DGHS Cracksdown On Unapproved Drug Manufacturing

All manufacturers are directed to cease the production of Meropenem and Disodium EDTA for injection immediately. Additionally, the product permissions granted for these drugs will be canceled without delay.

NPPA Fixes Ceiling Price of Several Formulations under Drugs (Prices Control) Order, 2013

The manufacturer shall issue a price list in Form–V from date of Notification to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. Every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

India Strengthens International Cooperation in Medical Product Regulation

The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.

CDSCO Launches Additional Forms on National Single Window System (NSWS Portal)

CDSCO has made the applications for grant of permission/ licence in Forms CT-10, CT-12, CT-13 live on the NSWS Portal from January 16, 2024. Form 12 will be live from January 24, 2024. All concerned stakeholders shall submit the above applications only through the NSWS Portal. The existing SUGAM online portal for these activities will be disabled from February 10, 2024.

New Drug Manufacturing Rules Introduced to Strengthen Quality Standards

The Amendment Rules introduce a new set of guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS” in Schedule M. The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.