Need for better regulatory compliance…

With regard to pharmaceutical drugs manufacturing in India, one can expect more regulatory compliance supervision, especially with the recent establishment of USFDA offices here. Recent incidents have attracted negative publicity (like the generic imports ban) due to noncompliance of GMP from some of India’s leading pharmaceutical manufacturers, but the country will recover from the same.

Research and development…

India now focusses on local innovation, and rightly so, if India’s pharmaceutical industry has to mantain its dominant position in the global scenario. India is now catching up with the global trend and has started investing, leaving behind the reputation as a mere ‘generics’ powerhouse. Today, the country is equally capable of creating and not just reproducing pharmaceutical value. It would be best to seize the opportunities, ie, utilise the West’s inclination to outsource to India. Today, India has well-trained people in clinical research who can speak English and have an open mindset. Therefore, India can collaborate with the US much better than China.

India as an outsourcing destination…

India has the most USFDAapproved facilities outside the US. Major pharmaceutical companies in India are now focussing on complying with USFDA GMP manufacturing requirements for drugs intended for export to the US. India’s prowess in the generic drugs manufacturing world is legendary, which China can only hope for today. For clinical trials, good doctors are available in large numbers in India, while the shortage of clinical research associates (CRAs) to monitor clinical trials studies are being addressed by various clinical research training institutes. Further, we communicate well in English. These are advantages where we outweigh China. The recent negative lapses in the industry such as the Ranbaxy incident can threaten India’s reputation, which must be addressed by better and frequent training on GMP manufacturing guidelines. These incidents happen when the management treats compliance lightly, as they see that there is no need for investing in training manufacturing personnel, or cuts corners in some cases, or flatly ignores GMP regulations in other cases. Further, clinical trial scientific protocol is one of the most important issues in India. Another is the strict adherence to GCP, an area where the country needs more training. Cultural differences and genetic hereditary biases aside, we are all human beings and no clinical trials subject should be treated any differently, no matter where the study is conducted. Major overseas pharmaceutical companies are looking at India for tie-ups or acquisitions. Pfizer plans to acquire Wockhardt; and Sanofi, the French multinational drug company has acquired Merieux Alliance’s majority stake in Hyderabad-based vaccine firm Shantha Biotechnics. India’s leadership position in generic manufacturing has been attracting global M&As. This leads to a fact that India still ‘rules’ the emerging pharmaceutical space.

Need for a local consultancy…

The USFDA regulatory compliance oversight on pharmaceutical or biotech drugs and medical devices is constantly changing, as it delivers its mission, ie, to assure that drugs sold in the US are safe &  effective. For example, the USFDA recently announced new regulations about the acceptability of data from clinical studies performed outside the US. These new regulations apply to studies intended for IND NDA (drug), BLA (biologic) or ANDA (generic drug) submissions. Failure to comply with these new regulations could result in the FDA’s rejection of data and put a product’s approval at risk. On the GMP front, there are new regulations and guidelines intended for biosimilars, ie, the counterparts of generics to biotech drugs including the 12-year patent protection for such drugs in the US. These guidelines are complicated and can be subject to misinterpretation unless one follows them on a regular basis, and eventually go beyond website announcements or consulting locally in India.