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The Supreme Court today reserved order on a plea seeking statutory regulation of pharmaceutical marketing practices, after Solicitor General Tushar Mehta informed the Court that the Union government will constitute a three-member committee to examine whether a statutory framework is needed to regulate unethical practices by pharmaceutical companies.

“However, there is a need of strengthening mechanism to ensure that pharmaceutical companies do not indulge in any unethical practices. The detailed discussions having taken place and with a view to find out the possible solution, it is decided to constitute a 3-member committee requesting them to provide their report on the issues as to whether and if yes what can be the statutory framework to ensure that pharmaceutical companies also do not indulge into such unethical practices”, Mehta told the Court.

A bench of Justice Vikram Nath and Justice Sandeep Mehta was hearing a petition seeking statutory regulation of pharmaceutical marketing practices to curb unethical interactions between pharmaceutical companies and doctors.

The Court had earlier questioned whether the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024 had sufficient enforcement mechanisms. It had also questioned whether the Union government intended to give statutory backing to the Code, noting that the absence of government control could make the purportedly mandatory regime almost voluntary.

During that hearing, the Court had also pointed out that consumers and patients did not have a statutory remedy against unethical pharmaceutical marketing practices. It had questioned how an ordinary consumer could use the Drugs and Cosmetics Act when prosecutions under the Act are initiated through drug inspectors.

Today, SG Mehta referred to an affidavit filed by the Centre dated 17th August, 2026 and submitted that detailed deliberations had taken place between the Department of Pharmaceuticals, Department of Health and Family Welfare and Department of Legal Affairs.

He said that the government had examined two aspects – ensuring that medical practitioners do not indulge in unethical practices and ensuring that pharmaceutical companies do not engage in unethical practices to lure medical practitioners.

On the first aspect, Mehta submitted that the existing statutory and regulatory framework already provides for disciplinary action against registered medical practitioners for professional misconduct.

He referred to the Indian Medical Council regulations, which prescribe a code of conduct for healthcare professionals in their relationship with pharmaceutical and allied healthcare industries. The regulations prohibit doctors from receiving gifts, travel facilities, hospitality and cash or monetary grants from pharmaceutical and allied healthcare companies.

The regulations also prohibit doctors from abetting or committing such unethical acts and contain provisions concerning professional autonomy, endorsement of drugs and other relationships with pharmaceutical companies.

Mehta highlighted that violations can attract penalties ranging from censure to removal of the doctor's name from the Indian Medical Register or State Medical Register. Depending on the value of the cash, gift, travel facility or hospitality received, a doctor can be removed from the register for three months, six months, one year or more than one year, he submitted.

Turning to the second aspect concerning pharmaceutical companies, Mehta told the court that detailed discussions had taken place and the government had decided to constitute a three-member committee to examine whether a statutory framework was required and, if so, what it should contain.

Mehta said that he had requested that the committee submit its report within two months so that the government could take a decision. Until then, the UCPMP would continue to govern the field.

He also submitted that several factors would have to be considered, including the difference between large and small pharmaceutical companies. He claimed that large pharmaceutical companies had, by and large, stopped such practices, although such practices continued at some level among smaller pharmaceutical companies. He added that the pharmaceutical association was also in favour of some form of regulation to control such practices.

When, Justice Vikram Nath asked whether the committee had already been constituted, Mehta responded he would inquire into the matter and assured the Court that, if it had not been constituted, it would be done by tomorrow.

Senior Advocate Sanjay Parikh for the petitioners, however, questioned the delay in the process. He pointed out that the Union government's earlier counter affidavit, filed in September 2022, had stated that a high-level committee under the chairmanship of a Member, Health, NITI Aayog had been constituted to examine the need for a legally enforceable mechanism to regulate pharmaceutical marketing practices.

The committee had been given 90 days to submit its recommendations, Parikh said. He referred to the affidavit, which stated that making the UCPMP statutory was a policy decision and legislative act requiring extensive consultation between ministries and government departments and an overall consensus. The government had also stated that it had invited bids in October 2021 for a study on pharmaceutical marketing practices in India vis-à-vis global best practices, but the study could not be finalised because of issues concerning the scheme guidelines and high financial bids.

Parikh said that despite the earlier exercise, nearly four years had passed and the government was now proposing to constitute another three-member committee. He submitted that the UCPMP of 2014 and the present code were substantially the same, barring changes in headings and corrections to some sentences.

Parikh also highlighted the difference in the treatment of doctors who receive freebies and pharmaceutical companies that offer them.

He submitted that the existing regime penalises the doctor who accepts gifts, travel facilities, hospitality or other benefits, but does not impose a corresponding statutory penalty on the pharmaceutical company that gives the inducement. He said submitted that this gap in the law allows pharmaceutical companies to offer benefits to doctors to influence prescriptions.

Parikh submitted that there were two possible ways forward. Either the government should bring a statutory framework, or the Court should issue guidelines to fill the gap until legislation is enacted. He said that he had already submitted suggestions to the Solicitor General on what such a statutory framework should contain.

Advocate Shreya Meni also made submissions on the need for an effective regulatory mechanism. She supported the petitioners' concerns regarding the present framework and sought that the stakeholders' concerns and submissions be considered in the process of framing the proposed regulatory mechanism.

She referred to Rule 65(11A) of the Drugs and Cosmetics Rules and submitted that there was an inconsistency concerning the Pradhan Mantri Bhartiya Janaushadhi Pariyojana. She welcomed the government's proposal to come out with a statutory framework but sought an opportunity for stakeholders to participate in the proposed committee's meetings and deliberations.

Justice Nath said the committee would give the stakeholders an opportunity to place their concerns before it.

Advocate Kaleeswaram Raj referred to the Supreme Court's 2022 judgment in Apex Laboratories Pvt. Ltd. v. Deputy Commissioner of Income Tax, in which it was held that medical practitioners have a quasi-fiduciary relationship with their patients and prescriptions could be influenced by benefits offered by pharmaceutical companies.

The Court in that judgment had referred to pharmaceutical companies offering doctors freebies such as gold coins, electronic goods and funding for international trips or medical conferences. Raj submitted that the Court had described the resulting practice as a “publicly injurious cycle”.

Raj also referred to the Parliamentary Standing Committee on Health and Family Welfare's observations concerning generic medicines. He submitted that some mechanism was required in the interregnum while the government considered bringing statutory regulation, as the present UCPMP is voluntary.

Parikh also referred to the Apex Laboratories judgment and submitted that the Court had held that the prohibition against doctors accepting gifts and freebies also implied a prohibition against the giver of those benefits.

He urged the Court to pass appropriate directions in its order so that the process of framing a statutory mechanism would proceed and not be delayed further.

The Court ultimately reserved its order after hearing Parikh, Raj, Meni and Solicitor General Mehta.

Case no. – W.P.(C) No. 323/2021

Case Title – Federation of Medical and Sales Representatives Associations of India and Ors. v. Union of India and Ors.

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