The Union government has defended the Universal Code of Pharmaceutical Marketing Practices (UCPMP) in the Supreme Court, saying the existing framework of the pharma industry’s promotional practices works adequately, as per the provisions of the code.
In the submission to the Supreme Court, N Yuvaraj, Joint Secretary, Department of Pharmaceuticals, Government of India, cited the Indian Pharmaceutical Alliance’s (IPA) investigation report clearing Dolo-650 maker Micro Labs of allegations of bribing doctors with freebies worth Rs 1,000 crore in one year to promote its popular antipyretic.
“These developments show that the existing Uniform Code on Pharmaceutical Marketing Practices (UCPMP) works adequately, as per the provisions of the Code,” the Centre’s response said. Moneycontrol is in possession of the Centre’s response.
The Pharma Joint Secretary added that the Department of Pharmaceutical (DoP) and National Pharmaceutical Pricing Authority (NPPA) have reviewed implementation of the voluntary code in various instances.
“NPPA has prepared a proforma for furnishing a quarterly return on complaints received and action thereafter by Industries Association as per para 8 of the UCPMP; the same has been circulated to associations for submission to NPPA within 30 days at the end of each quarter via email,” the government representation said.
The Centre’s submission in the apex court was on a plea by the Federation of Medical and Sales Representatives Associations of India (FMRAI) seeking direction to the government to give the UCMCP (Code) statutory basis and making it effective by ensuring a monitoring mechanism, transparency, accountability as well as consequences for violations.
The Centre’s reply to the Supreme Court stated that FMRAI’s writ petition gives an incorrect impression that the existing legal regime was insufficient and inadequate to protect citizens from unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals.
Also read: Doctor-Pharma Nexus Part II: What drives drug prescription in India?
“The existing legal regime consists of multifarious legislations which seek to cover and curtail such unethical practices by disincentivizing and penal measures,” the government said in its submission.
Statutory backing for UCMCP
Responding to FMRAI’s demand of providing a statutory backing to the UCMCP, the Centre said progressive steps to evaluate the necessity and measures of making the code statutory were being taken, adding that it was a ‘time-consuming process, which cannot be completed in haste’.
“The Respondents have been evaluating the necessity to make the Code statutory. However, it is pertinent to note that making the code statutory is a policy decision and a legislative act which necessitates extensive consultation between different ministries and government departments and requires an overall consensus,” the union government said in the reply.
Also read: Micro Labs gets clean chit from pharma body on allegations of spending Rs 1,000 crore on Dolo 650
The FMRAI knocked on the Supreme Court’s doors in August seeking central government action leading to a statutory code of ethical marketing practices, with penal consequences for unethical practices by pharma companies.
The response added that central government has formed a five-member committee led by V K Paul, member (health) of NITI Aayog, to examine the issue holistically and align interventions by various stakeholder Departments for effective implementation and also to examine all related issues on the requirement of a legally enforceable mechanism to regulate marketing practices with insights from practices across the globe.
“The committee is expected to give its recommendation within 90 days,” it added.
Guidelines not required
The Centre has urged the Supreme Court not to issue guidelines in the matter saying an enforceable legal regime exists to counter and control unethical medical practices.
The Joint Secretary said that the Pharma Department had undertaken exercises recently to examine all the present provisions, align various provisions and examine the requirement of a legally enforceable mechanism, if any, by constituting a high-level committee.
“Therefore, the writ petition does not make out a case for framing of any kind of guidelines or issuance of directions by this court in the exercise of its powers under Article 32, 142 or 144 of the constitution,” he added.
FMRAI to file reply
An FMRAI representative told Moneycontrol that the association would be filing a reply in the Supreme Court after assessing the Centre’s response.
“We are urging the Supreme Court to give a direction to the Central government on the need for such a legislation and not in any way compelling the state. The need for such a legislation is much more relevant now than ever before,” said Dr Gopal Dabade, Drug Action Forum, Karnataka.
Dabade said most drug manufacturing companies also fix targets for sales of these antibiotics through medical representatives.
The government needs to exercise its power and put regulations in place so that antibiotics are not pushed into the market to doctors by profit-driven drug companies, he added.
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