Drug Regulators Move to Publicly List Firms Under Licence Suspension, Recall Orders
An expert committee under India's apex drug regulator has recommended that state drug authorities publish details of regulatory actions—such as licence suspensions and recall orders—on their official websites, and submit a monthly copy to the Central Drugs Standard Control Organisation (CDSCO). The move aims to eliminate regulatory gaps and improve transparency.
The recommendation comes after the Drug Consultative Committee observed that some manufacturers have been using photocopies of original product licences to secure procurement orders, even after their licences had been cancelled. Currently, states are not required to upload such regulatory actions online for public disclosure, leading to potential misuse.
If implemented, the new process would require states to post all regulatory actions—including suspension, cancellation, or recall—on their websites, making the information accessible to consumers, procurement agencies, and other stakeholders. The central regulator would receive a consolidated monthly report to ensure coordination and oversight.
The committee's minutes from a June 24 meeting note that the absence of public disclosure has created a 'regulatory disconnect'. By publicly naming firms facing action, the authorities aim to deter non-compliance and protect public health.
The recommendation is now under consideration by the CDSCO and state drug controllers. If adopted, it would mark a significant step toward greater accountability in India's pharmaceutical regulatory framework.
