A welcome move on drug regulation

The Union government is likely to make good manufacturing practices mandatory for all manufacturing drug units in the country

In a possible response to a complaints about poor quality drugs coming out of India, the Union government is likely to make good manufacturing practices (GMP) mandatory for all manufacturing drug units in the country, this newspaper reported last week. The process comes as India’s drugs regulator is seeking to crack down on adulterated or substandard drugs.

GMP requires proof that correct procedures are followed at each step in the manufacturing process. (Hemant Mishra/Mint)

This is a welcome move. India’s pharmaceutical industry has taken on a bigger global profile, catalysing the export of drugs, medical equipment and vaccines around the world, cementing India’s place as a pharmacy to the world. Yet, reports of deaths and illnesses from the Gambia, Uzbekistan and the United States linked to medicines imported from India dented this reputation. The GMP system – which covers all aspects of production – will be useful in establishing more robust oversight and bolstering existing regulation. And the government’s push for it indicates that despite its public avowals about complaints against Indian pharma imports being a “conspiracy”, it remains concerned about the abilities and diligence of some manufacturers.

The key will lie in implementation. GMP requires proof that correct procedures are followed at each step in the manufacturing process. Given the tangle of regulatory bodies and poor monitoring processes, ensuring this will be critical. The country currently has 38 drug regulators, and their respective network of laboratories, inspectors, and jurisdiction. Access and transparency also remain barriers since many laboratories don’t make their results available. Implementation of GMP, if it happens, will require strong political will and administrative dexterity.