The matter has been posted for hearing on May 21
)
Delhi High Court seeks answers from regulators over alleged inaction on misuse of diabetes drugs like Ozempic for weight loss ahead of a flood of generics.
Listen to This Article
The Delhi High Court on Tuesday sought responses from the Central Drugs Standard Control Organisation (CDSCO) and the central government on a contempt plea alleging non-compliance with its earlier directions to assess concerns over the off-label use of certain diabetes medications, such as Ozempic, for weight loss.
Justice Sachin Datta issued notice and granted four weeks to the CDSCO, the Drugs Controller General of India (DCGI) and the Union government to place their replies on record. The matter has been posted for hearing on May 21.
The contempt proceedings stem from a public interest litigation (PIL) filed by Jitendra Chouksey, which had flagged the growing non-prescribed use of GLP-1 receptor agonists such as Ozempic (semaglutide), Mounjaro (tirzepatide) and Victoza (liraglutide) for weight management.
The petitioner had argued that in India, such medications were increasingly being marketed as rapid weight-loss solutions by fitness centres and clinics, with instances of access without valid prescriptions.
Chouksey’s plea also highlighted the lack of India-specific clinical evidence for their use in obesity management and warned of potential adverse effects, including pancreatitis, thyroid malignancies, cardiovascular complications and neurological risks.
In July 2025, while closing the PIL, the High Court had refrained from issuing blanket regulatory directions but asked the CDSCO to evaluate the concerns, consult relevant stakeholders and arrive at a considered decision within three months.
The court had also orally observed that drugs carrying serious health risks should not be freely available without prescription safeguards.
The hearing of the contempt petition comes just days before Danish drugmaker Novo Nordisk is expected to lose its exclusivity over semaglutide-based drugs on March 20, with more than 30 generic versions of the drug expected to be launched within one week of the patent expiry.
These drugs, though approved for type 2 diabetes, have witnessed a surge in demand globally due to their weight-loss effects.
According to the contempt petition, despite a supplementary representation submitted on July 13, 2025, along with supporting material, the regulator has not communicated a formal decision within the stipulated timeline.
The petitioner claims that only informal assurances indicating that the issue was “under consideration” were received, and repeated follow-ups failed to elicit a substantive response.
Alleging wilful non-compliance, the plea contends that the failure to decide within the prescribed period violates the court’s directions. Appearing for the petitioner, counsel submitted that no meaningful action had been taken for several months following the order, adding that even the limited response received came only after the contempt petition was filed and did not include relevant documents.
Taking note of the submissions, the court observed that the authority was required to decide on the representation and accordingly called for its reply.
“There are regulatory lapses which our team has identified, and we will be bringing them to court and the public’s notice in due time. We will also request an independent/CBI enquiry into the approval process,” Chouksey told Business Standard.
aniltikotekar4sme.com 