Health activists from across the country have asked the Union Health and Family Welfare Ministry to take immediate cognisance of the recent report of the Department Related Standing Committee that has criticised the functioning of the Central Drugs Standard Control Organisation (CDSCO) for irregular approvals for clinical trials and sale of medicines to pharmaceutical companies that put patients at risk. In a statement issued here on Wednesday, the activists asked the...
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Doc panel for drug approval
-The Telegraph The Centre today asked a panel of doctors to outline measures to improve drug approval procedures, three days after a parliamentary standing committee said India’s drug regulators had broken laws, ignoring the interests of patients. The panel announced by the Union health ministry has been asked to suggest steps to improve the procedural aspects of the Central Drugs Standards Control Organisation (CDSCO), the agency entrusted with approving medicines for sale...
More »Health ministry underplays parliamentary panel report-Vidya Krishnan
A key finding in the report was that several multinational firms had launched drugs without conducting mandatory clinical trials or seeking expert medical opinion The health ministry has denied the presence of any systemic rot in the drug approval process and pharmaceutical firms have refuted charges of collusion after a report by a parliamentary panel pointed to regulatory lapses in clinical trials. The panel, which looked into the functioning of Central Drugs...
More »Drug cos lay onus of medicine approvals at DCGI door-step
-The Hindu Business Line The onus of granting approvals to medicines marketed in the country is on the regulator Drug Controller General of India (DCGI), say drug companies, adding that they have adhered to the law of the land. The drug-makers were responding to a Parliamentary panel report on health that severely indicted the drug regulatory authority, besides alleging that “invisible hands” of drug-makers were involved in getting favourable reports on medicines...
More »Panel exposes flaws in India’s drug approval procedure-Vidya Krishnan
A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India (DCGI), has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process. The committee has asked the health ministry to withdraw the discretionary powers given to the Central Drugs Standard Control Organization...
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