Appeals by Indian drug firms fail to impress FDA’s Hamburg

Despite the positive notes sounded by the Indian pharmaceutical industry and government officials after the visit of United States Food & Drugs Administration commissioner Dr Margaret A Hamburg last week, reports emerging in the Western media today suggest that the FDA is far from happy, and remains dismissive of drugs made in India.

During the meetings with Indian drug makers, Hamburg said the companies that export medicines to the United States should ensure that the supply of prescription drugs is harmless, secure, efficient and high standard.  She stressed in the meeting with manufacturers and regulators that the quality and standards of the product really matter.

Both sides reached a mutual understanding that the regulation of Indian medicine manufacturers by the US should be administered earlier, as it is very crucial.  The Indian companies will be showing their record to the FDA for approval when exporting medicines to the US.  The FDA has set up an institute of regulation of quality and safety of medicines known as An Office of Pharmaceutical Quality.

Workhardt Ltd and Ranbaxy Laboratories, two leading Indian manufacturers of generic drugs, have been banned from selling their products in the US, since the plants at which the drugs are manufactured use suspect practices.

The FDA deducts yearly fees of $300 million from pharmaceutical companies that export medicines.  The plants were researched three different times in 2009 and 2013, and harmful ingredients were located.  The FDA continuously issued warnings to the companies and Ranbaxy was penalized to pay $500 million.

According to the World Health Organization (WHO), around 20 per cent of Indian drugs are considered bogus and around 12 per cent unauthentic.

India's pharmaceutical industry supplies 40 per cent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.

Investigators from the FDA are blitzing Indian drug plants, financing the inspections with some of the $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants.

The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.

Indian officials and pharmaceutical companies are seemingly shocked by recent FDA export bans of generic versions of popular medicines that the FDA determined were adulterated, suspect that she is just protecting a domestic industry from cheaper imports. However, the Indian drug administrators too have now launched investigations, tardily as usual.

''There are some people who take a very sinister view of the FDA inspections,'' Keshav Desiraju, India's health secretary week, said in a recent interview.

The FDA's increased enforcement has already cost Indian companies dearly - Ranbaxy, one of India's biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. And many worry that worse is in store (See: Ranbaxy fined $500 mn by US regulator over drug safety lapses).

''If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those,'' G N Singh, India's top drug regulator, said in a recent interview with an Indian newspaper.

The unease culminated last Tuesday when, according to The New York Times, a top executive at Ranbaxy pleaded with Hamburg at a meeting along with other drug executives, but without government officials present, to allow his company's products into the United States so that it could garner enough funds to pay for fixes. Hamburg politely declined.

India's drug industry is one of the country's most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class. But others suffer from serious quality control problems.