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CDSCO GUIDELINES
The hidden cost of looking better: What health insurance covers, and what it leaves you to payRising demand for weight-loss drugs, cosmetic procedures and wellness treatments is creating a growing out-of-pocket healthcare expense cat...- Drug regulator drafts guidelines on high-risk solvents after tainted syrup deaths in kidsIndia's drug regulator is creating new rules for dangerous solvents in children's medicines. This follows tragic deaths linked to contamina...
- Drugmakers must report safety data from launch date, not approval date: CDSCOIndia's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be su...
- Drug regulator cracks down on delayed safety reporting by pharma companiesIndia's drug regulator CDSCO has issued new rules for drug safety reporting. Companies must now submit safety reports from the actual launc...
- Testing of drugs from some nations easedThe government has decided to reduce the frequency of testing for drugs imported from certain countries, provided their samples have not fa...
- CDSCO waives local trials for drugs approved in major marketsThe Central Drugs Standard Control Organisation (CDSCO) has decided to waive local clinical trials for certain drugs approved in select ICH...
- CDSCO issues sampling guidelines to ensuring quality and efficacy of drugs, cosmeticsCosmetics samples were not collected in some regions. There is no centralised database of sale outlets where "not-of-standard" quality (NSQ...
- NITI Aayog recommends Indian standards of drug regulation to be on par with global standardsThe apex public policy think tank of the central government also suggested creating a separate authority to regulate medical devices in the...
- Prescribe, formulate a drug recall lawIndia must quickly formulate a law backed by Parliament for recalling medicines that are found to flout GMPs or contain adulterated active ...
- Biocon Biologics denies bribery charge; says it follows due regulatory process for product approvalsThe CBI has arrested Joint Drugs Controller S Eswara Reddy, Associate Vice President of Biocon Biologics L Praveen Kumar and three others i...
- Guidelines on Covaxin for under 18 don't mention EUL by WHO: Health MinistryThe guidelines issued by the Ministry on December 27, 2021, under the heading “New beneficiaries aged 15-18 years” state that "For such ben...
- Moderna's COVID-19 vaccine may soon get regulatory approval in IndiaModerna has also informed that the US Government has agreed to donate a certain number of doses of the Moderna COVID-19 vaccine through COV...
- Foreign produced COVID-19 vaccines: Decision on emergency use applications to be taken in 3 daysThe Central Drug Authority, CDSCO, will process applications for registration certificates (registration of overseas manufacturing site and...
- Telangana bats for Indian vaccine industry, wants Centre to clear bottlenecksKT Rama Rao, in a letter to the union health minister Harsh Vardhan, on Thursday appealed to constitute a high-level empowered committee wi...
- Kool-ex cold chain bets on changing pharma distribution guidelinesThe cold chain logistics industry expects these guidelines to kick-in before the end of 2019.
- 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...
- Rabbits may soon be spared from clinical tests in IndiaThe Central Drugs Standard Control Organisation (CDSCO) has constituted a committee to give recommendations for necessary action in the mat...
- Changes proposed in norms to speed up approvals for biosimilarsBiosimilars are copies of complex drugs based on living cells. They are different from chemical-based generic drugs, which are 'identical' ...
- From October 1, all imported cosmetics to be regulated for safetyGovt has cleared draft guidelines that bar sales of imported cosmetics unless manufacturers get them registered with CDSCO.
- Deadline to import med devices extendsThe government has given 60 more days to importers of medical devices to apply for registration of these apparatus like stents.
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