New Delhi, Jul 2 (PTI) The Delhi High Court on Wednesday asked the Drug Controller General of India to consult experts and relevant stakeholders in deciding a plea over drug combinations sold in the market for weight loss treatment.
A bench of Chief Justice D K Upadhyaya and Justice Tushar Rao Gedela asked the petitioner to give a representation to the DGCI, which was asked to decide the matter within three months.
A plea filed by Jitendra Chouksey said licenses issued for the use and sale of such drugs were not based on adequate data.
In an apparent reference to the recent death of popular TV actor Shefali Jariwala, the court said, “See what happened two-three days back…” News reports suggest Jariwala was taking anti-ageing treatment for the last several years.
The petitioner claimed the licenses have been issued without conducting any specific trials and studies and without noting the serious adverse health effects of the drugs.
“These drugs were originally developed and internationally approved for the treatment of Type 2 Diabetes Mellitus, with their primary therapeutic role being the regulation of glycemic levels. However, over the past few years, they have been repurposed and approved often through accelerated pathways for obesity treatment and chronic weight management, based largely on short-term efficacy trials,” the plea said.
It said under the Drugs and Cosmetics Act, it is the DCGI which is the competent and statutory authority entrusted with taking appropriate measures to ensure safe use of drugs.
The petitioner said representations were made on April 18 to the Centre and DCGI on the issue.
The court, however, said the plea’s concerns have to be first looked into and addressed by the DCGI as it allowed the petitioner to move the authority by way of an additional representation and bring relevant material and documents to its notice.
The additional representation was directed to be submitted to the DGCI within a fortnight.
“In case such an additional representation is preferred enclosing all the documents and material necessary for addressing the issue raised in the writ petition, the same shall be attended to and considered appropriately and as per law by the authority concerned,” the court said.
The order added, “DCGI shall consult experts as also other stakeholders such as manufacturers of the drugs in question.” PTI SKV SKV AMK AMK
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