Health Ministry sets deadline for pharma industry to implement revised Schedule M

Health Ministry has given six months for small manufacturers and 12 months to large units, to get their WHO-GMP certification


To bring in better quality management that will help Indian pharmaceutical manufacturers grow their business nationally and internationally, the Health Ministry has given six months for small manufacturers and 12 months to large units, to get their World Health Organisation-Good Manufacturing Practices (WHO-GMP) certification.

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 done 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, etc.

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“Observation from ongoing risk-based inspections indicated the need to take a re-look at the current GMP regulations and Quality Management Systems being followed by pharmaceutical manufacturers. We have inspected 162 units and 14 public testing labs till now. Major issues found during inspections included – poor documentation, lack of process and analytical validations, absence of self-assessment, absence of quality failure investigation, absence of internal product quality review, absence of testing of incoming raw material, infrastructural deficiency to avoid cross-contamination, absence of professionally qualified employees, faulty design of manufacturing and testing areas etc,’‘ said a senior Health Ministry official.

He added that based on these findings and to keep pace amid the fast-changing manufacturing and quality domain, there was a necessity to revisit and revise the principles and concept of GMP mentioned in Schedule M.

“A draft notification was issued in 2018 to upgrade and synchronise Schedule M comparable to international standards. Now, considering the importance of upgraded and revised GMP in ensuring quality of drugs, the Government has decided to finalise the draft rules. The time that is provided to the industry, then, is for their smooth transition from the present Schedule M to revised Schedule M,’‘ he added.

While WHO-GMP certification is valid for three years, violation will invite cancellation of licence and monetary penalty, the Ministry added.

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, specific requirements for manufacturing of hazardous products, etc.

There are around 10,500 manufacturing units in the country out of which around 8,500 fall under Micro, Small and Medium Enterprises (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 MSME category in the country having WHO-GMP certification.


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