WHO: Good Manufacturing Practices

August 3, 2023

GS Paper II Indian Polity and Governance

Context:

Recently, the Government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP), to bring them on par with World Health Organisation (WHO) standards.

More about the news:

These revised practices align with the World Health Organisation (WHO) standards.
- WHO-GMP certification is valid for three years
Objective: To bring in better quality management that will help Indian pharmaceutical manufacturers grow their business nationally and internationally.
- Currently, only 2,000 of the 10,500 manufacturing units in the country were found to be compliant with the global WHO-GMP standards.
Requirement: Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
- Those who do not comply with the direction will face suspension of licence and/ or penalty.

Good Manufacturing Practice:

GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act.
They are also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice
These regulations require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
In India, GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amended in 2018