)
Even as major Indian drug companies continue to make news for impurities in the medicines they make and faulty – or if the USFDA is to be believed, falsified – data that many generate after testing of samples show quality problem, it seems strange that domestic authorities are silent onlookers. The Indian drug industry is estimated at around Rs 80,000 crore, and is a powerhouse of generic medicines (sometimes referred to as copycat medicines).
While the US Food & Drug Administration (FDA) found black fibre suspected to be human hair in some drug samples, traces of machine oil in tablets, flies and waterless toilets at Indian pharma facilities in the recent past, such impurities and violations have not prompted the health ministry or the drug regulator in India to take any decisive action. This could be because many within the system believe that the phenomenal growth of Indian pharma exports to the US and Europe is perhaps the real reason for companies like Ranbaxy, Sun Pharma, Dr Reddy’s and others coming under the scrutiny of international regulators.
Fear of competition from a large number of Indian companies selling medicines at cheaper prices in the US and European countries could well be a reason why the domestic drug industry is facing import alerts more than players from other regions.
But that alone should not make the Drug Controller General of India (DCGI) take a lenient view of quality concerns raised by international regulators at the country’s pharma manufacturing facilities, which produce medicines for the world. That India is the largest overseas source of medicine to America and that the country’s pharma exports to the US grew 30% to cross the $4.2 billion figure should make domestic regulators more responsible.
Besides the US, import alerts have been growing from the European nations of late. In the latest instance, Ranbaxy, which is in the process of being acquired by Sun Pharma in a $4 billion deal, has been banned from supplying injectable antibiotics to the European Union after its Dewas plant (Madhya Pradesh) failed an inspection. Earlier, German authorities had also found fault with the unit and barred imports. None of Ranbaxy India plants supply to the US anymore after a series of FDA alarms going off. Among others, Sun Pharma too is facing quality issues in some of its plants including the Karkhadi (Gujarat) facility.
The Drug Controller of India had earlier cited its limitations in resources as well as difference in Indian and American quality norms while talking about the scrutiny that pharma companies are facing. In an interview to Business Standard in January 2014, Drug Controller General GN Singh had said India market was not yet ready to follow global standards. While he had promised strict action, even banning products if required, he had made an admission. “If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those.” While the Indian regulator has a total staff of 650, the USFDA has 20 times more at 13,000, Singh had pointed out.
That was almost an year ago. Hopefully, the Narendra Modi-led government, which has often showcased healthcare as a priority area, will do something to clean up the sector and its name in the global arena.
(Nivedita Mookerji covers the pharma and health industry for Business Standard)
