Freebies To Doctors | Supreme Court Calls For Giving Statutory Force To Code Of Pharmaceutical Marketing Practices

The Supreme Court on Tuesday(November 18) pressed the Union government on whether it intends to give statutory backing to the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), 2024, observing that the voluntary regime places consumers at a disadvantage and offers no effective enforcement mechanism against misconduct by pharmaceutical companies.While Additional Solicitor General KM Nataraj stated that the 2024 UCPMP is a shift to a mandatory regime from the completely voluntary 2015 UCPMP, Justice Mehta observed that the Ethics Committee structure in the 2024 Code remained industry-controlled. “Ultimately, what is the control of the government?”, he asked, adding, “Simple solution would be to bring the control order (under Essential Commodities Act). Incorporating the UCPMP in form of a control order will give it teeth.”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 asked the petitiioner, the Federation of Medical and Sales Representatives Associations of India (FMRAI), to give suggestions on how a statutory mechanism could work, and indicated that the Court may issue guidelines to regulate pharmaceutical marketing practices till a statutory framework is created.“The court would like you to at least tell us as to what should the Code be like, how it should work. The procedure, higher forums will need to be provided or not? And if provided, who should deal with the complaint. Who should do that enforcement, what is the mechanism for that? And then some guidelines like Vishakha, perhaps then subsequently can take shape”, Justice Mehta said.Senior Advocate Sanjay Parikh for the petitioners said the present legal regime penalises only doctors for accepting gifts and benefits, while pharmaceutical companies offering such inducements face no statutory consequences. He said this anomaly enables practices that result in irrational prescriptions, high-priced drugs and irrational combinations harmful to patients, violating the right to health under Article 21.He submitted that nearly 47% of drug combinations in the market were reported as irrational, many reappearing despite repeated bans. He referred to the 59th report of the Rajya Sabha and other documents indicating collusion between manufacturers, medical experts and regulatory officials.ASG KM Natraj submitted that the newly revised UCPMP 2024 substantially addresses all the issues raised by Parikh. He said the Code now provides for ethics committees, complaint portals, appeal mechanisms, auditors, penalties including suspension or expulsion from associations, reprimands, etc.He submitted that these measures convert the Code from a voluntary system into an “enforceable, system-backed framework.” He said that these measure are in addition to the mechanism provided under the Drugs and Cosmetics Act.However, the Justice Mehta pointed out that there is no statutory remedy available to consumers and patients. He noted that prosecutions under the Drugs and Cosmetics Act lie exclusively with drug inspectors, and a consumer or a patient doesn't have access to that mechanism. He asked how an ordinary person could utilize the Act to challenge unethical marketing practices. When Natraj submitted that consumers could file complaints under the UCPMP, the bench pointed the requirement of a ₹1,000 deposit and difficulties in obtaining information such as names of company directors. “Complaints under the Drugs and Cosmetics Act, your complaints, fail because you can't get information about the directors of the company. 90% of your complaints fail because of that only. What do you expect the consumer to do? If you brought out a code, why shouldn't that code be having appropriate measures whereby the consumers have a convenient mechanism for lodging their complaints and ensuring that action is taken against the individuals or the companies?” Justice Mehta asked.He further opined that the new UCPMP, though purportedly mandatory, is actually “almost voluntary”, as there is no government control.Referring to earlier government statements acknowledging the ineffectiveness of a voluntary code, the Court asked the ASG whether the Union intended to bring forward a statutory mechanism. The Court noted that a draft Drugs (Control Marketing) Order was proposed in 2017 under the Essential Commodities Act but never enacted.Justice Mehta said a simple solution would be to issue a statutory control order incorporating the Code. The ASG stated that he would take instruction from the government on the possibility of a more rigorous mechanism.Ultimately, the Court granted time for parties to submit their suggestions and for Nataraj to take instructions from the government, and list the matter on December 16.In May 2025, the Court orally remarked that the issue of pharmaceutical companies bribing doctors...

Freebies To Doctors | Supreme Court Calls For Giving Statutory Force To Code Of Pharmaceutical Marketing Practices

Amisha Shrivastava

The Court was hearing a PIL seeking to curb practice of pharma companies giving freebies to doctors to push their drugs.

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