Mumbai : To create awareness amongst drug manufacturers about good manufacturing practices (GMP) requirements to ensure quality of medicines, workshops on Revised Schedule M requirements will be held in Mumbai and Ahmedabad on September 30 by the Central Drugs Standard Control Organisation (CDSCO).

On August 2, 2023, the Union health ministry had given six months’ time for small manufacturers and 12 months’ time to large units, to get their World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification. A draft notification was also earlier issued in 2018 to upgrade and synchronise Schedule M comparable to international standards.
Observation from ongoing risk-based inspections necessitated the Government to take a re-look at the current GMP regulations and Quality Management Systems (QMS) being followed by pharmaceutical manufacturers.

GMP comprises mandatory standards that build and bring quality to products by way of control on materials, methods, machines, processes, personnel, and facility or environment, etc. The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was made in June 2005. WHO-GMP standards are now part of the revised Schedule M.

Schedule M prescribes requirements of facilities and their maintenance, personnel, manufacture, control and safety testing, storage and transport of material, written procedures and records, traceability among others. Some of the major changes which will happen with introduction of the revised Schedule M are introduction of pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, change control management, self-inspection, quality audit team, suppliers audit and approval, stability studies as per recommended climate condition, validation of GMP-related computerised system and specific requirements for manufacturing of hazardous products among others.

The CDSCO conducted a one day workshop on Revised Schedule M and Drugs and Cosmetics (D&C) Act in hybrid mode at Hyderabad on September 16, 2023. Dr S Eswara Reddy, joint drug controller, CDSCO was the keynote speaker and the program was coordinated by Dr A Ramkishan, deputy drugs controller (India), CDSCO Hyderabad Zonal Office. It was jointly organised by CDSCO and the Indian Drug Manufacturers’ Association (IDMA) Telangana chapter. A hybrid workshop was conducted as per the directions of the Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi to make awareness among stakeholders regarding revised schedule M and D&C act, which is going to be implemented once notified in the official Gazette.

Dr Reddy gave a presentation related to additional changes that were incorporated in the upcoming Schedule M.

The program at Hyderabad was conducted in coordination with IDMA, Telangana. Kamalasan Reddy, director general, Drugs Control Administration (DCA), Telangana was the chief guest. Drug controller officials from Andhra Pradesh, Telangana, Hyderabad and Vizag attended the event with over 400 delegates physically present and around 8 000 attendees participated through online mode from pharma industry management and technical domain. The program started with the welcome address by J Rajamouli, chairman, IDMA, Telangana chapter, RK Agarwal, national president, Bulk Drug Manufacturers Association (India) (BDMA), G Koteshwar Rao, national president, Drugs Control Officers (I) Welfare Association (DCOWA), Dr PV Appaji, ex director general (DG), Pharmaceuticals Export Promotion Council of India (Pharmexcil) and Hanumantha Rao, ex director, Drug Control Administration (DCA), Andhra Pradesh (AP) graced the occasion.

The Pharmexcil DG Uday Bhaskar has also informed and urged the member companies to attend the workshops on “Revised Schedule M Requirements” to create awareness on GMP requirements and upgraded Schedule M-2018.