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India's Top Court Takes Control as Trial Regulations in Flux

By Zachary Brennan , 24-Jan-2013
Last updated the 25-Jan-2013 at 10:15 GMT

Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme Court order seeking answers on their alleged lax oversight of trials.

The Supreme Court rejected an initial government affidavit on how it was handling an overhaul of clinical trials in India, according to a court order from Jan. 3.

The government’s affidavit was written by the Deputy Drugs Controller of the Central Drugs Standard Control Organization (CDSCO), but the Supreme Court said it “deserves to be ignored” because it was not filed “in compliance” with a previous order from the court from Oct. 8, 2012. That order criticized CDSCO for deaths in clinical trials and how they were being approved.

If you read the [January Supreme Court] order there are none of the severe admonitions…as reported in the media - most of the admonitions were oral observations,” Chinu Srinivasan of the All India Drug Action Network told Outsourcing-Pharma.com. CDSCO's affidavit "was quite damaging” in terms of what it said about the trial industry, he added.

The order from Jan. 3 concluded that until further notice, all clinical trials of new chemical entities "shall be conducted strictly in accord with the procedure described in Schedule 'Y' of Drugs & Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health & Family Welfare, Government of India."

The Supreme Court is serious about cracking down on illegal clinical trials and “has also seen very closely the gaps in the laws,” Amulya Nidhi, a spokesman for the non-governmental agency Swasthya Adhikar Manch, told Outsourcing-Pharma.com. He added that new guidelines will not be the only way to solve the problem – “strengthening the regulations and transparency is important.”

Deadlines

But despite the end of January deadline for another affidavit from CDSCO or the Ministry of Health, there does not seem to be a deadline for CDSCO to issue or finalize new guidelines for how clinical trials should be conducted in India or a deadline for when the current law governing trials should be amended.

John Lewis, a spokesperson for the Association of Clinical Research Organizations, described the situation of clinical trials in India to Outsourcing-Pharma.com as frustrating.

We’ve been going through the rulemaking processes and the regulators have been receptive but most of the rules have not been finalized.” It’s also “very unclear who is making the rules and who’s responsible for enforcing them,” Lewis said.

He also downplayed India’s role in the global industry of clinical trials, noting, “A lot of attention is paid to India because of the potential but India only accounts for about 3% of global trials.”

Indian government officials previously told us that it would tighten regulations governing the trials industry, noting that ethics committees, CROs and clinical investigators would be registered.

Media Reports

Another issue is that media reports coming out of India on clinical trials have been innaccurate and exaggerated.

A CDSCO staff member who declined to be named told Outsourcing-Pharma.com that a recent media report saying that the agency had halted all new clinical trials for at least two months in India is not accurate. He said that the Drugs Controller General of India has not stopped new clinical trials.

Jay Taylor, vice-president of international affairs at the industry group Pharmaceutical Research and Manufacturers of America, last week criticized media reports on clinical trials in India, noting that “much of the characterization of the clinical trial environment has been sensationalized.”

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