Latest news with #DevendraUpadhyaya
Hans India
02-07-2025
- Health
- Hans India
‘Decide within 3 months': Delhi HC tells CDSCO on plea against use of diabetes drugs in weight management
New Delhi: The Delhi High Court on Wednesday directed the Central Drugs Standard Control Organisation (CDSCO) to decide, within 3 months, a representation raising safety concerns on the usage of GLP-1-RA drugs in weight management and aesthetic treatment. A bench of Chief Justice Devendra Upadhyaya and Justice Tushar Rao Gedela was hearing a public interest litigation (PIL) against the manner in which Glucagon Like Peptide -1 Receptor Agonist (RA) (GLP-1-RA) drugs, specifically semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for weight loss and aesthetic purposes, despite being originally approved for treatment of Type 2 diabetes. The PIL, filed through advocate Rohit Kumar, referred to the significant risks posed by these medications, including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy. In its order, the CJ Upadhyaya-led Bench directed the PIL litigant to submit to CDSCO the scientific studies and data relied upon in the petition. Asking the CDSCO to decide the representation within 3 months, the Delhi High Court closed the proceedings and disposed of the matter. As per the petition, GLP-1-RA drugs were originally developed and internationally approved for the treatment of Type 2 Diabetes Mellitus, but over the past few years, have been "repurposed and approved often through accelerated pathways for obesity treatment and chronic weight management, based largely on short-term efficacy trials". Questioning the CDSCO's grant of marketing approval of these drugs for weight loss purposes in the country, the plea cited limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism. It said that there is no evidence to suggest that these drugs have undergone rigorous safety evaluation within the Indian population and highlighted the "aggressive" and "unregulated marketing" of these drugs for aesthetic and non-medical purposes. "Pharmaceutical companies, clinics, and digital wellness platforms are promoting semaglutide and tirzepatide as 'quick-fix' weight loss solutions, especially targeting younger populations, including teenagers. The increasing normalisation of these drugs in aesthetic medicine is alarming," added the PIL. Further, it said that the lack of transparency surrounding the clinical data submitted for approval of these drugs, the absence of publicly available safety profiles, and the regulatory silence on their off-label use violated the right to health, which encompasses the right to safe medication, informed decision-making, and access to scientific information.
Mint
22-04-2025
- Business
- Mint
Delhi HC orders govt response to LG, Samsung's e-waste payout challenge
The Delhi High Court (HC) has issued a notice to the government and the Central Pollution Control Board (CPCB) after LG Electronics India Pvt. Ltd and Samsung India Electronics Pvt. Ltd filed petitions against a recent policy requiring electronics manufacturers to pay more to electronic waste (e-waste) recyclers, court documents showed Tuesday. The division bench of chief justice Devendra Upadhyaya and justice Tushar Rao Gedela directed the parties to file their responses, with the next hearing scheduled for 16 May. The plea filed by LG Electronics in the Delhi HC, as seen by Mint, challenges the constitutional validity of amendments notified in September 2024 under the E-Waste Management Rules, 2022. These amendments mandate a minimum payout by producers to registered recyclers for extended producer responsibility (EPR) certificates: ₹ 22 per kg for general e-waste (such as TVs, washing machines, etc.) and ₹ 34 per kg for smartphone waste. India, currently the world's third-largest e-waste generator, only formally recycled 43% of its e-waste last year, according to government data. In its plea, LG contends that the pricing rules 'fail to take into consideration that merely fleecing companies and taxing them in the name of the 'polluter pays principle' will not achieve the government's objectives.' LG's main concern is that the rules impose unreasonable financial obligations on companies without adequate justification. The mandatory payments to recyclers, particularly the increased costs of compliance, are seen as disproportionate and harmful to business profitability. A major issue raised by LG is the arbitrary fixation of prices for EPR certificates. LG argues that these prices, significantly higher than previous years, lack a scientific basis and market analysis. The absence of clear guidelines for these prices creates ambiguity and makes it difficult for companies to comply. Furthermore, LG has criticized the rules for linking financial burdens to environmental compensation (EC) for non-compliance with EPR obligations. This, they argue, could result in excessive penalties for minor delays, creating financial challenges and potentially crippling companies, especially small producers. Another point of contention is the exclusion of the informal sector from the e-waste recycling framework. LG stresses that the informal sector handles a significant portion of recycling in India, and its exclusion undermines efforts to address the e-waste problem comprehensively. They advocate for a balanced approach that integrates both formal and informal recycling methods. According to Markets and Data, India's e-waste management market size was valued at $1.56 billion in fiscal year 2023 (FY23), which is expected to swell to $3.35 billion in FY31. India ranks as the world's third-largest e-waste producer after the US and China. In 2022, India generated approximately 1.6 million tonnes of electronic waste, which is likely to surge to 29 million tonnes by 2030. LG also raised concerns about the lack of consultation with industry stakeholders during the drafting of the amended rules. They argue that producers' concerns were not sufficiently addressed, resulting in a regulatory framework that does not align with the practical realities of e-waste management. Samsung Electronics and other companies, such as Indian air conditioner maker Blue Star, have also filed lawsuits challenging the rules, citing similar concerns over the compliance burdens. India's E-Waste Management rules were first introduced in 2016, making producers responsible for e-waste disposal. In 2022, the Union ministry of environment began revising these rules to address growing e-waste challenges. A draft for public consultation was released in November 2022, followed by the final amendments in April 2023. The updated rules, enforced in September 2024, introduced new recycling targets, penalties, and the minimum payout to recyclers, which led to the legal challenges. First Published: 22 Apr 2025, 08:13 PM IST
