-The Hindu CDSCO sends letter to manufacturers Alerted by the Union Health Ministry’s pharmaceutical watchdog, the National Co-ordination Centre of the Pharmacovigilance Programme of India (PvPI), on adverse reactions that were being reported from some commonly-used antibiotics, the Central Drugs Standard Control Organisation (CDSCO) has now asked manufacturers to ensure that this information be made available to the general public. CDSCO has written to drug manufacturers, to mention in leaflets inserted into drug...
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88 clinical trial volunteers died in 4 years due to direct side effects: Health ministry data -Sadaguru Pandit
-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,...
More »'Many combination drugs not approved by regulator' -Afshan Yasmeen
-The Hindu Study raises safety, efficacy concerns; call for ban of irrational formulations Of the 110 anti-TB (tuberculosis) Fixed Dose Combinations (FDCs) available in India, only 32 (less than 30%) have been approved by the Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator. In the case of malaria FDCs, only eight out of 20 (40%), have been approved. These statistics, that give rise to safety and efficacy concerns, have been brought...
More »Law on medical devices has waited 12 years -Ritu Sarin
-The Indian Express NITI Aayog meeting notes it will bring in ‘more control, curb growth’ New Delhi: Successive governments in India have neglected the medical devices sector. For over 12 years, a proposed legislation, the Medical Device Regulation Bill, has awaited enactment. Advertising The Bill was first drafted in 2006 when the UPA was in power. It was never legislated. Under the NDA, a Group of Ministers (GoM) was constituted under Finance Minister Arun...
More »Not consulted on scrapping drug pricing agency: Chairman -Vidya Krishnan
-The Hindu New Delhi: Days after it was revealed that the Centre is likely to dismantle the National Pharmaceutical Pricing Agency (NPPA), its chairman said the decision was ‘rushed’ and the agency was not consulted. “There were two meetings and the NPPA was not a party to them. Both meetings were held at short notice. This has been a rushed decision. For any policy change, there needs to be consultation. I understand...
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