CDSCO prohibits manufacture, sale and distribution of unapproved Fixed Dose Combinations (FDC) Drugs
The Central Drugs Standard Control Organisation (“CDSCO”) has issued a Circular highlighting concerns regarding certain Fixed Dose Combination (“FDC”) drugs that were […]
MoHFW notifies Drugs and Cosmetics (Compounding of Offences) Rules, 2025, provides for grant of immunity from prosecution through compounding of offences
The Ministry of Health and Family Welfare has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (hereinafter “the Rules”), effective […]
CDSCO introduces new online system for submission of application for seeking extension of timeline for adhering with the updated regulations under revised Schedule M through ONDLS Portal
Further to what we reported earlier (please refer to the e-mail in trail), the CDSCO has developed a new system for online […]
Health Ministry prohibits the import, manufacture and sale of Chloramphenicol and Nitrofurans in drug formulations for use in food-producing animal rearing systems
The Health Ministry has issued an immediate prohibition on the import, manufacture, sale and distribution of all drug formulations containing Chloramphenicol or […]
Public comments invited on draft Drugs (Amendment) Rules till 21st March 2025; proposes QR Code labelling and risk-based drug inspections
The Ministry of Ayush has published the draft Drugs (Amendment) Rules, 2025 (“Draft Amendment”), proposing amendments to the Drugs Rules, 1945 for […]
Health Ministry extends Schedule M compliance deadline for small and medium manufacturers with turnover below Rs. 250 crores to 31st December 2025
The Ministry of Health has issued an amendment to Schedule M, granting small and medium scale manufacturers the opportunity to extend their […]
Public comments invited on draft standardized IVD performance evaluation protocol by ICMR and CDSCO till 15th March, 2025
The Indian Council of Medical Research (“IMCR”) and the Central Drugs Standard Control Organization (“CDSCO”) have collaborated to develop standard evaluation protocols […]
Draft Pollution Guidelines to Pave the Way for Greener Pharmaceutical Industry in India
Despite having a significant pollution potential, the pharmaceutical industry in India lacks specific guidelines for pollution management. The National Green Tribunal (Chennai) […]
CPCB invites comments on Draft guidelines for the Pharmaceutical Industry in India’ till 5th February 2025
The Central Pollution Control Board (CPCB) has invited comments on ‘Draft guidelines for the Pharmaceutical Industry in India’ till 5th February 2025. […]
MoHFW proposes extended deadline for compliance with revised Schedule M for small and medium scale manufacturers: public comments invited on draft Notification
In view of several representations to extend the timeline to enable small and medium scale manufacturers to comply with the provisions of […]
Reduced Custom Duty to nil and GST to 5% on three anti-cancer medicines, effective October 10, 2024, requiring price revisions by manufacturers
The National Pharmaceutical Pricing Authority (“NPPA”) has issued a Notification informing that the Department of Revenue, Government of India, has announced a […]
Pharmaceuticals Department notifies revisions to sub-scheme ‘Revamped Pharmaceutical Technology Upgradation Assistance Scheme’: Increases incentive cap and simplifies application process for Pharma MSMEs
Department of Pharmaceuticals has notified modifications under the sub-scheme “Revamped Pharmaceutical Technology Upgradation Assistance Scheme”. This is pursuant to the deliberations held […]