Indian drug regulator joins global med device regulators' club
Drug regulator Central Drugs Standard Control Organisation (CDSCO) has joined the International Medical Device Regulators Forum (IMDRF) network as an affiliate member.
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53 drugs including paracetamol fail quality test by regulator
Vitamin tablets Shelcal, antiacid Pan-D, paracetamol IP 500 mg, Type-2 diabetic drug Glimepiride, hypertension drug Telmisartan and antibiotics Cepodem as well as Clavam were of non-standard quality.
National Pharma Policy to harmonise drug standards with global norms, simplify licensing
The ministry wants the policy to simplify the licensing system to avoid duplication of efforts and ensure better coordination among different regulatory authorities
Lupin shares dip 4% on US FDA observations for Pithampur unit
The U.S. drug regulator has issued Form 483 with ten observations for Lupin’s Pithampur unit-2 manufacturing facility.
Now no customs duty on import of 'rare disease' medicines for personal use
A list out 51 medical problems including several metabolic disorders has been brought under the duty exempted category for import for personal use.
USFDA inspections to be less disruptive for Indian pharma sector: Report
Indian pharma companies have increasingly de-risked their operations by slowly and steadily increasing sales to non-US markets, says India Ratings and Research.
Lupin launches asthma drug DIFIZMA; stock gains
The pharma major has launched a novel fixed-dose triple drug combination ‘DIFIZMA’ to treat inadequately controlled asthma.
Sun Pharma gets U.S. FDA warning for Halol facility; share falls 2%
The pharma company received a warning letter from the U.S. FDA for violations of manufacturing standards at the Halol facility in Gujarat.
Lupin shares rise 4% on nod for Mirabegron tablets
Lupin has received U.S. FDA approval for Mirabegron Extended-Release Tablets used for the treatment of overactive bladder.
Customs seize 5.85 kg cocaine in biggest-ever haul at Delhi airport
The seizure is the biggest haul at any airport in India.
