INDIA – The central government has formed a five-member committee led by V K Paul, member (health) of NITI Aayog, to review the marketing practices of pharmaceutical companies in the country.

S Aparna, secretary in the 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. Currently, publicity and promotion by pharma companies is supervised under the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), the Indian Medical Council Regulations, 2002, and also by the Central Board of Direct Tax.

The department of pharmaceutical (DoP’s) Universal Code of Pharmaceutical Marketing Practices (UCPMP) for pharmaceutical firms came into effect in January 2015.

UCPMP aims to prevent unethical practices by pharmaceutical companies. It governs the conduct of pharmaceutical companies in terms of marketing, duly covering the various aspects including samples and gifts.

The code also has guidelines on provisions related to hospitality and cash or monetary grants to physicians and their families.

The UCPMP is voluntary and there is no legal penalty for violating the code. The Supreme Court is hearing a plea seeking direction from the government to give the UCPMP a statutory basis.

The Indian Medical Council Regulations, 2002, details professional misconduct by medical practitioners, including accepting gifts from drug companies and commissions from laboratories.

The rules under Central Board of Direct Tax require pharma companies to file details on how much they spend on promotion and publicity.

The Supreme Court has also ruled that gifts to medical practitioners by pharmaceutical companies are not allowable expenditure under the Income Tax Act, 1961.

Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance (IPA), lauding the move said, “This will be a good step as currently there are multiple codes that govern marketing practices of pharma companies leading to confusion.

This move hopefully will help companies to know more clearly what’s allowed and what’s prohibited. It will be good to have a unified code on the subject.”

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.

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.

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.

The committee is expected to submit its recommendation within the next three months.

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