-Hindustan Times With little transparency on how such deaths are investigated, and new rules relaxing how Clinical Trials are conducted in India, this data could be a poor estimate, said experts. Mumbai: At least 1,100 people who took part in Clinical Trials over the past four years have died, and 88 of these deaths were caused by direct side effects of the trials, the health ministry told the Rajya Sabha last week. But,...
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No safety trials on Siddha, Unani, Ayurvedic products
-Deccan Chronicle Ayush ministry states that experience and evidence of effectiveness of these drugs is based on textual rationale and published in literature. Hyderabad: Fraudsters would flourish if patented or proprietary Ayruvedic, Siddha and Unani products are given licence without insisting on safety trials, industry experts and medical professionals have stated. The Centre has issued drug regulators in states a directive to issue licenses to patented and proprietary products of Ayurvedic, Siddha and...
More »WHO tells govt strict clinical trial rules will drive away drug firms -Teena Thacker
-Livemint.com WHO says the Indian govt should ‘reconsider’ the compensation clause because an approval to the rules in the current form would affect the conduct of Clinical Trials in India New Delhi: The World Health Organization (WHO) has told the central government that the United Nations (UN) agency’s work with India would be “hampered” and drug companies driven away if the government goes ahead with stringent draft rules for compensation in case...
More »To market new drugs in India, global trials must include Indians -Sushmi Dey
-The Times of India NEW DELHI: In a move to ensure efficacy of medicines sold in India, the drug regulator has made it mandatory for companies to include Indian patients in global Clinical Trials if they want to market in India a new drug developed outside the country. The decision was taken in a recent technical committee meeting, headed by director general of health services Jagdish Prasad. The committee, which was formed...
More »Generic medicines in a digital age -Dinesh S Thakur & Prashant Reddy T
-The Hindu We need a legal mechanism to ensure that all generics are of the same standard as the innovator product The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug,...
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