Schedule M to be mandatory for MSME pharma firms soon

Subject :Schemes

Concept :

India’s small drugmakers in the micro, small, and medium enterprises (MSME) sector will soon be required to adhere to the good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Act.
Health Minister Mansukh Mandaviya announced this decision after engaging with industry representatives, emphasizing the need for quality assurance and reducing compliance burdens.
The move aims to uphold India’s reputation as the world’s pharmacy by ensuring the highest standards in drug manufacturing.

Phase-wise Implementation of Schedule M:

The adherence to Schedule M practices will be implemented gradually in MSME pharma firms.
Schedule M guides on Good Manufacturing Practices regarding company premises, quality control system, quality check laboratories, production, cleaning of equipment, housekeeping, cross-contamination, and other related topics.
Schedule M-I: Deals with the requirements of factory premises for manufacturing of Homeopathic preparations.
Schedule M-II: Deals with the requirements of premises, plant, and equipment for manufacture of cosmetics.
Schedule M-III: Deals with the requirements of premises, plant, and equipment for manufacture of Medical devices.

Applicability

These practices are applicable to all manufacturers of drugs and cosmetics who have their manufacturing facility with a good manufacturing practice facility registration.
The manufacturing facility should aim to ensure that all personnel concerned with the manufacture know the information necessary to decide whether or not to release a batch of drugs for sale and to create an audit trail for future reference which shall permit investigation of the history of any suspected defective batch.