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DRUG MANUFACTURING NORMS
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...
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 ...
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...
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...
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...
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...
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...
Implementing corrective actions at Goa unit; stopped Digene production at the facility: AbbottThe drug regulatory body also advised doctors and healthcare professionals to carefully prescribe and educate their patients to discontinue...
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...
Granules India shares up 5%Shares of drug maker Granules India today rose by nearly 5 per cent after the US drug regulator FDA inspected its manufacturing facility.
Teva Pharmaceutical recalls 38,858 bottles of drugs made by Emcure Pharmaceuticals in US marketThe company is also recalling 7,694 bottles of anti- inflammatory drug indomethacin 25 mg, produced by Emcure Pharma, for non-adherence to ...
Sun Pharmaceutical Industries shares dive over 5% on USFDA import banShares of Sun Pharmaceutical Industries today fell by over 5 per cent after the US Food and Drug Administration banned import of drugs from...
Regulator mulls changes in labelling norms for drugsOfficials at the DCGI said the changes in the norms will ensure that consumers do not mistake the marketing firm to be the manufacturer of ...
Ranbaxy issue a wake up call for Indian pharma industry: Kiran Mazumdar-ShawThe $500 million fine on Ranbaxy, for violating drug manufacturing norms is "a wake up call" for Indian pharmaceutical industry.
- USFDA revoke's warning to Cadila Healthcare
The US drug regulator has revoked its earlier warning letter to Ahmedabad-based Cadila Healthcare Ltd.
- Ranbaxy begins Atorvastation exports to US
Ranbaxy Laboratories has commenced exports of Atorvastation Calcium tablets to the US market from its Mohali SEZ manufacturing facility.
- USFDA to inspect facilities of Zydus, Claris Lifesciences for violating American drug manufacturing norms
FDA had issued warning letter for Cadila's injectable unit at its plant in July for not meeting US drug manufacturing norms .
- Quality stamp for drugs in works
The ministry of health seeks to introduce a quality mark for the Rs 35,000-crore generic drugs market to enable consumers distinguish betwe...
- GMP norms for drug cos put off by 1 year
The government has deferred compulsory implementation of the new good manufacturing practices (GMP) norms for the drug industry by one year.