Latest news with #JitendraChouksey
The Print
a day ago
- Health
- The Print
Delhi HC asks DGCI to decide representation over weight-loss drugs
A plea filed by Jitendra Chouksey said licenses issued for the use and sale of such drugs were not based on adequate data. 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. 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. 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 This report is auto-generated from PTI news service. ThePrint holds no responsibility for its content.
Economic Times
a day ago
- Health
- Economic Times
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
Live Events (You can now subscribe to our (You can now subscribe to our Economic Times WhatsApp channel New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
Time of India
a day ago
- Health
- Time of India
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three months. The order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three months. However a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same grounds. The court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in question. Live Events Notably, Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making Ozempic. Victoza (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and obesity. Legal experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight management. The PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism. Fitness-tech entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it said. The drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
