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). The committee has invited suggestions from the state drug regulatory authorities, industry and stakeholders for preparations of specific changes that could be incorporated under the D&C Rules.
In the 49th DCC meeting held on October 16, 2015 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 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 upgradation 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. The Schedule was last amended on December 11, 2001.
An official from CDSCO says, “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.”
GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials, premises and equipments to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
WHO has established detailed guidelines for GMP and many countries have formulated their own requirements for GMP based on WHO GMP.
DCC was requested to deliberate and make its recommendations. After deliberations, it was agreed that state drugs controllers will forward their suggestions to the DCG India in the light of their regulatory experience for taking into consideration.