-Live Mint Court says legal, ethical issues involved; directs govt to monitor and regulate clinical trials of all experimental drugs The Supreme Court directed the health ministry to monitor and regulate all clinical trials of experimental drugs in the country until further notice and observed that unregulated trials have caused “havoc”. The apex court order on Thursday revoked the power of the Central Drugs Standard Control Organization under the Drugs Controller General of...
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The dark underbelly of India’s clinical trials business-Malia Politzer and Vidya Krishnan
-Live Mint Incidents at Bhopal and Indore highlight irregularities and ethical violations in some trials In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials. Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10...
More »Clinical trials: Regulating chaos-Vidya Krishnan and Malia Politzer
-Live Mint The first in a two-part series examining the opaque world of clinical trials in India A hospital in Indore has been able to get away with unethical medical trials in which 32 people have died over five years, according to the state government. This despite several investigations, a state government ban and Supreme Court strictures—a classic example of the lawless nature of the clinical trial business in India. Lata Mehra, who...
More »Maharahstra, TN account for 36% of sub-standard drugs -Kounteya Sinha
-The Times of India Almost one in three drugs (36%) found "not of standard quality" from across India last year were from Maharashtra (23%) and Tamil Nadu (13%) alone. Around 9.2% of the rest of the sub-standard quality drugs were from Kerala, Gujarat (8.5%), Karnataka (7.2%), Uttar Pradesh (6.9%), Jammu & Kashmir (6.08%) and Rajasthan (5.8%). Union health minister Ghulam Nabi Azad said on Tuesday that of the 48, 082 drug samples tested...
More »CDSCO drafting new norms for financial compensation-Mahim Pratap Singh
-The Hindu In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases. The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000. This makes 2011 only the second year, for which data are...
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