‘Why weight-loss campaigns downplay exercise and diet?’ Indian drug regulator cracks whip

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has cautioned pharmaceutical companies against directly or indirectly promoting prescription medicines used to treat obesity and metabolic disorders to the general public.

In an advisory issued on Tuesday, the national drug regulator warned that surrogate advertisements and promotional campaigns linked to GLP-1 receptor agonists — a class of medicines used for diabetes and weight management — could invite regulatory action under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.

GLP-1 receptor agonists are medicines that mimic a natural hormone in the body which helps control blood sugar, slows digestion and reduces appetite. Because of these effects, doctors sometimes prescribe them for people with type-2 diabetes or for medically supervised weight-loss treatment.

The regulator said manufacturers and importers must ensure that the manufacture, sale, distribution and promotion of drug products strictly follow approved indications, labelling requirements and other statutory provisions.

Regulator flags indirect promotion through campaigns

According to the CDSCO, it has come to its notice that certain pharmaceutical companies may be carrying out direct or indirect promotional activities linked to GLP-1 receptor agonists.

These activities include disease awareness campaigns, digital media outreach and other communications that could lead to indirect promotion of such prescription medicines.

The regulator clarified that prescription drugs must only be prescribed by registered medical practitioners or specialists in accordance with approved indications and the conditions of marketing authorisation.

The notice warned that any advertisement promoting prescription-only medicines to the public — including claims that exaggerate therapeutic benefits, promise guaranteed weight-loss outcomes or induce demand for drug therapy — may be treated as misleading promotion.

It also cautioned against campaigns that minimise the importance of lifestyle interventions such as diet, exercise and behavioural changes in managing obesity.

Obesity care must include lifestyle measures

The CDSCO emphasised that obesity is a chronic metabolic condition that requires comprehensive management, including lifestyle interventions.

Pharmaceutical treatment, where medically indicated, should not be projected in a manner that undermines public health initiatives promoting diet control, physical activity and preventive healthcare measures, the advisory said.

It added that promotional activities presented as “awareness campaigns” but functioning as surrogate advertisements for prescription medicines would be viewed seriously and treated as irrational or misleading marketing practices.

Compliance directions issued to drug companies

The regulator directed all manufacturers, importers and marketing authorisation holders to ensure strict compliance with regulatory provisions.

According to the advisory, prescribing and patient information documents must prominently display details of authorised personnel and office codes. These documents must also include a dedicated contact number and a complaint or ticket reference mechanism to address consumer queries.

The CDSCO further said advertisements — including surrogate promotions — across print, electronic, digital or social media platforms are strictly prohibited if they promote prescription drugs to the public.

Companies have also been asked to submit comprehensive Risk Management Plans to ensure continued safety monitoring and appropriate risk-minimisation measures.

The advisory stated that all stakeholders must adhere to these directions in the public interest.