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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...

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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...

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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...

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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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Ranbaxy's finest hour

India joins global drug discovery league The launch by Ranbaxy last week of Synriam, a new drug to treat malaria, is an important milestone. Having made its name by manufacturing generic (off patent) drugs cheaply, India’s pharmaceutical industry has struggled to achieve original drug discovery since the Uruguay Round of trade negotiations signalled the onset of product patents in India. It began to be realised, in time, that there was...

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