The Union Government has issued a warning letter to Programme for Appropriate Technology in Health (PATH), asking it to be careful while conducting clinical trials so as to ensure that discrepancies and violations are not repeated in future.

The Indian Council of Medical Research (ICMR) had suspended the Phase-V post licensure clinical trial being conducted by PATH, an international non-governmental organisation, in Khamman (Andhra Pradesh) and Vadodara (Gujarat) for Human Papilloma Virus (HPV) vaccine. The ICMR and the governments of Andhra Pradesh and Gujarat were the collaborating partners for a cervical cancer prevention vaccine. However, there were allegations that trials were conducted on schoolgirls in the tribal districts and in violation of the consent rules. As many as 14,091 girls received the vaccine in Andhra Pradesh and 10,686 in Gujarat. The vaccines were donated by Merck & Co., Inc. (Gardasil) and GlaxoSmithKline (Cervarix).

The violation came to light when seven girls who received the vaccine, died following which the ICMR suspended the trial on April 7, 2010.

A committee appointed to probe the “alleged irregularities in the conduct of studies using HPV vaccine by PATH in India” reported certain discrepancies in taking informed consent, the ethics committee’s approval, reporting of serious adverse and monitoring during the trial period.

The warning letter was issued on July 3, Union Health and Family Welfare Minister Ghulam Nabi Azad told the Lok Sabha on Friday.

The House was also informed that of the 1,317 deaths during clinical trials in India in the last three years, cardiovascular and cancer cases accounted for 679 and 431 casualties.

In the current year, 211 deaths were reported. Of this, 82 were in cardiovascular and 66 in cancer categories, while five were cerebro-vascular deaths, 12 anti-diabetic and eight antiviral/anti-fungal category deaths. As many as 38 deaths were due to other reasons.

On the steps being taken to bring in transparency in the system of approving new drugs, Mr. Azad said registration of all clinical trials with the Indian Council of Medical Research (ICMR) was made mandatory since June 2009.

He said 12 new Drug Advisory Committees and six Medical Device Advisory Committees have been set up by the government. Besides, a general experts pool, for medical device advisory committees, has also been set up. Every approval for conducting clinical trials now includes a condition that in case of study related injury or death, an applicant will provide complete medical care as well as compensation and statement to this effect should be incorporated in the consent.

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