CDSCO to intensify regulatory surveillance for anti-obesity drug after pharma companies announce local production

New Delhi: India’s apex drug regulator on Tuesday announced intensifying surveillance to prevent the misuse of popular anti-obesity medicine semaglutide after several local firms announced their plans to launch the drug’s cheaper generic versions in India.

“Regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws,” the Central Drugs Standard Control Organisation said in a statement.

In recent weeks audits and inspections were conducted at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics, it said.

The inspections spanned across the country and focused on identifying violations related to unauthorised sale, improper prescription practices and misleading marketing.

Further, notices have also been sent to “defaulting entities”, the CDSCO says without disclosing their identities.

With European major Novo Nordisk’s patent protection on semaglutide expiring in India last week, the companies announced they would locally manufacture cheaper generic version of the medicine (GLP-1 receptor agonist) that has emerged as the best-selling medicine not only for the treatment of diabetes-2 but also for obesity management.

But the anticipated introduction of multiple generic variants of GLP-1-based weight loss drugs in the Indian market, have evoked public health concerns regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics.

These drugs, the CDSCO says, when used without proper medical supervision, may lead to serious adverse effects and related health risks.

“The GLP-1 was initially used for diabetic management but was later found to have an impact on weight… But one should not consume it recklessly as these are serious medicines for a serious problem… People should be careful as there can be side-effects,” said Nikhil Tandon, a professor and head of the department of endocrinology at All India Institute of Medical Sciences here.

On March 10, the CDSCO issued a comprehensive advisory to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.

“The medicines used in weight control are always given with a foundation of diet control and physical activity. We have to make changes in our lifestyle first to achieve weight loss. After all this, if we are still not achieving the required weight, we should consult a doctor,” Tandon said.

Flagging the paramount importance of patient safety, the regulator said misuse of weight loss drugs without clinical oversight could lead to severe health complications and citizens should use such medications only under the guidance of qualified medical practitioners.

At least Indian pharmaceutical companies such as Torrent, Alkem, Sun Pharma, Dr Reddy’s Laboratories, Genmark, Natco Pharma, Zydus and USV have announced launching the generic medicine in India. Analysts expect more than 40 Indian drugmakers to launch over 50 brands in the coming weeks