watson, Teva and many others have encountered their share of quality problems and have been served with ‘warning letters’ from FDA.
The real issue is of quality medication – and how we can ensure that every tablet or dose whether for home or overseas markets is of the highest quality. This is important since India has already taken its place at the high table of the global generics market with around $15 billion in exports expected to increase to $20 billion by 2020. Instances of GMP violations stem from negligence. Indian companies need to put in place checks and balances to prevent such slip-ups.
Non-compliance is not new to the global pharma industry. It is due in part to the stringent and diverse regulations across markets that require compliance. The FDA is a highly vigilant regulator that relentlessly pursues non- compliance action against a large number of companies all over the world. Given our fast growing share of the US generics market, the FDA has naturally been conducting inspections in India more assiduously and frequently. This has resulted in several notices being issued to Indian companies. Compounding this is the hefty fine levied on Ranbaxy for a past breach in compliance.
Several factors have led to this crisis in Indian pharma. One is there are too many regulators and policy makers. Regulation and policy is governed by the ministries of health as well as chemicals and fertilisers. For biopharma companies, in addition to these, there is the Department of Biotechnology and the Ministry of Environment. Manufacturers thus have to comply with overlapping, and at times contradictory directives, from three different departments. At the policy-making level, a single ministry for the pharma sector is one way forward.
Then, there is a huge gap between small and large companies based on quality testing and automation in manufacturing infrastructure. This by itself creates quality issues and it is vital to ensure that we bring pharmaceutical manufacturers irrespective of size, under the ambit of common quality standards.
While the industry needs to heed the writing on the wall, there is much that government can do to redress the situation. To start with, we need uncompromising regulation along the lines of the FDA. The issuing of manufacturing licences should be strictly regulated and the frequency of spot audits stepped up along with severe penalties for non- compliance. Rigorous training programmes for regulators of at least one year should be instituted and made compulsory. It is important that approval and regulation be conducted by people who thoroughly understand compliance requirements including quality, efficacy, immunogenicity and GMP – not just the quality standards handbook. Clearly, the government needs to look beyond its technocracy to induct experts with wider exposure to manufacturing and compliance.
For all the challenges however, I believe this crisis is a huge opportunity to develop a new regulatory path – one with a global standards quality framework and implemented with zero-tolerance regulation.