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DRUG MANUFACTURING COMPLIANCE
Death in a vial: Five cases lay bare many uncomfortable truths about Indian healthcareFive young mothers in Kota died after childbirth, with suspicion falling on oxytocin injections. Investigations revealed the vials containe...
FDA issues compliance order for milk sector in Maharashtra; warns of Rs 10 lakh fine for violationsMaharashtra FDA has mandated strict food safety compliance across the entire milk supply chain, from farms to retailers. New guidelines aim...
New rules simplify drug launches, reduce manufacturer liability for overchargingNew rules now allow drug manufacturers to launch similar medicines without prior price approval, streamlining market entry. Companies can s...
Why CDSCO and BEE have not kept pace with the industries they overseeCDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade ...
Health ministry proposes faster approvals for medical device manufacturing licencesThe Union health ministry is proposing to significantly cut down the time taken to issue manufacturing licenses for medical devices. Aimed ...
Trade disruptions, API dependence, compliance costs: Pharma MSMEs spell out policy priorities on World MSME DayIndian pharmaceutical MSMEs are facing immense pressure from rising costs, supply chain woes, and stringent regulations. Industry represent...
Punjab drug body finds critical lapses at Jackson Laboratories' manufacturing facility in AmritsarThe Punjab FDA has taken decisive action by revoking the manufacturing licence of Jackson Laboratories in Amritsar due to severe regulatory...
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 ...
Indian pharma firms gear up to supply key cancer drug to USIndian drugmakers are stepping up to help the US combat a critical shortage of ifosfamide injection, a vital chemotherapy drug. Leading com...
NITI Aayog proposes pharma chapter for future FTAs, urges India to move up value chainNiti Aayog proposes a blueprint for free trade agreements to boost regulatory predictability in India's pharmaceutical sector. The think ta...
India's pharma supply chain remains 65 per cent dependent on China for critical inputs: NITI AayogIndia's pharmaceutical sector, despite being the "pharmacy of the world," faces significant reliance on China for raw materials, with nearl...
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
Why the ET Most Innovative AI Product Awards 2026 are spotlighting industry-specific innovationThe most impactful AI products of 2026 aren't built to do everything; they're built to solve one problem exceptionally well. The ET Most In...
Regulators tighten GMP oversight of pharma plantsSeveral states have constituted dedicated multi-member teams to ensure no facility slips through the cracks before a GMP Certificate is iss...
India attracted $843 billion in FDI between 2014-15 and 2025-26: OfficialIndia has seen a significant rise in Foreign Direct Investment, attracting USD 843 billion between 2014-15 and 2025-26. Key government init...
Govt outlines next phase of pharma growthThe government highlighted its achievements, reforms, and policy initiatives, aiming to boost exports from $31 billion to $50 billion by 20...
Uzbekistan can provide more incentives to Indian pharma firms, aims to become regional hub for supplyUzbekistan is inviting Indian drug companies to invest more. They are offering better subsidies and technology help. This aims to make Uzbe...
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...
Over 60% of pharma MSMEs yet to comply with updated manufacturing normsPharma industry officials say the revised Schedule M regulations could require Rs 10-15 crore per facility in upgrades, while talent shorta...
U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...