Frivolous contentions of US FDA under pressure from domestic pharma lobby

The warning recently issued by the US FDA to leading Indian generic drug manufacturers on regulatory issues, is rather intriguing, to say the least. There is no denying that it is taking action against US companies also, but the timing, rapidity and regularity of the accusations and selection of the topmost and internationally reputed and respected Indian pharmaceutical companies, does create a doubt regarding the real reason behind the sudden onslaught.

The US FDA commissioner who visited India last February said that the product safety was its top priority and that it would take any action deemed necessary to protect consumers. It is indeed surprising that the US FDA, a super professional Regulatory Body, unparalleled in the world, woke up to this ‘grave problem’ in 2013-14 when the same companies were supplying the same generic medicines to the citizens of the United States since decades.

Did a cardiologist have to inform the senators of the dangers of using sub standard Indian generic medicines? according to sources, he informed the senators that sometimes an Indian generic works and sometimes it does not and he has to put his patients on another well known US manufactured generic drug brand. I wonder, if he would be able to substantiate his claim by showing such records of his patients, which are at least 4-5 years old, to the same senators, to substantiate his claim.

What was the US FDA doing when the Indian pharmaceutical companies, now being persecuted on frivolous grounds like storage of documents etc, first started making their presence felt in the US market? Surely, the quality of the Indian generics should have been a lot worse, more than a decade ago.

If the US FDA would have raised a hue and cry then, as they are doing now, their professionalism would have been acknowledged without any doubt. It is now patently and logically clear that it is making these ‘lame’ to say the least, and belated charges on the quality of Indian generics only because of pressure from the US Pharma Research and Manufacturing Associations.

The Ranbaxy whistleblower blew his whistle years ago. Why did the US FDA not act immediately then? They did not have to wait till 2012 for the US Congress to give it authority to collect fees from the Generics Industry, to increase overseas inspections. It could have had the company’s suspected drugs tested by government approved testing laboratories in the US and published the results and immediately banned the company’s manufacturing sites in India, instead of doing it a decade later and questioning the Indian drugs control regulator’s efficiency now. If this is not a case of the Pot calling the Kettle black, what is?

I am sure, the lives of millions of American patients, who would have then been switched from Indian generics to safe US manufactured copycats or branded medicines, would have been saved. A move which is endorsed by the  cardiologist who conveyed as such to the US senators a few days ago.

He also said. “If you talk to individual cardiologists about this they’ll say ‘yeah, I had a few patients that this didn’t work.’” (sic). It would be immensely useful and tremendously add to his credibility, if he would care to share the names of the specific cardiologists who told him that generic heart drugs did not work on some of his patients and if they would be able to produce their patients documents before the senate and the US FDA, if not the Drugs Controller General of India?

The Associations of Multinational Research & Manufacturing Companies have been trying most unsuccessfully, to impose their will since decades, on the Indian Government viz. on IPR issues, data exclusivity, FDI in pharmaceutical industry & biosimilars, to name a few.

This frustration led certain governments to resort to unlawful detention and seizure of Indian generic drugs consignments exported to other countries legally, at their ports, while in transit, under the specious plea that it violated their IPR laws. So much for their own adherence to regulations and laws.

Now that the profits of the western pharmaceutical industry have dwindled to unacceptable levels and they are at their wits end, they are now pressurising the US Senate and the US FDA to step up the pressure to enforce their will on the Government of India, the Indian Pharmaceutical Industry and the Drugs Controller General of India, in particular.

After all India supplies about 40 per cent of generics and over the counter drugs (OTC) to the USA. Since the US FDA has now come under tremendous pressure, it is now working overtime to wriggle out of the sticky situation it now finds itself in, by making frivolous accusations against the Indian regulatory authority and companies, like not storing document properly etc. If 40 per cent of Indian generics are consumed by millions of Americans since more than a decade, then surely a thousand if not hundred thousand Americans should have lost their lives and hundreds of such cases should have been reported in the live wire US print & electronic media. One last nail in the coffin of accusations would not be out of place.

The MNC pharmaceutical associations have been trying to convince the Indian health authorities and the Drugs Controller General of India, that it is impossible to duplicate a biologic drug, i.e. manufacturing  biosimilars, because they are very large molecules and if at all they are manufactured they cannot be without impurities, which reduces their efficiency and if at all the DCGI gives permission then these drugs should have different generic names.

Would the US FDA or for that matter the MNCs care to explain why several MNCs are getting their biologic drugs manufactured in India now, by Indian Generic Pharmaceutical Companies? And that too, when the cost of manufacturing a biosimilar drug in India is higher than getting it manufactured in the United States, as confided to the author by one of the senior most executives of such an MNC operating in India.