The executive heads of drug companies will have to sign-off on a self-declaration form stating that their company complies with the Uniform Code for Pharmaceutical Marketing Practices (UCPMP-2024 ), for FY25.

This is the first time such a self-declaration is being sought under the updated UCPMP-2024, and it comes even as the pharma industry seeks clarity on aspects of its implementation, say industry-watchers. The executive heads of companies have to submit the self-declaration by June 30, a communication from the Department of Pharmaceuticals (DoP) said.

Earlier in March, the DoP had issued the updated ethical marketing code, UCPMP-2024, outlining a framework within which pharma companies could engage with doctors, without these interactions becoming an endorsement or inducement to push drug prescriptions.

Aligning with the guidance

“This reinforces what is already outlined in the UCPMP-2024 and companies will have to align with the guidance. If there is a transgression, it would be escalated to the ethics committee of the respective industry association and if unresolved, further to the apex committee headed by the Secretary, DoP. But there is no clarity currently on how penalties will eventually pan out for violation of self-declaration,” said Varsha Rajesh, Pharmaceutical and Life Sciences lawyer with Nishith Desai Associates.

Pharma industry representatives say companies are working to comply with the ethical code, that includes features like limiting brand-reminders to ₹1,000, and restricting Continuous Medical Education (CME) meetings to domestic venues.

Anil Matai, Director General with the Organisation of Pharmaceutical Producers of India (OPPI), a platform of largely foreign drugmakers, said companies were already primed since the code was issued earlier this year, and the self-declarations would go up on the association’s website. In the case of companies that do not belong to an association, or belong to multiple associations, they would have to send their declaration to the committee headed by the DoP secretary, he said.

While some industry-watchers remain critical on whether the ethical code will curb malpractices and the freebie culture, reportedly between drugmakers and doctors, others point out the latest communication is indeed the Centre’s nudge to get pharma companies to stick to the ethical code of promotion.