The Union Health Ministry is actively considering amendments to make Good Manufacturing Practice (GMP) mandatory for all pharmaceutical firms in India. This initiative is in response to a troubling series of scandals involving Indian-made drugs that have been linked to children’s deaths abroad. Below is an overview of the current situation:
Recently, GMP was made mandatory specifically for micro, small, and medium enterprises (MSMEs) engaged in drug manufacturing within India.
India stands as the largest supplier of medicines to low-middle-income countries (LMIC). To facilitate the supply of medicines to these nations, obtaining WHO certification for GMP is crucial. However, it is concerning that only 2,000 out of 10,500 manufacturing units in India currently hold this certification.
As defined by the WHO, GMP establishes vital standards aimed at enhancing product quality by regulating various elements such as materials, methods, machinery, processes, personnel, facilities, and the overall environment.
The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has been proactive in holding meetings with industry stakeholders and drug firms. Additionally, workshops have been conducted with state drug controllers to educate them on the enforcement of the new GMP regulations.
The proposed amendments to Schedule M of the Drugs and Cosmetics Rules, 1945, will mandate that large companies (with a turnover exceeding Rs. 250 crore) adhere to GMP within a six-month timeframe, while MSMEs will have a period of 12 months to comply.
To disseminate information regarding the revised Schedule M requirements, one-day regional workshops have been organized across India for various stakeholders involved in the pharmaceutical sector.
Industry associations, such as the Indian Drugs Manufacturing Association (IDMA), are actively sharing information with their member companies and engaging in discussions with the DCGI to align with the new compliance measures.
In conclusion, India is making significant strides towards mandating GMP for pharmaceutical firms. This move is crucial for enhancing the quality and safety of medicines produced in the country, particularly those intended for export to LMICs.
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