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DRUG QUALITY NORMS
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...- Shelf-life norms for imported drugs may be relaxed to reduce wastageIndia is set to revise rules for imported medicines, proposing a 12-month minimum residual shelf life instead of the current 60% rule. This...
- Health ministry issues proposal for one-year residual shelf life for imported drugsThe Union Health Ministry is proposing to relax import rules for medicines, requiring a minimum 12-month shelf life upon arrival instead of...
- 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...
- Tooth regeneration therapy enters first human clinical trials in JapanA groundbreaking human trial in Japan is exploring a revolutionary treatment to regrow teeth. Researchers have identified a way to activate...
- The alchemist of Bengaluru: Kiran Mazumdar-Shaw began from a garageKiran Mazumdar-Shaw has named her niece Claire Mazumdar as successor, setting up a gradual leadership transition at Biocon. A pioneer who b...
- Mumbai watermelon case update: Stunning twist as no additives found in fruit by FDA, focus shifts to poison angleMumbai watermelon case: Investigations into the deaths of a Mumbai family have ruled out food adulteration, with FDA tests finding no conta...
- 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.
- Rs 70,00,000 worth fake Mounjaro injections seized in Gurgaon; Police expose illegal weight-loss drug racket in NCRGurgaon Drug Racket: Authorities in Gurgaon have busted a major illegal pharmaceutical racket involving spurious Mounjaro KwikPen (tirzepat...
- Regulator to digitally monitor supply chain of cough syrupsIn a groundbreaking effort to enhance public health safety, India's drug regulatory authority has unveiled a digital tracking system for co...
- Drug quality, ease of doing biz to top govt-pharma companies' talksThe health ministry is set to meet pharma industry representatives to discuss improving drug quality after several instances of exports fai...
- Drug firms told to set up system for 'prompt' recallsIndia enforced 'Schedule M' for drug manufacturers, emphasizing quality, recall systems. Companies must comply with strict rules on hygiene...
- India could see drug shortages, price rise owing to new rule: Industry executivesIndia's pharmaceutical industry may face drug shortages and increased prices as small and medium enterprises struggle to comply with new he...
- USFDA issues warning letter to Megafine Pharma for Vapi plantSummarising significant deviations from CGMP norms at the Vapi unit, the US Food and Drug Administration said that its investigators observ...
- India’s drug regulator asleep on the job?India must move in the direction of the US where drugmakers comply with stringent norms on quality and crackdown on unethical marketing pra...
- Quality stamp for drugs in worksThe ministry of health seeks to introduce a quality mark for the Rs 35,000-crore generic drugs market to enable consumers distinguish betwe...
- Govt plans separate quality norms for drugs and devicesThe government has decided to create separate quality guidelines for medical devices and not treat them as drugs.
- Centre to help drug cos meet stringent US quality lawsThe government has said that it will prepare the domestic drug industry to meet new regulatory challenges in the US market, which arose due...
- Domestic drug makers will not need GMP certificateDomestic drug makers will no longer need a certificate of good manufacturing practice (GMP) from WHO to sell their medicines within India.
- Drug cos face stricter checks on road to pricing freedomPharmaceutical companies will now have to face in-depth scientific scrutiny on how therapeutically useful are the ingredients that go into ...
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