The Delhi High Court has directed the Drug Controller General of India (DCGI) to consult medical experts and relevant stakeholders before taking a decision on the safety and approval of certain drug combinations being sold in India for weight loss treatment.
A division bench comprising Chief Justice D.K. Upadhyaya and Justice Tushar Rao Gedela issued the directive while hearing a plea filed by Jitendra Chouksey, who alleged that the current licensing of these drugs lacked sufficient clinical backing and posed serious health risks.
The court allowed the petitioner to submit an additional representation to the DCGI within two weeks, along with all necessary supporting documents and materials. The DCGI has been instructed to decide on the matter within three months of receiving the representation.
“These concerns have to be first looked into and addressed by the statutory authority,” the bench observed, emphasizing the DCGI’s responsibility under the Drugs and Cosmetics Act to ensure drug safety.
In a pointed reference to a recent tragic incident, the bench remarked, “See what happened two-three days back…” — an apparent allusion to media reports surrounding the sudden death of TV personality Shefali Jariwala, who was reportedly undergoing long-term anti-ageing treatment.
The petitioner contended that many of the drugs currently marketed for obesity and weight management were originally developed for treating Type 2 diabetes and were approved for their new uses based largely on short-term efficacy trials. He argued that their expanded use in weight-loss therapy lacked sufficient long-term safety data and had not undergone India-specific trials.
“The licenses have been issued without noting the serious adverse effects, and often without conducting any focused clinical studies,” the plea claimed.
The court directed the DCGI to engage with relevant experts and drug manufacturers during its evaluation process, stating, “DCGI shall consult experts as also other stakeholders such as manufacturers of the drugs in question.”
