-The Hindu The proposal to extend the time limit for State-level drug regulatory approvals from four to 10 years could hit the generics market In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug...
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Hospitals, chemists to wait for regulatory word on Ranbaxy
-PTI Drug regulator DGCI is conducting a "focussed scrutiny" of medicines sold by Ranbaxy and some other drug makers, but says it remains confident of the quality standards of Indian medicines despite concerns raised by US authorities over some of Ranbaxy's products. While the company continues to assert that its drugs meet all regulatory standards, a few hospitals and pharmacies have adopted a cautious stand on use of its products. However, a majority...
More »Ranbaxy's dark chapter-Bhupesh Bhandari
-The Business Standard Why have Indian authorities woken up to the Ranbaxy case only now? The matter had been simmering for several years The Ranbaxy affair is one of the darkest chapters of India's business history. The company has admitted it fudged data so that it could launch its products in the United States. It has now paid $500 million as a penalty to settle the case. It is worse than Ramalinga...
More »Pharma companies to compensate for clinical trial death, injury
-The Economic Times Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban. The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials. A senior government official said...
More »Centre planning major changes in rules for clinical trials
-The Hindu Drugs Controller must be told of adverse events within 24 hours Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and...
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