Scores of Indian drugmakers, including India's largest, are having to make plant improvements and change their processes after FDA regulators cited their plants for all sorts of shortcomings. And that is likely to keep happening if the Indian pharma industry, with help from the government, doesn't make some serious improvements, warns a top business group in the country.
The report from the Associated Chambers of Commerce and Industry of India (ASSOCHAM) highlighted one of the continuing issues for the industry, that the country has less stringent regulations for its own drugs than the FDA has for products sold in the U.S. Those companies that do not step up their standards for their exports have found the FDA issuing warning letters and banning imports.
"While at times, the US Food and Drug Administration (FDA) gets into minute details, which have more to do with cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of regulators at national and state levels in sync with the best global practices," D. S. Rawat, ASSOCHAM secretary general, said when releasing the report, according to The Times of India. "However much we may wish otherwise, pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health."
The ASSOCHAM report was released as the FDA last week banned all products from Indian API maker Pan Drugs. The agency issued a warning letter to the ingredient maker in September noting that its facility had holes in the ceiling and pigeons flying around production areas.
The report pointed out it is not just small manufacturers that are being called out by the FDA. Sun Pharmaceutical, India's biggest drugmaker, has 5 plants banned from shipping products to the U.S., which includes four that it got this year in its $4 billion acquisition of Ranbaxy Laboratories. Sun's key plant in Halol, while not banned, has had to interrupt production to make improvements after getting an FDA warning letter last year. Wockhardt and Dr. Reddy's Laboratories ($RDY), two other large Indian drugmakers, are also having production affected after the FDA took regulatory actions against them.
- read The Times of India story