Major hospitals in Mumbai have stopped using non US FDA and CE certified drug eluting stents (DES) for angioplasty, after Maharashtra FDA decision came early this month to insist either on DCGI’s marketing permission or US FDA or CE approval to market DES in the state, it is learnt.
“At present, only three companies marketing DES in India conform to the quality parameters insisted by state FDA. However, there is no shortage of the product, as companies like Johnson and Johnson (Cypher) and Boston Scientific (Texus) are supplying adequate US FDA approved stents to all the leading hospitals,” said Dr. Anil. K. Sharma, interventional cardiologist with Leelavati and a few other leading hospitals.
Reacting to the comments by the Bangalore cardiologists that Maharashtra’s decision is illogical and would only create shortage of stents, state FDA commissioner Ramesh Kumar said he has not received any complaints about shortage of stents. “Let the Bangalore cardiologists keep their opinion limited to Bangalore. We are just insisting on quality control specifications which are very important for sale and manufacture of any drug,” said Ramesh Kumar.
“Now almost all hospitals are insisting on quality stents. FDA’s decision has neither created a shortage of stents nor pushed up the prices. There is not much difference in cost of US FDA approved stents and other stents. The two widely used brands are Cypher and Texus costing approximately Rs 1.2 lakh and Rs 1 lakh. Other stents cost Rs 70,000- 90,000,” said Dr. Anil. K. Sharma.
He added that the basic difference between US FDA or EU approved DES and other DES is that the latter lack adequate trials and data to show to get international authority nod.
“When DES was introduced in the Indian market for the first time in July, 2002, Central drug authorities had made it clear that DES does not fall under its purview. This action by state FDA should have taken at that time. However, I feel it is a good step even if it is a little bit late. But, US FDA is not the final authority for certifying drugs and medical devices. What is more important is, we should have our own authority. Any drug approved by US FDA or any international regulatory body should also be approved in India,” says Dr. Sharma.
Dr. Suresh Maroli, Associate Professor with LTMC & General Hospital, Mumbai and an expert who had worked on a DRDO project to develop indigenous cheap drug eluting stents a few years ago noted, India should have brought in necessary regulations earlier. “Recent regulatory action by Maharashtra FDA could cause shortage or interruption in supplies. Naturally, doctors will become cautious when regulatory officials decide to look at such products. I am not sure whether the issue has caused either shortage of the product in hospitals,” said Dr. Suresh.