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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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India Serves Up Costly Cocktail of Vaccines by Ranjit Devraj

Ignoring widespread concern over the safety, efficacy and cost of pentavalent vaccines, India’s central health ministry has, this month, approved inclusion of the prophylactic cocktail in the universal immunisation programme in seven of its provinces. Pentavalent vaccine doses, a cocktail of five antigens in a single shot, confers immunity against five paediatric diseases - diphtheria, pertussis, tetanus, hepatitis B and haemophilus influenza type b (Hib), with the last one considered particularly...

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Malaria drug, made in India

-The Telegraph An Indian pharmaceutical company has tweaked and tested a synthetic molecule first created in an American university and developed the world's latest drug against malaria, an alternative to standard anti-malarial therapy. India’s Ranbaxy Laboratories today launched the new drug for the treatment of uncomplicated malaria caused by the Plasmodium falciparum parasite, after nine years of research which was partly supported by the Indian government. Clinical trials in India, Tanzania, and Thailand...

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