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Most trials conducted under strict FDA, European rules

Most trials conducted under strict FDA, European rules
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First Published: Thu, Feb 19 2009. 10 23 PM IST
Updated: Thu, Feb 19 2009. 10 23 PM IST
Mumbai: India has been a preferred destination for clinical trials ever since pharmaceutical outsourcing picked up at the start of the decade. As the number of human trials increased, the country modified its rules in 2006 to ensure quick clearance for drug investigation projects by foreign companies.
This rapid pace led to concerns on ethics of such trials, especially as many of the drugs are not meant for immediate use in India.
There have also been instances of negligence by researchers and exploitation of uninformed patients.
According to the National Clinical Trial Registry of India, at least 90% of the 662 ongoing trials are registered with the US Food and Drug Administration, or FDA, and European drug control authorities. About 60% of the ongoing trials are in advanced stages involving patients and volunteers; these are known as phase III studies.
Clinical trials are typically sponsored by large pharmaceutical firms such as Pfizer Inc., GlaxoSmithKline Plc., Sanofi-Aventis SA, Bristol Myers Squibb Co., Novartis AG, AstraZeneca Plc. and F Hoffman-La Roche Ltd, and conducted worldwide to generate data on safety and efficacy from different regions.
This is usually done with an aim to register the drugs in other markets as well. A new medicine has to be tried on 2,000-4,000 patients globally.
The ethical issue in recruiting more patients from developing countries rather than from the home nation is debatable, said Arun Bhatt, president, Clininvent Research Pvt. Ltd, one of the top three clinical research organizations in India by clinical trials conducted. “But since most of these trial sponsors intend to market their drugs in the global markets, including the emerging markets, one can’t really allege exploitation of poor counties for drug trials.”
If India closes its doors to clinical trials, it would be difficult to make new drugs available locally as the country is still not capable of developing such drugs on its own, he said.
Multinational drug companies are rushing to India as patient recruitment is faster and cheaper, said a Mumbai-based senior research and development (R&D) executive with a multinational drug firm.
“It doesn’t really mean that the Indian patients are exploited, because most of these trials are done under strict guidelines of USFDA and more often by the ethical guidelines for global trials set by the sponsors themselves,” this executive added, asking that he not be identified because of company policy regarding interactions with the media.
Not everyone agrees. Poor training for researchers and a lack of awareness among volunteers has led to fatalities at times, said Samyukta Ajay, vice-president, Siro Clinpharm Pvt. Ltd, a research body. She suggested the government have a mechanism to negotiate with global pharma companies on making the drugs tested in India available locally at affordable prices.
In India, clinical trials are regulated under Schedule Y of the Drugs and Cosmetics Act. The Indian Council of Medical Research issued new guidelines on ethics in clinical trials in 2006 but these are yet to be made into a law so registration is not mandatory for institutions conducting clinical trials.
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First Published: Thu, Feb 19 2009. 10 23 PM IST