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OVERHAUL OF DRUG REGULATORS
Trump administration to rejoin offshore drilling agencies separated after 2010 Gulf oil spillThe Trump administration is merging two agencies that were split after the 2010 Gulf oil spill. This move aims to boost efficiency and expe...
Regulating pharma, beyond manufacturing qualityIn a significant leap forward, India's drug authority, CDSCO, is poised for a transformative upgrade. The government is embarking on an ini...
Comments sought on biosimilars guidelinesIndia's drug regulator has released draft guidelines for biosimilar drugs, inviting public comments within 30 days. These revised regulatio...
Indian labs to give 'top priority' to tests on cough syrup exports- RegulatorThe Central Drugs Standard Control Organisation's directive also said laboratories should issue test reports immediately, or as early as po...
Indian pharma to step up quality standard to meet global generic demandIn 2019, Indian pharma companies received 19 warning letters. Nearly half were from the Office of Manufacturing Quality, US Food and Drug A...
The Department of Pharmaceuticals proposes to oversee drug regulatorThe Cabinet secretary had constituted a committee tasked with reforming the drug regulatory system under the chairmanship of Rajesh Bhushan...
Johnson & Johnson case: Parliament panel members lash out at CDSCODrug regulator accused of "criminal negligence" for taking 3 years to issue a medical device alert about the faulty implants.
Government may bring in new curbs on drug prices this monthAmong the changes proposed by the govt is the move to introduce a new price index for pharmaceutical products that will become the benchmar...
Enforcing generic drugs hints at new public health frameworkMonths after the Modi regime took over in May 2014, the Planning Commission was recast and it was left to the new avatar —Niti Aayog — to l...
Pharma Authority won't be dismantled, it will retain powers to fix drug prices: Ananth KumarThis comes even while senior government officials reportedly decided to wind up the authority during a closed door meeting chaired by NITI ...
NPPA will maintain its mandate: MinisterMinister for chemicals and fertilisers Ananth Kumar indicated that National Pharmaceutical Pricing Authority will stay in its current form.
Government may disband National Pharmaceutical Pricing AuthorityUnder the current regime, the moment a drug is brought under the list of essential medicines, it is subject to the price control mechanism.
Wanbury export issue shows regulator miscommunicationThe Maharashtra Food and Drug Administration’s finding that Wanbury shipped to four countries batches of metformin hydrochloride produced b...
Indian drug regulator may scrap licence renewal; move may affect quality of medicinesThe licences and approvals can be made perpetual provided they are not cancelled or suspended by the licencing authority, according to the ...
India’s drug regulator may scrap need to renew licences and approvalsThe government is planning a major overhaul of the country's drug policy, with moves that include scrapping the need to renew manufacturing...
Health: Cheaper drugs, fund infusion to heal this sectorThe biggest challenge would be to curtail rising expenditure on healthcare, most of which is coming out of people's own pockets, thus cripp...
Regulate domestic pharma to be truly world classRegulation of pharmaceutical production in India seems to be stuck in the pre-reform days of autarky, bereft of ambition and oblivious of t...