Supreme Court directs committee to submit recommendations within two months of first meeting, urges Centre to take early reasoned decision (Image Generated with AI)Underlining the need to regulate marketing practices of pharmaceutical companies, the Supreme Court on Thursday asked the Centre to set up a committee which would recommend to the government measures for putting in place a regulatory or statutory mechanism to curb their unethical conduct.A bench of Justices Vikram Nath and Sandeep Mehta directed that the committee be formed within 2 weeks, if not already put in place by the Centre, which had proposed setting it up.“The Committee so constituted shall undertake a holistic and comprehensive examination of all issues relating to unethical pharmaceutical marketing practices, including the adequacy of the existing statutory and regulatory framework, the efficacy of the mechanisms presently in place for monitoring, oversight and enforcement, and the measures required to ensure greater transparency, accountability and effective compliance, with a view to strengthening the regulatory framework and safeguarding the larger public interest,” the court said.The SC asked the Committee to “…submit its recommendations…within a period of two months from the date of its first meeting…”. It also asked the Centre to consider the recommendations “and take an appropriate and reasoned decision at the earliest”.The bench also sought a compliance affidavit from the Centre explaining what it had done in pursuance of Thursday’s directions.The order came on a PIL by the Federation of Medical and Sales Representatives Associations of India and others highlighting the “alleged prevalence of unethical marketing and promotional practices adopted by pharmaceutical companies in their dealings with healthcare professionals.”They contended that “such practices include, inter alia, direct or indirect monetary benefits, gifts, hospitality, sponsored travel, entertainment and other inducements extended to medical practitioners with a view to influencing their drug prescribing practices.”Story continues below this adThe petitioners said that “such practices have the potential to result in over-prescription or irrational prescription of medicines, prescription of drugs in excess of therapeutic requirements, prescription of irrational combinations of medicines and a preference for high-valued or over-priced branded medicines”.They added that the “consequences are not confined to an increase in the cost burden upon patients but extend to serious implications for public health, including adverse drug reactions, irrational consumption of medicines and the emergence of antimicrobial/antibiotic resistance.”The petitioners pointed out that while the medical profession is subject to statutory ethical restrictions, there is no corresponding enforceable regulatory regime under which pharmaceutical companies can be proceeded against for inducing or facilitating such conduct and this “regulatory gap has persisted notwithstanding repeated governmental recognition of the need to curb unethical pharmaceutical marketing practices”.They pointed out that the voluntary nature of the Uniform Code for Pharmaceutical Marketing Practices, 2015, formulated by the Department of Pharmaceuticals “has rendered it ineffective, there being no adequate statutory mechanism for monitoring, transparency, accountability or enforceable consequences for its violation”.Story continues below this adTheir plea sought “either the conferment of statutory force to the UCPMP or the laying down of appropriate guidelines” by the Court.The SC said in its order that the material placed before it “indicates that the existing framework has not proved entirely effective in preventing and curbing unethical practices in the pharmaceutical sector.”The court added, “In a sector which has a direct bearing upon the health and well-being of citizens, the efficacy of the regulatory framework cannot be assessed merely by the existence of prescribed norms; it must also be judged by their efficacy, implementation and enforcement,” it said.During the hearing, the Centre “proposed to constitute a Committee to comprehensively examine the issues arising in the present proceedings and to make recommendations regarding the appropriate statutory and regulatory framework for regulating the conduct of pharmaceutical companies.”