GS Paper II

News Excerpt:

Indian authorities, over a one-year-period, have cancelled licences of 64 pharma companies, while 17 drug testing laboratories have been shut down for non-compliance with ‘good manufacturing practices’.

What are ‘Good Manufacturing Practices (GMP)’?

• As per the World Health Organisation (WHO), GMPs refer to that aspect of quality assurance that ensures medicinal products are consistently produced and controlled as per the quality standards appropriate to their intended use and as required by the product specification. 
• GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented.
• It also ensures that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. 
• Apart from production and quality control matters, there is also a legal component that covers responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints.

Crack Down and Current Status of Pharma manufacturing industry:

• According to the Union Ministry of Health and Family Welfare checks and investigations were carried out during the last 12 months, where 423 companies, including listed entities and drug testing laboratories came under the scanner. 
• Post the investigation, operations were stopped at 101 pharma companies and there were 52 instances of suspension of licences. Another 281 companies were issued show-cause notices.
• There were 131 drug testing laboratories, against which action was taken. Suspension of testing activities was ordered against 52 of them.
• None of the licences that were cancelled has been renewed or re-issued so far.
• There are around 10,500 manufacturing units in the country, of which 8,500 fall under the MSME category. 
• Around 2,000 MSMEs, mainly exporters, have a WHO GMP (good manufacturing practice) certification. 
• India is the world’s third-largest maker of drugs by volume after the US and China. Pharma exports are set to rise to over $20 billion in FY24, and cough syrup exports stand at $15 million a year.

Reasons behind crackdown on Pharma industry:

• The crackdown on pharma companies was carried out after reports of spurious drugs being sold abroad (exports) from India surfaced. 
• Questions were also raised on the quality of cough syrups being exported after child deaths were reported in some countries.
• In a May order, the Commerce Ministry had made it mandatory for cough syrup manufacturers to get their stocks tested at a government lab before shipping.
• Till December, some 50-odd cough syrup makers had failed to meet quality standards.

Conclusion:

Adherence to Good Manufacturing Practices (GMP) is crucial for the pharmaceutical industry to ensure the production of safe and high-quality medicines. The recent crackdown on non-compliant companies highlights the importance of stringent regulations to maintain India's reputation as a reliable supplier in the global pharmaceutical market.