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2,242 Trial Deaths, Few Rules: India Aims for Regulatory Reform

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By Randy Osborne
Staff Writer

India's Drug and Cosmetics Act purports to keep clinical trials kosher under something called Schedule Y, but the law – which has not been amended since 2005 – lacks rules for mandatory practice and does not specify what recourse trial participants have when things go wrong.

Where contract research organizations (CROs) fit into the picture is not fully explained, though CROs do a great deal of clinical work in India.

India's Ministry of Health & Family Welfare is asking for comment from drug developers and other interested parties on the plan to establish two committees that would "formulate [binding] policy, guidelines and standard operating procedures" for clinical trials and how they relate to approvals, as well as for banning drugs and regulating fixed-dose combinations.

Trials have mushroomed in the country over the past seven or eight years, as biopharma companies have sought to take advantage of the large, diverse patient population, not to mention the regulatory loopholes. Lax oversight also has meant longer times to approval, which could explain something of a slowdown lately. In any case, new scrutiny of the landscape means that few in the industry want to talk on the record about the situation.

The Associated Chambers of Commerce and Industry of India said almost 100 pharmaceutical firms – counting domestic and multinational – were conducting trials in the country in 2011.

Just over a year ago, the activist group Swasthya Adhikar Manch filed a lawsuit over clinical trials and patient safety. In October 2012, the India Supreme Court asked the health ministry to provide details regarding deaths in clinical studies, and matters of conduct related to the experiments.

Through such disclosures and court-related filings, India's media – much more actively reporting on the problem than those in the U.S. – learned that between January 2005 and June 2012, the ministry approved 475 clinical trials for new chemical entities, and recorded 11,972 adverse events, excluding deaths, 506 of which were known to be caused by the trials. Deaths added up to a whopping 2,242.

No more than 1.5 percent of global trials are conducted in India, according to the Indian Society for Clinical Research, but this number could begin to grow at a fast pace as biosimilars hit their stride.

"India anticipates that biosimilars will become the most important economic and therapeutic component of its already robust biopharma industry, which is known for its manufacturing of generic drugs," noted The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies, a new report from BioWorld.

Meanwhile, the India-based Business Standard newspaper reported that its peek at confidential data revealed the specifics of the 2011 death numbers, with 57 patients expiring in trials conducted by Novartis AG, 32 in trials by the CRO Quintiles Transnational Corp., 20 each for Pfizer Inc. and Bayer AG, 19 for Bristol-Myers Squibb. Co. and 10 for MSD Pharmaceutical (the name for Merck & Co. outside the U.S.).

At the start of this year, the country's Supreme Court revoked the authority of the Central Drugs Standard Control Organization (CDSCO), which until then had been the entity in charge of monitoring clinical trials in India. Until the health ministry comes up with a better means of oversight, the court ruled, no further trials could take place.

And now the ministry is asking for input that will help the pair of committees figure out what to do next. The still-vague plan, disclosed last week, came in the form of a brief notice from the Office of the Drugs Controller General.

In 2012, 253 of 480 applications were granted to conduct trials of new drugs or vaccines, compared to 283 (out of 306) granted the year before, according to figures from the health ministry obtained by india.com, a Mumbai-based news source. The number of trial go-aheads went down last year; deaths during trials stayed about the same: 436 last year and 438 in 2011, according to Business Standard.

The 2011 statistics, at least, were down from 2010, when 668 deaths were recorded during trials, but the quantity of clinical studies allowed was also up significantly, to 529.

Last week, India's parliament was informed of six cases of alleged "irregularities" in clinical trials uncovered during the past two years, but critics are worried about what might have escaped notice because of loose or nonexistent rules. The health ministry is taking comments on its dual-committee plan through April 7.

Editor's note: For a copy of BioWorld's new biosimilars report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.