Govt to plug regulatory gaps in drug deals

Synopsis

Authorities discovered drugmakers hid licence cancellations to obtain supply orders. The government now mandates states display this information on their websites. This data will be shared monthly with the Central Drugs Standard Control Organisation. The move aims to ensure quality medicines reach hospitals and consumers. Timely disclosure strengthens monitoring between the Centre and states.

Authorities have found that some drugmakers suppressed information about the cancellation of their manufacturing licences to secure supply orders from the government and other healthcare agencies, according to people in the know.

To plug this gap, the government has directed all states to display information on licence cancellations and suspensions on their websites and share the data with the Central Drugs Standard Control Organisation (CDSCO) every month, they said.

The move is aimed at ensuring that quality medicines reach hospitals and consumers.

At a recent meeting of the Drug Consultative Committee (DCC), the experts were informed that some manufacturers have been found using a photocopy of the original product licence for procurement orders despite the cancellation of their original permit.

It was also seen that details related to the cancellation or suspension of licences were not being displayed by states/Union Territories on their official website for disclosure, leaving the public with no way to verify a manufacturer's regulatory status.

It was also observed that data was not shared with the CDSCO, leading to a regulatory disconnect between the Centre and the states.

"Timely disclosure of licence cancellations and suspensions is critical to prevent misuse and to strengthen the monitoring mechanism between the Centre and states," an official told ET.

After deliberation, the DCC said the details of cancellation/suspension of licence, stop order, recall alert, etc. should be posted on the state licensing authority's website and also shared with the CDSCO before the 10th of each month.

"All states shall furnish monthly NSQ data in the prescribed format within the stipulated timeline," said the minutes of the meeting. ET has seen the document.