Explanation
Good Manufacturing Practices : Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
- After a number of overseas deaths allegedly linked to India-made drugs, the Union Health Ministry has notified its Good Manufacturing Practices (GMP) that aim to ensure the quality of drugs made in the country, directing pharmaceutical companies to implement them within 2024.
- The new GMP focuses on quality control measures, allows mechanisms for digitally maintaining records that cannot be tampered with and puts in place a system to recall drugs if necessary.
- The notification comes months after the Union Health Minister urged pharmaceutical companies to begin implementing these standards, which are on a par with those set by the World Health Organisation (WHO).
- Large companies, which have a turnover of more than Rs 250 crore, will now have to implement the guidelines within the next six months. Small and medium manufacturers, which have a turnover of less than Rs 250 crore, will get a year.
- There are nearly 10,500 drug manufacturing units in the country. Of them, 2,000 large companies that export medicines are already WHO-GMP compliant.