The Supreme Court has issued notice in a plea filed by the Federation of Medical & Sales Representatives Association of India (FMRAI) seeking a Uniform Code of Pharmaceutical Marketing Practices and making it effective by providing a monitoring mechanism, transparency, accountability as well as consequences of violations.
The bench of Dr. Justice D.Y. Chandrachud and Justice Surya Kant said, “We’ll ask the Government what they propose to do.”
Senior Advocate Sanjay Parikh submitted that he has circulated a judgment delivered by Justice Ravindra Bhat, which pointed out after referring to a case which says if you are a bribe giver and taker, in the sense that the bribe giver here is a pharmaceutical company and bribe-taker are the doctors, then the doctors are punishable under regulation. “Pharmaceutical companies are saying they are not liable and the discussion starts. We have done the representation to the Union regarding this. Something has to be done.”
The petitioners are FMRAI, a national-level trade union with local units in 300 cities and towns of the country registered in 1963 under the Trade Union Act, 1926, National Coordinator of Jan Swasthya Abhiyan, an organisation involved in health-related issues, and has been working as the pharmaceutical industry’s watch since the last 40 years. Since 2005, the petitioners have been seeking effective prevention and control of unethical marketing practices in the pharma industry by way of an enforceable Code of Ethical Marketing.
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The petitioners are concerned about public health in view of the increasing instances of unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals resulting in the prescription of excessive and/or irrational drugs and a push for high-cost and/or over-priced brands. Corruption in the pharmaceutical sector endangers positive health outcomes and puts patients’ health at risk. Hence, the petitioner prayed for a statutory code of ethical marketing for the pharmaceutical industries.
The profession of pharmacy is a source of livelihood which inherits elements of sacrifice and service towards the ailing humanity. The manufacturing, sale and distribution of drugs are regulated by the Drugs and Cosmetic Act of 1940. However, there is no law enforceable which regulates the promotion of drugs by a pharmaceutical companies.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribes a code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from pharmaceutical companies but this does not apply to drug companies.
Though in 2009, the Government initiated a move to have a discussion with stakeholders to develop a mechanism to regulate unethical pharmaceutical marketing practices. As a result, a voluntary “Uniform Code of Pharmaceutical Marketing Practices” was introduced in 2015. The petitioners gave many suggestions to improve the Code by including penalty clauses and giving it statutory backing. On different occasions, the Government of India acknowledged that the menace of corruption existed in the industry and needed to be curbed.
In 2017, the Government sent a proposed draft Drugs (Control Marketing) Order 2017 under section 3 of the Essential Commodities Act, 1955 to the Ministry of Law, Department of Legal Affairs, yet the same has not been enacted.
Briefly, the PIL is filed before the Apex Court for the following reasons-
– Unregulated corruption in the pharmaceutical sector endangers positive health outcomes and puts health at risk resulting in violation of Article 21 of the Constitution. Ample evidence exists which proves that over-prescription of drugs and irrational combinations of drugs are injurious to health and prolonged use may lead to drug resistance, protracted illness and death.
– There is an obligation on the Parliament to enact a law to regulate unethical practices by pharma companies that affect the Right to Health of the people of India.
– If unfettered ‘promotion’ of drugs by pharmaceutical companies is allowed to continue, the day is not far when India will become the hub of adverse drug reactions, drug/ antimicrobial resistance, protracted illnesses and deaths.
– If no enforceable law is enacted to curb unethical sales promotion practices by drug manufacturers, a grossly anomalous situation will continue where no action is taken against a recalcitrant drug Company for the same misconduct for which doctors are severely punished, even while the misconduct was caused, encouraged, aided and abetted by the drug company which goes scot-free.
Matter returnable in 6 weeks.
Case Name- Federation of Medical & Sales Representatives Association of India Vs UOI