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Good Manufacturing Practice (GMP) and Schedule



  Sep 19, 2023

Good Manufacturing Practice (GMP) and Schedule M of the Drugs and Cosmetics Rules, 1945



The Union Health Ministry is considering amendments to make Good Manufacturing Practice (GMP) mandatory for all pharmaceutical firms in India.
This move comes after a series of scandals involving Indian-made drugs linked to children's deaths abroad.
Here's a breakdown of the situation:
 
Current Status: GMP was recently made mandatory for micro, small, and medium enterprises (MSMEs) manufacturing drugs in India.
 
Global Importance: India is the largest supplier of medicines to low-middle-income countries (LMIC), and the World Health Organization's (WHO) GMP certification is required for supplying medicines to LMICs.
However, only 2,000 out of 10,500 manufacturing units in India have this certification.
 
What is GMP: GMP, as mandated by the WHO, sets essential standards to enhance product quality by controlling various factors like materials,methods, machinery, processes, personnel, facilities, and the environment.
 
Government Action: The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has held meetings with industry stakeholders and drug firms.
Workshops have also been conducted with state drug controllers to sensitize them about the enforcement of the new GMP regime.
 
Amendment Details: Proposed amendments to Schedule M of the Drugs and Cosmetics Rules, 1945, will require large companies (with a turnover exceeding Rs.250 crore) to comply with GMP within six months and MSMEs within 12 months.
 
Regional Workshops: One-day regional workshops have been organized across India for disseminating information about the revised Schedule M requirements to stakeholders.
 
Industry Response: Industry associations like the Indian Drugs Manufacturing Association (IDMA) have disseminated information to member companies and are participating in discussions with the DCGI.
 
In summary, India is taking steps to make GMP mandatory for pharmaceutical firms to enhance the quality and safety of medicines produced in the country, especially those intended for export to LMICs.


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