-The Times of India The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help. The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises...
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WHO clearance will boost Indian vaccine exports -Aarti Dhar
-The Hindu In a major boost to the country’s private vaccine manufacturing pharmaceutical companies, the World Health Organisation (WHO) has said that India’s national regulatory authority — Central Drugs Standard Control Organisation (CDSCO) — and its affiliated institutions meet the prescribed international standards. India is a major vaccine producer with 12 major vaccine manufacturing facilities. These vaccines are used for the national and international market, reaching nearly 150 countries. Every second child...
More »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 »SC concerned over clinical trials of drugs, seeks details
-Deccan Herald The Supreme Court on Monday expressed concern over the lives of people who, without their knowledge, were subjected to drug clinical trials by pharma companies and sought details of the number of such trials and the deaths and adverse reactions caused by them over the last seven years. “We are concerned with the lives of those who become subjects of clinical trials unknowingly and helplessly,” ta bench of Justices R...
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...
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