With the relationship between pharmaceutical companies and healthcare professionals coming in for intense scrutiny, the Centre has set up a high-level committee to examine the need for a legally enforceable mechanism to regulate pharmaceutical marketing practices.

The five member committee chaired by NITI Aayog member (Health and Nutrition), VK Paul, also includes S Aparna, Secretary- Department of Pharmaceuticals (DoP), Rajesh Bhushan, Secretary, Health and Family Welfare, Chairman — Central Board of Direct Taxes and Joint Secretary (Policy), DoP. They are to submit their recommendation in 90 days, an official note said.

Ongoing case

The development comes against the backdrop of an ongoing case in the Supreme Court, scheduled for later this month. Petitioners, the Federation of Medical and Sales Representatives Associations of India (FMRAI) have called for greater regulation of the pharmaceutical industry’s promotional practices to the medical fraternity.

In fact, an earlier hearing of the case had put the spotlight on paracetamol brand Dolo and its rise in popularity during Covid-19-times. This discussion arose, after a Government note alleged unethical practices and freebies to the tune of ₹1,000 crore, by the drugmaker — something the company, Micro Labs has denied. The incident involving the company is however not part of the SC case.

Separately, the Indian Pharmaceutical Alliance (a platform of large domestic drugmakers) had on the direction of the National Pharmaceutical Pricing Authority, looked into the issue and cleared Micro Labs of misdoings in promoting Dolo-650. Investigating alleged tax violations, it added, was beyond its capacity.

Statutory framework

An FMRAI representative told businessline, a clear statutory framework was necessary to define penalties for transgressions by drug companies. The DoP’s Uniform Code of Pharmaceutical Marketing Practices (UCPMP) had been brought in from January 1, 2015.But the code is voluntary and health experts have long called to make it mandatory/ statutory.Nevertheless, the ethical code provides for filing complaints, inquiry by Apex Committees of Associations, penal actions, etc. to be taken by the pharmaceutical association of which the company is a member.

There is also the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, under the Indian Medical Council Act, 1956, that prohibits physicians/medical practitioners from committing unethical acts. It also outlines enforcement in case of complaints and these are enforced by the National Medical Commission, involving State Medical Councils. In fact, pharmaceutical marketing practices are also governed by a CBDT circular (no. 5/2012 dated 1.8.2012), the Government note said.