New Delhi, March 24 To ensure ethical pharmaceutical practices in the supply chain of weight-loss drugs of the GLP-1 class, the Drugs Controller General of India (DCGI) has intensified its regulatory surveillance against the unauthorized sale and promotion of the medications.
To this end, inspections and audits have been carried out at many online pharmacy warehouses, drug wholesalers and retailers to check for unauthorized sale and improper prescription.
With the recent introduction of multiple generic variants of GLP-1-based weight-loss drugs in the Indian market, concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics, health ministry officials said on Tuesday.
These drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks.
Taking cognisance of the situation, the DCGI, in collaboration with state regulators, has initiated a series of targeted actions to curb possible malpractices across the pharmaceutical supply chain and prevent unauthorized sales and use.
On March 10, a comprehensive advisory was issued to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.
In recent weeks, enforcement activities were significantly scaled up.
Audits and inspections were conducted at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics, the health ministry said.
These inspections spanned multiple regions across the country and focused on identifying violations related to unauthorized sale, improper prescription practices, and misleading marketing. Further, notices have also been sent to defaulting entities.
"The regulator emphasizes that patient safety remains paramount. The misuse of weight-loss drugs without clinical oversight can lead to severe health complications. Citizens are advised to use such medications only under the guidance of qualified medical practitioners," the ministry said in a statement on Tuesday.
It is important to reiterate here that the drugs have been approved in India with the condition of prescription by only endocrinologists and internal medicine specialists, and for some indications, by cardiologists.
Regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly, with possible actions including cancellation of licenses, penalties, and prosecution under applicable laws, officials said.