On the sidelines of the Bio Asia event in Hyderabad, BIRAC MD Jitendra Kumar says biotechnology department is planning the sandboxes to 'reduce regulatory uncertainty'.
Last year, an ICMR panel even considered recommending all-India ban on popular painkiller amid concerns it could cause liver damage, which could turn life-threatening in some cases.
Drug regulator through executive order issued last August paved way for direct launch of certain categories of drugs approved in select countries by means of local clinical trials waiver.
First launched in Italy in 1985, Nimesulide is available in India under brand names like Nimuwin, Nimutab, Nimopen, Nisulid, Nimdase, Nodard Plus, Nicip, Nimcap, Nicip-P and Nimupain.
In 2019, evidence showed that an impurity in drug degrades over time to form probable carcinogenic compound. Ranitidine is sold as heartburn medicine under names Rantac, Aciloc & Zinetac.
This new proposal, being considered by CDSCO, comes in response to concerns over antimicrobial resistance emerging as a massive public health challenge across the globe, including in India.
Underlining need for more accountability, experts also stress that govt data does not include fixed dose combination drugs, which account for over 40% of drugs sold in India.
Aluminum prices, already rising before the conflict, have gained further as traders and buyers focus on the potential for tighter markets and shrinking global inventories.
It’s easy to understand why the government can’t speak the hard truth. When this war ends, as all wars do, India’s interests will lie with both the winner and the loser.
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