Drug Regulator Weighs Public Digital Platform for Batch-Level Quality Test Reports

India's drug regulator is examining a proposal to create a digital platform that would publish batch-level quality-test reports of medicines cleared for sale, a step that would give consumers direct visibility into the drugs they use.

The plan was taken up in the second week of September at a meeting chaired by the Drugs Controller General of India, following a representation from Rajasthan's drug control administration. The proposal was prompted by the Kota hospital incident in May, in which five women died after being given spurious oxytocin injections. Officials said the matter has since been recommended for further discussions.

At present, the Central Drugs Standard Control Organisation flags quality failures only through monthly not-of-standard-quality alerts. Under existing law, a manufacturer may release a product for sale after testing it in-house or through a regulator-approved laboratory, but is not required to pass the test report down the supply chain. The government communication notes there is no provision obliging a manufacturer to forward product test reports to carrying and forwarding agents or state druggists.

The Rajasthan proposal calls for a suitable provision in the Drugs and Cosmetics Act, 1940, and its 1945 Rules to create a digital platform where manufacturers' quality-testing reports would be placed in the public domain. The state drug controller argued that giving the public information about drug quality is essential and that pre-marketing test reports prepared by manufacturers should be disclosed.

The move would extend a broader transparency push by the apex regulator, which also plans to make inspection findings from pharmaceutical factories public. India is home to more than 3,000 drug companies and 10,500 manufacturing units that supply both domestic and global markets, in an industry valued at about $60 billion.

Industry experts, however, questioned the practicality of universal disclosure. Uday Bhaskar, former director general of Pharmexcil, said that with manufacturers producing crores of batches and over eight lakh retail chemists nationwide, making every record available to all consumers would add little value. He suggested authorities instead focus on not-of-standard-quality products, communicating such information immediately to every retailer, wholesaler and consumer, backed by an effective recall mechanism, prioritising actionable safety over digital platforms.

Queries sent to the health and family welfare ministry, the DCGI office and the Rajasthan drugs controller had not been answered at the time of going to press.