The central government has formed a five-member committee led by V K Paul, member (health) of NITI Aayog, to consider a "legally enforceable" mechanism for regulating the marketing practices of pharmaceutical firms.
The committee is expected to submit its report in 90 days. 'Business Standard' has seen the memorandum issued on September 12 for its constitution.
S Aparna, secretary in department of pharmaceuticals (DoP); Rajesh Bhushan, secretary in the ministry of health and family welfare (MoHFW); Nitin Gupta, chairman of the Central Board of Direct Taxes (CBDT); and a joint secretary (policy) from the department of personnel (DoP) are the four other members of the 'high level' committee. Paul will be its chairperson.
The committee may bring in members from the law department if required, the memorandum said. It will examine the provisions government departments have to regulate pharmaceutical marketing practices and align interventions for implementation by the healthcare industry.
It will also “examine the related issues on the requirement of legally enforceable mechanisms for regulating marketing practices, including study of the practices across the globe.” It can look into any other matter it may deem fit on the subject matter.
Guidelines for pharmaceutical marketing already exist. The DoP’s Universal Code of Pharmaceutical Marketing Practices (UCPMP) for pharmaceutical firms came into effect from January 2015. The memorandum said the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which comes under the Medical Council Act, 1956 details the relationship between healthcare professionals and pharmaceutical companies.
The UCPMP is voluntary and there is no legal penalty for violating the code. The Supreme Court is hearing a plea seeking direction to the government to give the UCPMP a statutory basis.
Ramesh Sundar, president of the Federation of Medical & Sales Representatives Association of India, told 'Business Standard' that the government is dragging its feet in implementing implement the UCPMP, which codifies the dos and don'ts for promoting drugs and the role of medical representatives.
Civil society groups want a statutory UCPMP. Malini Aisola, co-convenor of All India Drugs Action Network (AIDAN), said the committee’s composition was correct. She called for reforming the Medical Council of India’s code. “There are gaping holes in the MCI code through which doctors can always take professional ‘fees’ for their ‘services’ rendered to pharmaceutical firms or associations. Those need to be fixed first,” she said, rejecting self-regulation by industry groups like the Indian Pharmaceutical Alliance.
“Firms should disclose publicly how much ‘fees’ they have paid to which healthcare professional for which ‘service’ and this should be made public from time to time. This one step would largely discourage firms from engaging in malpractices,” Aisola said.