August 12, 2026
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- 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.
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