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DRUG APPROVAL TIMELINES
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...10 May, 2026, 10.51 AM IST- 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...08 May, 2026, 11.47 PM IST
- Overhaul of drug regulator begins with recruitment plan for 1,500 specialistsIndia's pharmaceutical landscape is on the verge of transformation! The country’s drug regulatory body is gearing up for an overhaul with t...06 May, 2026, 01.13 AM IST
- Drug applications with unanswered queries to be rejected within 30 daysThe message was conveyed through a public notice issued by The Central Drugs Standard Control Organisation (CDSCO) on May 4. It said applic...06 May, 2026, 01.09 AM IST
- What is mifepristone, and why is it used? Court restricts abortion access by blocking mailing of abortion pill in USWhat is mifepristone, and why is it used? A federal appeals court has restricted access to mifepristone by blocking mailing of prescription...02 May, 2026, 04.37 AM IST
- Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.01 May, 2026, 11.26 AM IST
- Dr Reddy's gets nod to roll out generic oral semaglutide drug"The formulation was clinically evaluated in a head-to-head comparative study conducted in India, which established the non-inferiority to ...16 Apr, 2026, 07.31 AM IST
- Funding for innovations key for India to remain vaccine leader: Cyrus PoonawallaSpeaking to ET after receiving the Lifetime Achievement Award for 2025 as part of the ET Awards for Corporate Excellence, Cyrus Poonawalla,...16 Apr, 2026, 01.14 AM IST
- Iran war impact: Essential drugs may cost up to 5% more, for nowThe immediate net consumer impact could be 3-5% higher prices, or roughly similar to what consumers paid before the late-September cuts in ...15 Apr, 2026, 06.00 AM IST
- Drug regulator halves approval timelines, eases several rulesIndia's drug regulator has significantly accelerated innovation by cutting approval timelines by over 50%. Clinical trial approvals now tak...14 Apr, 2026, 12.42 AM IST
- India's 'Mounjaro brides': Weight-loss injections become part of pre-wedding preparationWith wedding season in full swing, Indian health clinics are rolling out specialized weight-loss packages that include popular drugs such a...03 Apr, 2026, 02.24 PM IST
- CDSCO to create 1,500-member scientific cadre to fast-track drug approvalsThe Central Drugs Standard Control Organisation (CDSCO) plans to create a 1,500-member scientific cadre to speed up drug approval timelines...24 Feb, 2026, 12.18 AM IST
- Timeline: How India's coronavirus vaccine got approved by drugs expertsCOVAXIN has been developed by Bharat Biotech, a company based in Hyderabad, with backing from the state-run Indian Council of Medical Resea...03 Jan, 2021, 05.06 PM IST
- 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...21 Jul, 2020, 09.09 AM IST
- Government looks to fast-track approvals for clinical trialsThe central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisat...14 Oct, 2016, 01.12 AM IST
- Health ministry invites views on easing the drug regulation processThe ministry asked associations from both industries to provide suggestions and comments on how to improve the process of approvals and cle...17 May, 2016, 04.03 AM IST
- US generic drug approval delays hit growth plans of Indian FirmsThe Generic Drug User Fee Act (GDUFA) in the US was proposed to expedite the approval of generic drugs on collecting higher fees to process...02 Dec, 2014, 08.55 AM IST
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