The government has constituted a high-level committee to hammer out a legal mechanism to address the issue of pharmaceutical companies giving inducements for promoting their drugs and products.
The five-member committee chaired by Dr VK Paul, NITI Aayog member (health) will also review various other issues about the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).
The panel includes the secretary of the department of pharmaceuticals S Aparna, Union health secretary Rajesh Bhushan, and Central Board of Direct Taxes (CBDT) chairman Nitin Gupta as members and a joint secretary (policy) from the department of pharmaceuticals as member secretary.
The committee was constituted on the recommendation of the Union Minister of Health and Family Welfare, Chemicals and Fertilizers, Mansukh Mandaviya.
An office memorandum issued on September 12 stated that the department of pharmaceuticals has also put in place a code of ethics, the UCPMP, for pharma companies, which has been in effect since January 1, 2015, and has been adopted by all the major pharmaceutical associations.
The code provides for the procedure of filing complaints, an inquiry by the Apex Committees of the Associations, penal actions, etc to be taken by the pharma association of which the company is a member.
The code is not enforceable under any law/statute of the government, the office memorandum read.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, under the Indian Medical Council Act, 1956, as amended from time to time, mention in detail the relationship of the healthcare professionals with pharmaceutical companies and prohibits the physicians and medical practitioners from committing such acts which are “unethical” in nature, the office memorandum stated.
The regulations also lay down the manner of enforcement in case complaints are received which violate these regulations.
The regulations are enforced by the National Medical Commission under the department of health and family welfare, duly involving state medical councils.
The memorandum also cited a CBDT circular, dated August 1, 2012, upheld by the Supreme Court in a decision on February 24, 2022, in Apex Laboratories Pvt Ltd Vs DCIT case as an “important development” regarding pharmaceutical marketing practices.
The circular, and the apex court’s decision on it, was also reiterated by the government through Finance Act, 2022, it said.
“Hence, to examine the issue holistically and align the interventions by various stakeholder departments and also to examine all the related issues on the requirement of legally enforceable mechanism for regulating marketing practices, a High-Level Committee is constituted,” the memorandum said.
The committee has been tasked with examining the provisions of stakeholder departments on pharmaceutical marketing practices and their effective implementation.
It will also “examine the related issues on the requirement of legally enforceable mechanism for regulating marketing practices, including the study of the practices across the globe.”
The committee will be submitting its recommendation within 90 days.