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Clinical trials and many errors

The SC on Monday said no human trials of new drugs should be allowed without an audio-visual consent, giving its nod to only five of the 162 drug trials and new fixed-dose combinations – approved by the Centre.

india Updated: Oct 23, 2013 13:21 IST

Sarita and Rajkumar Tiwari’s unnamed 45-day-old son was among the 147 children who died in August 2006 after getting a yet unidentified vaccine at MGM Medical College and Chacha Nehru Baal Chikitsala, Indore.

The Tiwaris took their son for BCG vaccination to protect him against tuberculosis. “But he was vaccinated for something which caused his death within a day of being vaccinated,” said Tiwari, who lives in the Juni Indore area with her husband and two sons.

Sarita said she was asked to sign a document that ran into several pages. “With my child crying after getting three vaccine shots, I was asked to sign quickly and I did, without a clue about what it said.”

The Tiwaris have still got no answers, certainly not from the doctor who was served showcause notice by the state commissioner of departmental enquiries in January 2013.

“The case dates back to 2006, seven years ago. You cannot expect me to remember the case details, he could have died for other reasons, including several neo-natal diseases,” he said.

“Just because we are poor and not educated enough, we lost our son to big people’s experiment,” said Rajkumar.

It’s the stories of people like them that prompted Dr Anand Rai and Swasthya Adhikar Manch, an NGO, to file a PIL, demanding safety for participants — often without consent — in large-scale clinical drug trials by multinational pharmaceutical companies.

On Monday, the Supreme Court said no human trials of new drugs should be allowed without an audio-visual consent, giving its nod to only five of the 162 drug trials — related to new drugs (including new chemical entities) and new fixed-dose combinations — approved by the Centre.

It ordered that clinical trials for the 157 drugs must be cleared by the technical and apex committees set up by the Centre for this purpose.

In India, 2,644 people died during clinical trials of 475 new drugs between 2005 and 2012. Of them only 80 have been compensated. No postmortems were done in any of the cases.

Another 11,972 serious adverse events (excluding death) were reported in the same period. Of those 506 events were established to be linked to the clinical trials, show the Union ministry of health data.

“The Court directed the committees to evaluate the application on the basis of benefit-risk assessment, the new need for the new drug versus the existing therapeutic options, and the unmet need in India,” said Dr Rai, who attended the hearing.

The clinical trials industry in India is estimated at $485 million in 2010 and is anticipated to cross $1 billion by 2016, says Frost & Sullivan’s Strategic Analysis of the Clinical Research Organisation Market in India (2012). Large, easy-to-access, treatment-naive population and a high degree of available cost arbitrage of 30-50% over the US are driving the market, which is growing at 11-13% annually, it said.

“India has 16% of the world’s population and 20% of the global disease burden but less than 2% of global trials take place here. To find better and more cost-effective cures … it is necessary to conduct clinical research in India,” said a spokesperson of the Indian Society for Clinical Research, an association of clinical research professionals.