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The Drug Consultative Committee (DCC) has proposed the amendment of Schedule M of Drugs & Cosmetics Rules (D&C Rules), 1945 to harmonize the provision with WHO Good Manufacturing Practices (GMP). And for these amendments the committee is inviting suggestions from the state drug regulatory authorities, industry and different stakeholders for preparations of specific changes that could be incorporated under the D&C Rules. The Schedule was last amended on December 11, 2001.
It was proposed to revisit the good manufacturing practices prescribed under Schedule ‘M’ in view of WHO guidelines. Dr G N Singh, Drug Controller General of India briefed the members in the 49th DCC meeting held on October 16, 2015, that the meeting has specifically been convened to discuss issues relating to strengthening of drug regulatory system in the country and the steps required for uplifting of the GMP to WHO level.
The Schedule M of D&C Rules, 1945 provides details of good manufacturing practice, requirements of premises, plant and equipment for manufacturing of pharmaceutical products.GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to lessen the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. WHO has established detailed guidelines for GMP and many countries have formulated their own requirements for GMP based on WHO GMP.
“The Schedule M will be revised. We have done the gap analysis of the provisions of good manufacturing practices and the WHO GMP. It has been 15 years since the last amendment, the amendment is important to update GMP. Further we will also discuss it with the stakeholders.” said an official member from CDSCO.
The Drug Consultative Committee (DCC) was requested to deliberate and make its recommendations. Deliberations will follow by the suggestions of state drugs controllers to the DCG India in the light of their regulatory experience.
