DCGI cracks down on indirect promotion of weight-loss prescription drugs

New Delhi: The Drugs Controller General of India (DCGI) has directed all pharmaceutical manufacturers and importers to immediately stop surrogate, or indirect, promotion of prescription drugs, particularly targeting new weight-loss and metabolic disorder drugs, according to an advisory reviewed by Mint.

The directive, issued by the Central Drugs Standard Control Organization (CDSCO) on 11 March, signals a significant regulatory shift to protect public health from misleading marketing practices.

The advisory, issued by Rajeev Singh Raghuvanshi, India’s drugs controller general, comes after reports surfaced that pharmaceutical firms may be engaging in indirect promotional activities through social media, influencer engagements, and corporate campaigns.

“Any form of advertisement, whether direct or indirect, which promotes prescription-only medicines to the general public, exaggerates therapeutic efficacy, suggests assured or guaranteed weight loss outcomes, downplays lifestyle modification measures (diet, exercise, behavioural interventions), or induces demand for pharmacological therapy, may amount to misleading promotion and may attract action under relevant provisions of the Drugs Rules, 1945, including principles underlying Schedule J of the said rules,” the advisory stated.

Obesity is a chronic metabolic condition requiring comprehensive management, including lifestyle interventions, it said.

“Pharmaceutical therapy, where indicated, must not be projected in a manner that undermines public health initiatives promoting diet control, physical activity, and preventive healthcare measures,” it added. These promotional activities, often disguised as public health awareness, have been flagged for creating brand recall or product visibility for prescription-only medicines, which is a violation of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

Pharmaceutical companies such as Eli Lilly and rival Novo Nordisk recently stepped up multimedia awareness campaigns, working around Indian rules that prohibit the direct advertising of prescription drugs, as the race for India’s nascent but lucrative weight-loss drug market intensifies, Mint reported earlier. Drugs that require a prescription cannot be advertised in India under the Drugs and Cosmetics Act, 1940. Over-the-counter products such as antacids or pain balms can be promoted. Hence, prescription drugmakers rely on “awareness campaigns.”

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This prohibition shall extend to any form of direct or indirect promotional activity in print, electronic, digital, social media, or any other public platform that is intended, directly or indirectly, to promote the product to the general public. The DCGI specifically noted that any promotional activity carried out under the pretext of disease awareness or influencer engagement that creates product visibility shall be viewed seriously and treated as an irrational or misleading marketing practice.

Queries sent to the health ministry did not receive an immediate response.

“The science behind these (weight-loss) drugs is very solid and they are extremely effective, as seen in extensive clinical trials, but they are not a ‘clean’ solution and can have potential side effects. Because weight-loss is such an attractive proposition, we have seen a surge in popularity that likely drove the government to re-emphasize that these are not direct-to-public medications,” Dr. Ambrish Mithal, chairman, endocrinology department, Max Hospital, Saket, Delhi. “They must only be used under the strict prescription and supervision of a trained doctor. I totally agree that there should be no element of advertising drugs directly to people; surrogate or direct promotion should be curtailed to ensure these treatments remain in a clinical setting where a doctor decides the best course of action.”

The Indian anti-obesity market is currently dominated by global giants, including Eli Lilly and Novo Nordisk, which manufacture semaglutide.

The timing of the advisory is critical, as several domestic pharmaceutical companies are preparing to launch generic versions of semaglutide following its patent expiry in India in early 2026. This has triggered a rush to capture a market that is projected to grow significantly as India battles a rising obesity epidemic.

To improve transparency and accountability, the DCGI has mandated that prescribing information and patient information leaflets for prescription drugs must clearly display the details of authorised officials and an official office code so that responsible personnel can be easily identified. Furthermore, these documents must provide a dedicated contact number along with a complaint or ticket reference mechanism to address consumer queries and facilitate reporting. All manufacturers and marketing authorization holders are also required to submit a comprehensive risk management plan to ensure continued safety monitoring.

The CDSCO has marked a copy of this advisory to the Advertising Standards Council of India (ASCI) to ensure industry-wide compliance.