About GMP:
- Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.
- It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
- It covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
- The GMP system was first incorporated in India 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.
- There are around 10,500 manufacturing units in India out of which around 8,500 falls under Micro, Small and Medium Enterprises (MSME) category.
- The country has about 2,000 units in MSME category in the country having WHO-GMP certification.
What are the new regulations?
- Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months,
- Medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year
