Good Manufacturing Practices

August 4, 2023

Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.
- GMP are mandatory standards which build and bring quality into product by way of control on materials, methods, machines, processes, personnel and facility or environment etc.
- GMP were first incorporated in Schedule M in 1988. The norms were last amended in 2018.
Schedule M of the Drugs and Cosmetics Act, 1940, deals with GMP for pharmaceutical manufacturing units, including specific requirements pertaining to premises, plant and equipment.
Timeline (for completion of GMP norms begins August 1 2023)-
- Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months,

About only 2,000 of the 10,500 manufacturing units in the country were found to be compliant with the global WHO-GMP standards.

Medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
Companies that do not comply with the direction will face suspension of licence and/ or penalty.

This will lead to at least 11 specific changes in the manufacturing process on the ground, including introduction of a pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.