Govt to extend GMP compliance deadline by one year for small drug firms
3 days, 15 hours ago

Govt to extend GMP compliance deadline by one year for small drug firms

Live Mint  

New Delhi: The Centre plans to extend the deadline for complying with good manufacturing practice, at par with the World Health Organization standards, for small pharmaceutical companies with a revenue of ₹250 crore or less less by one year till 31 December 2025. This comes in the backdrop of several respresentations sumbitted to the government by various associations requesting extension of the timeline to enable micro, small and medium pharma companies to comply with the provisions of the revised Schedule M. The government notified new Schedule M was in December 2023. Stakeholder comments awaited “We are looking forward to receving the comments from the industry stakeholders within 7 days following which Drugs Technical Advisory Board shall held a meeting as per the provisions, to amend the previous notification of December 2023,” said an official aware of the matter. Also read | Prices of TB, asthma, glaucoma, mental health drugs hiked by 50% Queries sent to the health ministry spokesperson remained unanswered till pess time.

Drug Msme One Year Schedule M Gmp Compliance  drugs  small  units  schedule  health  read  gmp  compliance  manufacturing  govt  m  drug  till  firms  extend  msme  deadline

History of this topic

Drug Makers To Face Stricter Audits, Surprise Inspections As ‘Schedule M’ Quality Rules Come Into Effect
5 months ago

Drug Makers To Face Stricter Audits, Surprise Inspections As ‘Schedule M’ Quality Rules Come Into Effect

News 18  

With ‘Schedule M’ coming into effect to improve the quality of India-made medicines, the drug regulator has now instructed officers across the country to begin audits of drug-making units to ensure they are meeting the new standards. Alongside this, the drug regulatory agency Central Drugs Standard Control Organisation has made Schedule M compliance mandatory for issuing new manufacturing licenses and …

Govt extends deadline for pharma co. bosses to submit unethical marketing practices undertaking till 31 July
5 months, 2 weeks ago

Govt extends deadline for pharma co. bosses to submit unethical marketing practices undertaking till 31 July

Live Mint  

New Delhi: The central government has extended the deadline for pharma and medical device company bosses to file their legal self-declarations assuring the government that they will not indulge in unethical marketing practices to promote their drugs. These companies can now file the self-declaration undertaking till 31 July 2024, wherein top executives from these firms must assure the government that …

Health Ministry notifies revised Pharma manufacturing rules under schedule M to ensure quality control
1 year ago

Health Ministry notifies revised Pharma manufacturing rules under schedule M to ensure quality control

The Hindu  

January 06, 2024 09:07 pm | Updated January 07, 2024 08:44 am IST - NEW DELHI Aimed at ensuring robust quality control for pharma and biopharmaceutical products, the Union Health Ministry on January 6 notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. Schedule M prescribes the Good Manufacturing Practices for pharmaceutical products and the revised …

Discover Related