Mumbai : In order to comply with the Union health ministry’s 6 to 12 months deadline for pharma industry to implement revised Schedule M, the Gujarat Food and Drug Control Administration (FDCA) recently organized a workshop on revised Schedule M in Himatnagar Municipality of Sabarkantha district in Gujarat. Around 75 Micro, Small and Medium Enterprises (MSMEs) participated in the workshop.
Gujarat today boasts of the highest number of over 1,081 WHO-GMP units and 140 US FDA approved drug manufacturing units in the country. There are around 10,500 manufacturing units in the country out of which around 8,500 fall under MSME category. India is a major exporter of medicines to low- and middle-income (LMIC) countries which require WHO-GMP certification. The country has about 2,000 units in the MSME category in the country having WHO-GMP certification.
“We will be conducting more such workshops in the coming days. There was a growing necessity to revisit and revise the principles and the concept of GMP mentioned in the Schedule M. Risk based inspections have given us sufficient evidence to plug the regulatory loopholes and adopt the revised guidelines in a protocol based manner. This is also very much required to keep pace with the fast-evolving global manufacturing and quality regulatory standards and to meet the demands of over 200 export destinations,” explained Gujarat FDCA Commissioner Dr H G Koshia.
As per the norms, WHO-GMP certification is valid for three years and violation will invite cancellation of licence and monetary penalty.
The Union health ministry had notified the deadline on August 2, 2023. It 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 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. It was revealed that some pharmaceutical firms have come under the scanner due to unethical practices like poor documentation, lack of process and analytical validations, absence of self-assessment and quality failure investigation among others.
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.
