Centre forms 3-member panel to review pharma marketing code, enforcement

The three-member committee will assess the effectiveness of the UCPMP, examine enforcement mechanisms and recommend measures to curb unethical pharmaceutical marketing practices

The Centre is reviewing the existing framework governing pharmaceutical marketing practices after representative bodies of medical representatives and other executives raised concerns over the self-regulatory framework proposed by the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024. To address these concerns, the Department of Pharmaceuticals (DoP) has constituted a three-member committee to examine the effectiveness of the norms introduced in 2024.

 

The committee will be headed by Niti Aayog Member and former AIIMS Delhi Director M Srinivas. Former Union Health Secretary Preeti Sudan and Medanta Hospitals Chairman Naresh Trehan have also been named to the panel, according to documents seen by Business Standard.

 

The committee’s terms of reference include examining the effectiveness of oversight and enforcement mechanisms to address unethical pharmaceutical marketing practices and identifying measures to improve transparency, accountability and compliance.

 

“The committee shall furnish its recommendations to the Department of Pharmaceuticals within a period of two months from the date of its first meeting, after undertaking the requisite consultative process and duly considering the material and suggestions placed before it,” the DoP order dated October 22 stated.

 

The panel will receive secretarial assistance from the DoP. It may consult stakeholders, technical and professional experts, and relevant institutions or bodies as necessary.

 

The move follows concerns raised by pharmaceutical executives and medical and sales representatives’ associations over the voluntary, industry-led self-regulatory framework under the UCPMP notified in 2024.

 

Under the 2024 norms, pharmaceutical associations were required to constitute a five-member Ethics Committee for Pharma Marketing Practices (ECPMP) and set up a dedicated portal on their websites.

 

Appeals against decisions of the ECPMP could be taken to the Apex Committee for Pharma Marketing Practices (ACPMP), headed by the Secretary, DoP, with a joint secretary and a finance officer as members.

 

However, the Federation of Medical and Sales Representatives’ Associations of India (FMRAI) had then said that while the code provided for complaints made by an individual to be escalated from an industry-centric ethics committee to an apex committee, there was no clarity on how companies found violating the rules would be penalised.

 

“There are no specific penal provisions in the code for unethical marketing by the companies,” FMRAI said in its statement in 2024.

 

A Delhi-based pharma executive said the process of escalating complaints to the apex committee remained complex and opaque.

 

The FMRAI had approached the Supreme Court in 2021 seeking to make the UCPMP statutory.

 

The apex court had then directed the Centre to respond. The government subsequently constituted a High-Powered Committee (HPC) chaired by Vinod K Paul, member (health), Niti Aayog. “Till date, no one has any clue as to what the said committee has done. In the meantime, freebies offered by the companies continue to flow freely in the market,” the FMRAI had alleged in its statement in 2024.