WHO: Good Manufacturing Practices
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.
- 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