Paying For Death: Untested Medicines In Wide Circulation

Normally, when a drug needs to be launched in India, authorities seek approval of experts; clinical trials may also be conducted, which in some cases may be waived off. That’s happening way too often these days; so much so that the drugs that have been banned in other countries might just be being used extensively in India. The Parliamentary Standing Committee on Health and Family Welfare has some shocking revelations to make about the functioning of the Central Drugs Standard Control Organisation (CDSCO) – headed by the Drugs Controller General of India (DCGI):

• Letters related to the approval of Cipla's pirfenidone drug were received by the DGCI from four different sources on the same day and recorded under consecutive reference numbers
• Regarding clevudine’s (drug marketed by a company known as Pharmasset) approval, three experts from AIIMS (Delhi), KBN Medical College (Gulbarga) and R.G. Kar Medical College (Kolkata) sent identical letters to the DCGI
• For Sertindole (an anti-psychotic drug manufactured by a Danish company) experts from three extremely reputed medical institutes sent recommendation letters in nearly identical language (with incorrect full form of the DCGI in the address)
• In some cases, the letters seeking approval (running into hundreds of pages, with scientific facts and data) were approved in a single day
• In some cases, recommendations were issued even when the drug in question was banned in the US, Europe, Canada, Australia and much of the developed world. No doubt, our leaders flock to foreign shores for their treatment, for they run the risk of tasting their own medicine here
• The final approval letters for many drugs, currently in wide circulation in India, are missing from records. You guessed it right – most of those drugs are banned abroad

You may not be into thrillers and conspiracy theories, but it is too obvious that all these cannot be just coincidences. We all know how doctors are rewarded with expensive gifts and funded trips to exotic locations for recommending certain drugs, but the involvement of some statutory body is surely a warning signal – a big one at that. And we all thought it was only limited to variance in prices of medicines recommended by doctors at private and government institutes! Guess what; we might just be popping wrong pills – the ones that do more harm than good! So, in a way, we are funding trips of these corrupt individuals, and we pay not just through money, but through our health, too.

Correct Way To Approve A Drug

Usually, after a drug is developed, it is run through extensive trials involving animals, humans and simulation-based experiments. Not all drugs approved abroad may be suitable in India, due to different ethnic profile of Indians; it is, therefore, patently erroneous and unethical to introduce a drug in India, just because it works on the patients in the US.

Alas, here, those drugs are being introduced that are banned elsewhere. Between January 2008 and October 2010, shockingly, a total of 33 drugs were approved without clinical trials in India. Some concessions for Phase III trials were to be given to fight emergent epidemics like SARS and Bird Flu in these years, but to our surprise, none of these 33 drugs belonged to that category. A clear case of blatant twisting of rules to suit vested interests!

A Wrong Body?

Go through the website of the CDSCO and you are shocked to read their mission statement, which reads totally servile to the drug industry. They say that their mission to “meet the aspirations demands and requirements of the pharmaceutical industry”.

They are doing a pretty good job at realizing their mission then.

The Danger Within

It’s not that clinical trials, when conducted, are conducted properly. Many such facilities are not fully equipped to deal with emergency situations, like adverse drug reactions. No wonder, pharma companies are finding it convenient to outsource clinical trials to India; after all, the life of poor Indians is cheap, and their leaders readily sell them.

We don’t speak without numbers. The numbers of serious adverse events (SAEs – the events during clinical trials that can cause complications) have been far too many. In the last three years (starting from 2008-09), respectively, 637, 668 and 438 people died due to SAEs. Sometimes the trials were conducted without due permission; thankfully nobody died – hence no compensation was paid to hapless humans working as guinea pigs! Yes, sometimes doctors are fined for not doing their job properly, but the fine happens to be the tune of Rs. 5,000. Human life sells for $100 in India; we have the second largest population, anyway – don’t we?