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PHARMACEUTICAL REGULATIONS INDIA
Sun will require HC nod for Semaglutide tablet launchThe Delhi High Court has directed Sun Pharma Laboratories to seek its approval before launching semaglutide tablets, following Novo Nordisk...- Regulator mandates full review of globally unapproved drugsIndia’s drug regulator has clarified that new drugs not approved anywhere globally must undergo the full domestic regulatory process, even ...
- Bombay HC warns Maharashtra FDA for ‘sword to kill mosquito’ approach as Cadila challenges drug banThe Bombay High Court criticized the Maharashtra FDA for its drastic actions against companies. The court directed the regulator to grant h...
- Medical devices are not pharma products, companies say while opposing Draft BillIndia’s medical device industry and healthcare groups have opposed the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that ...
- Independence Day 2026: India, which once couldn't make smallpox vaccine, has now crossed a pharma milestone the world can't ignore2026 Independence Day: India's pharmaceutical industry marks a historic milestone with a new drug approval. This achievement reflects decad...
- Picking the right pharma stock is getting harder; so pick a portfolio: 20 stocks with -23% to +22% downside to upside potentialFor Indian pharma, the regulatory risk is still real. A US FDA inspection can still cause trouble. A plant making an important product or g...
- Forget Nvidia chips, China's next big race is being slowed down by an unlikely rival: monkeysLab primate prices in China have surged over 1,000% in eight years, with a single cynomolgus macaque now costing around Rs 22 lakh. The sho...
- Govt plans new drugs law to overhaul pharma, medical device regulationThe government is set to replace the 1940 Drugs and Cosmetics Act with a new law covering drugs, medical devices and cosmetics. The draft b...
- Centre to bar drugmakers from selling mislabelled, fraudulently approved products under new provisionsNew rules will bar drugmakers from selling products if false information was provided. The Union Ministry of Health & Family Welfare has am...
- These mid-cap stocks with ‘Strong Buy’ & ‘Buy’ recos can rally over 25%, according to analystsA word of caution for all those who have exposure to mid cap stocks or are planning to increase it. Just keep one thing in mind: If there i...
- India Inc goes on a global shopping spree with a new wishlistIndian companies are increasingly pursuing strategic overseas acquisitions. They now focus on acquiring capabilities and technology rather ...
- IPA seeks to regularise 'legacy' drugsThe Indian Pharmaceutical Alliance seeks to regularize many drugs. These drugs have been marketed for years without central approval. Examp...
- Saudi Aramco supplier HD Fire plans to launch IPO in OctoberFire protection systems manufacturer HD Fire Protect is planning to launch its IPO in October through an offer for sale of 2.6 crore shares...
- FSSAI suspends Kolkata bakery major Switz Foods' licence over unhygienic manufacturing, pest infestationIndia's food regulator has suspended Switz Foods' manufacturing licence. Serious non-compliances were found during a recent unit inspection...
- India takes action against 90% of inspected high-risk pharmaceutical facilities, regulator saysAmid increasing global concerns over Indian pharmaceuticals, India's drug regulator is rigorously addressing high-risk manufacturing sites....
- FSSAI suspends licence of Dior Pharmaceuticals for violations at nutraceutical plantThe FSSAI has suspended Dior Pharmaceuticals' license due to serious violations. The nutraceutical factory operated with severely deficient...
- BDR Pharmaceuticals eyes controlling stake in Acme FormulationPAG acquired a controlling stake in Acme Formulation for $145 million (?1,054 crore) through its PAG Asia III buyout fund in 2021. Founder ...
- US FDA approves world's first oral cholesterol-lowering pill: What it means for patientsThe FDA has approved Lipfendra, an oral PCSK9 inhibitor, for high cholesterol. This new once-daily pill offers an alternative to injectable...
- Pharma deal activity hits four-quarter low, but mega Sun Pharma acquisition drives valueIndia's pharma and healthcare sector recorded 65 deals worth $13.9 billion in Q2 CY2026, with volumes falling 17% quarter-on-quarter to a f...
- Trump's Generic Drug Tariffs Explained: What it means for Indian pharma before the 200% stormTrump's generic drug tariffs plan provides Indian drugmakers a two-year duty-free window. This allows companies time to reassess manufactur...
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