The IPA has initiated discussions with the American regulator to identify common problems

The pharmaceutical industry has been the subject of increased scrutiny by regulatory bodies worldwide and in the recent past, Indian pharma sector too has witnessed more scrutiny. The US FDA (Food and Drug Administration) is one regulator that requires the highest standards of safety and quality and even as an increasing number of Indian companies are attracted to and have a presence in the U.S. market, this also means that the numbers of inspections and defaults are rising.

D. G. Shah, Secretary General, Indian Pharmaceutical Alliance, said that Indian companies accounted for 12 per cent of the warning letters issued by US FDA. “After all, USA accounts for 30 per cent of India’s pharmaceutical exports of $ 3 billion and this is growing at 18-20 per cent per annum.”

In an interaction with The Hindu, Glenn Saldanha, Chairman & Managing Director Glenmark Pharma said the US FDA was unbiased and “is very rational and consistent in how it approaches things across the globe. As India is exporting a lot more to the U.S. now it is risk-based automatically, the vigilance has increased because of the sheer amount of products that we sell to the U.S.”

For Indian companies, 40 per cent or more have been inadvertent offences. While there are signs that the US FDA has become stringent, it is generally felt very strongly that domestic industry must get its act together particularly in compliance systems and must invest more in processes.

Regulatory authorities will also need to make more effort to communicate the rationale of the prescribed processes that are put in place. “Expecting compliance without understanding is futile. The mitigation of risks requires much better appreciation of the drug safety rules and a clearer understanding of the processes,” Mr. Shah said, adding, “The Indian pharma industry has to learn how to adapt with training. On the other hand, the FDA cannot be merely an inspector or a forensic auditor.’’

The IPA has initiated discussions with US FDA to find out the most common problems faced by Indian companies. “We are planning to have a workshop with US FDA faculty and IPA logistical support in the future and this would go a long way in helping bridge the gaps,” Mr. Shah said.

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