India has been described as the ‘pharmacy of the world’. Though quality is of paramount importance in all the industries, it is a must in pharma industry as here we are dealing with life. The department of pharmaceuticals (DoP) has taken several steps to upgrade the manufacturing practices. The approach paper on National Pharmaceutical Policy, 2023 intends to promote Indian pharma exports. India manufactures 60,000 plus generic brands. It accounts for 20 per cent of the global supply of generics. India’s pharma exports are $27.9 billion in 2024.

The pharma manufacturing hubs in India are Gujrat, Maharashtra, HP and Telangana.

Recently, the apex drug regulatory body (Central Drugs Standards Control Organization: DSCO) withdrew the power of state licensing authorities (SLAs} to issue clearances to export-only drug manufacturing units. SLAs used to issue NOCs.

Banned drugs are those that are banned for sale in India but allowed in importing country. Unapproved drugs are those that are not yet approved in India but are approved elsewhere.

SLAs are inadequate to monitor manufacturing standards — there are ill-equipped testing labs, paucity of drug inspectors, poor understandings of specific rules, patchy surveillance and lack of legal experience to take action against violators.

Schedule M guidelines are integrated to WHO-GMP (good manufacturing practices) standards. Last year about 2000 out of 10,500 manufacturing units were compliant with WHO-GMP standards.

India is a key player in generics market. With about $250-billion worth of new drugs are going off patent in the coming decade India must, therefore, strengthen its manufacturing practices to avail of this opportunity.