|Former FDA Commissioner Margaret Hamburg|
Then-FDA Director Margaret Hamburg went to India last year to politely deliver a message to top government and industry pharma leaders: A country that produces many of the world's generic drugs needs to make sure it is fully in tune with international standards. Now a top business organization has warned the Indian pharmaceutical industry about what the FDA has been tacitly indicating for years with product bans and warning letters. If India doesn't get its "house in order," the country is going to suffer the consequences of seeing its pharma industry fall behind.
The warning was laid out in a report issued Wednesday by The Associated Chambers of Commerce and Industry of India (ASSOCHAM), which called on India's pharma leaders to step up their game and on the government to provide more trained pharmaceutical inspectors so that it can. It said the country's 1,500 inspectors are not nearly enough to oversee a country that has 10,000 drug manufacturing facilities. It also indicated another point of contention with the west, a patent system that the report called inconsistent.
"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 report highlighted one of the ongoing 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.
The ASSOCHAM report was released, even as the FDA this 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.
But, as 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 $4 billion acquisition of Ranbaxy Laboratories. Sun's key plant in Halol, while not banned, has had to interrupt production to make improvements after getting an FDA warning letter last year. That has had a significant financial impact on the drugmaker, whose U.S. sales were off 28% in the last quarter, in part because of the ongoing plant problems. Workhardt and Dr. Reddy's Laboratories ($RDY), two other large Indian drugmakers, are also having production affected after the FDA took regulatory actions against them.
Some Indian pharma officials have complained that FDA expectations keep changing and that the country is being singled out by the agency. The FDA has responded that it is just a matter of numbers. The U.S. gets an estimated 40% of its generic and over-the-counter drugs from India, second only to Canada, so India gets more oversight.
The chamber's report also takes aim at India's patent system, which U.S. and European drugmakers have complained loudly about because it often denies or revokes patents on their top-selling meds. It pointed out that India has an unwieldy process, with patent offices throughout India's urban areas that are using their own rules on patents. It said the lack of standards and poorly trained personnel affect quality of drugs in the country.
- read the Times of India story