-The Hindu The 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...
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Herbal oil ads: Govinda tells FDA he was unaware of laws
-Mid Day Last month, the Food and Drug Administration (FDA) had filed 67 complaints at police stations across the state under various sections of the Drugs and Magic Remedies (Objectionable advertisements) Act, 1955. These include complaints against advertisements of products such as 'Sandhi Sudha plus', 'Step up herbal oil' and 'Power Prash', which are promoted by leading Bollywood stars. The FDA had lodged complaints, demanding action against the drug manufacturers, scriptwriters and...
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 »1144 Deaths During Clinical Drug Trials in 2 Years: Govt
-PTI Clinical drug trials in India led to the death of 1144 people in 2010 and 2011, the government today said. The number of people dying during such trials also include 1106 people whose death could be attributed to diseases like cancer, terminal illness or various unrelated causes which is also known as Serious Adverse Event (SAE) of death, Health and Family Welfare Minister Ghulam Nabi Azad told the Rajya Sabha. "The number...
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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