Centre Proposes 3-Member Panel To Regulate Unethical Pharma Marketing: Supreme Court

The Bench of Justices Vikram Nath and Sandeep Mehta was hearing petitions filed by the Federation of Medical and Sales Representatives Associations of India (FMSRAI) and others, seeking regulation of unethical marketing practices in the pharmaceutical industry.

The Centre sought two months' time for the proposed committee to examine the issue and submit its report, which would subsequently be placed before the Supreme Court for consideration and approval.

Solicitor General Tushar Mehta, appearing for the Centre, submitted that detailed discussions had taken place among the concerned authorities and that there was a need to strengthen the existing mechanism.

The Centre said the proposed committee would examine whether a statutory framework was required and, if so, what form such a framework should take to ensure that pharmaceutical companies do not engage in unethical practices.

The government's submission stated that, until the committee submits its report and a decision is taken on its recommendations, the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024 would continue to govern the field.

The Bench, however, sought clarification on whether the proposed committee had actually been constituted.

When the Court asked, whether the committee had been constituted, the Centre's counsel said he would obtain instructions and inform the Bench.

The Centre also submitted that the issue involved several ministries and required consideration at an inter-ministerial level.

Senior Advocate Sanjay Parikh, appearing for the petitioners, questioned the delay in putting an effective regulatory mechanism in place.

He pointed out that the Centre's earlier counter affidavit, filed in September 2022, had stated that a high-level committee headed by a member of the Health sector of NITI Aayog had already been constituted to examine the need for a legally enforceable mechanism to regulate pharmaceutical marketing practices.

Parikh argued that nearly four years had passed since that undertaking and the Centre was now proposing another three-member committee.

He further submitted that the UCPMP 2014 and UCPMP 2024 were substantially similar, with the latter containing changes largely relating to headings and minor corrections.

The petitioners have sought directions from the Supreme Court for an effective mechanism to regulate unethical marketing practices by pharmaceutical companies. They had also urged the Court to frame guidelines until Parliament or the government enacted an appropriate statutory framework.

The Supreme Court had earlier raised concerns over whether the UCPMP 2024 had adequate enforcement mechanisms to regulate pharmaceutical companies.

The Court had also questioned whether the Centre intended to give statutory backing to the code, observing that the absence of effective government control could render a supposedly mandatory regulatory regime practically voluntary.

The Bench on Tuesday reserved its order on the petitions after hearing the submissions.

The petition had been filed in view of "the ever-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, which are practices that directly affect citizens' health, violating their rights under Article 21 of Constitution."