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CDSCO LICENSING PROCESS
WHO seeks details from India over oxytocin-linked deaths; licences of manufacturer cancelledThe World Health Organisation (WHO) has sought details from the Indian government after reports linked oxytocin injections made by Jackson ...- Drug companies directed to step up vigil on adverse reactionsIndia's drug regulator, CDSCO, has mandated all drug companies to establish systems for tracking adverse drug reactions. This move comes am...
- CDSCO directs pharmacies to display QR code and toll-free number for reporting adverse drug reactionsThe CDSCO has mandated that all retail and wholesale pharmacies across India must prominently display a QR code and a toll-free number. Thi...
- Biocon chief bats for dual-agency model to fast-track drug approvalsBiocon's Kiran Mazumdar-Shaw suggests a new drug approval system. The Indian Council of Medical Research would handle scientific reviews fo...
- Centre plans new law for stricter quality checks and surveillance of drugs, medical devices, and cosmeticsIndia is creating a new law to improve drug quality and safety. This legislation will give more power to regulators for checking medicines,...
- Centre to bring law for strict quality checks, surveillance of drugs and cosmeticsIndia is creating a new law to improve drug quality and safety. This legislation will give more power to regulators for testing and monitor...
- Centre set to amend rules to simplify drug testing processThe Indian government is amending drug regulations to expedite the approval process for clinical trials and bioavailability/bioequivalence ...
- In major development in pharma, halt order enforced on production and sale of 35 fixed-dose combination drugsIndia's drug regulator, CDSCO, has ordered a halt to the production, sale, and distribution of 35 fixed-dose combination (FDC) drugs due to...
- Parl panel on health: Cos scared to set up units due to CDSCO approachThe Parliamentary Standing Committee on Health and Family Welfare criticized the Central Drugs Standard Control Organisation (CDSCO) for de...
- Opiod row: Aveo Pharma says drug cleared by state authorities; govt says not approvedAveo also claimed it is not the only company in India manufacturing a similar combination product. A recent BBC investigation report allege...
- View: India's pharma giants set sights on superior quality standardsIndia, known as the 'pharmacy of the world,' ranks third in global drug production and supplies vaccines to over 200 countries. With a targ...
- High-risk medical gear makers get more time for licence complianceThe Drugs Controller General of India (DCGI) has announced that manufacturers and importers of high-risk medical devices who have applied f...
- Medical device makers get six-month extension for importsThe Central Drugs Standard Control Organisation (CDSCO) had set the October 1 deadline for bringing ‘class C’ and ‘class D’ medical devices...
- Uzbek cough syrup deaths: Process underway to cancel license of Marion Biotech, says officialAll production of drugs and other activities at the firm's campus in Sector 67 here have also been stopped completely, Gautam Buddh Nagar d...
- Govt forms panel to study WHO report on deaths of 66 Gambian children linked to 4 Indian syrupsThe development comes on a day the Haryana government ordered the halting of drug manufacturing at the Sonipat unit of Maiden Pharmaceutica...
- 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...
- CCPA imposes Rs 10 lakh penalty for misleading ads of SensodyneAn official release on Tuesday stated that advertisements of Sensodyne products which make the claims 'Recommended by dentists worldwide' a...
- Govt draft policy proposes to cut approval timelines for innovative products by 50%The document dated October 25 says it wants to achieve this by nudging all regulators to work together to reduce process overlapping and es...
- High-level government panel suggests single-window system for new drug approvalsThe committee, set up by the cabinet secretary after Prime Minister Narendra Modi sought overhauling of the country’s drug regulatory syste...
- 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...
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