‘Decide within 3 months': Delhi HC tells CDSCO on plea against use of diabetes drugs in weight management
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.
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Business Standard
36 minutes ago
- Business Standard
Delhi HC dimisses 200+ defence ministry pleas against disability pension
The Delhi High Court has dismissed over 200 petitions of the Ministry of Defence challenging the Armed Force Tribunal's order holding a number of defence personnel entitled for disability pension for their respective disabilities. Disability pension cannot be denied to defence personnel solely on the ground that the onset of the disability occurred while they were posted at a peace station or by contending that it is a lifestyle disease, it said, while noting that military service is inherently stressful due to a combination of factors. A bench of Justices Navin Chawla and Shalinder Kaur said that granting disability pension is not an act of generosity but a rightful and just acknowledgement of the sacrifices endured by defence personnel which manifest in the form of disabilities/ disorders suffered during their military service. The purpose of granting disability pension to personnel of the Indian Armed Forces is to provide necessary financial support to those who have sustained a disability or illness during the course of their service due to service conditions, the bench said in its 85-page common judgment passed on July 1. The court said such the pension ensures that a soldier who suffers injury or disability due to service conditions is not left without support and is able to live with financial security and dignity. It is a measure that upholds the States responsibility towards its soldiers, who have served the nation with courage and devotion, it added. The court said it must be kept in mind that armed forces personnel, in defending the nation from external threats, have to perform their duties in most harsh and inhuman weather and conditions, be it in far-flung corners of land, in terrains and atmosphere where the limits of a man's survival are tested, or in air or water, where again surviving each day is a challenge, away from the luxury of family life and comforts. The central government, through the Ministry of Defence, challenged the tribunal's orders on the grounds that the Release Medical Board (RMB) had clearly opined that the medical condition of the defence personnel suffering from hypertension and Diabetes Mellitus Type II was neither attributable to nor aggravated by military service. The ministry contended that these personnel were not entitled to disability element of pension. 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The psychological burden of being away from family, living in isolated or challenging environments, and coping with the uncertainty of sudden transfers or duties adds to this strain. Additionally, the toll of continuous combat training further contributes to mental fatigue, it said. Despite the absence of active conflict or the challenges of hard area postings, the demanding nature of military life at peace stations can significantly impact the overall well-being of personnel, the court said, adding that even when not on the front lines or in hard areas, soldiers are aware that the threat is never far away. This environment, where danger is a constant reality for their peers and could become their own at any moment, creates a persistent state of mental and emotional strain that cannot be overlooked. "Thus, military service, whether in peace locations or operational zones, inherently carries stress that may predispose Force personnel to medical conditions such as hypertension, the bench said. The court said lifestyle varies from individual to individual and a mere statement that a disease is a lifestyle disorder cannot be a sufficient reason to deny disability pension, unless the medical board has duly examined and recorded particulars relevant to the individual concerned. When force personnel have rendered prolonged military service, there exists a substantial onus on the RMB to establish that the hypertension is not attributable to or aggravated by military service, it said. The court said the authorities have ignored that many of these soldiers had previously served in the field or hard areas, only to be diagnosed with their respective disabilities later during their peace postings. Denying benefits under such circumstances not only undermines their service but also fails to acknowledge the effect of their demanding careers, it said. The court said the possibility cannot be ruled out that these factors jointly and severally can become a chronic source of mental stress and strain, precipitating various medical conditions such as hypertension. It said the RMB must not resort to a vague and stereotyped approach but should engage in a comprehensive, logical, and rational analysis of the service and medical records of the personnel, and must record well-reasoned findings while discharging the onus placed upon it. The matters pertaining to Diabetes Mellitus Type II in which the RMB has opined that the disease is not attributable to or aggravated by military service, solely based on the fact that the onset was at a peace station, cannot be sustained, the court said. 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India Today
3 hours ago
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Salute to sacrifice: How disability pension for armed forces veterans won legal sanctity
The Delhi High Court, in a landmark verdict, has delivered a decisive blow to the ministry of defence's move to deny disability pensions to hundreds of retired armed forces personnel.A division bench of Justices Navin Chawla and Shalinder Kaur dismissed nearly 300 writ petitions, upholding the Armed Forces Tribunal's rulings in favour of the veterans. The pension claims were initially denied due to the disability being deemed 'Neither Attributable nor Aggravated' (NANA) by the competent medical board, as per the pension December, INDIA TODAY's story War Over The Wounded (edition dated December 16, 2024) had highlighted the issue wherein the ministry of defence resorted to filing hundreds of appeals in higher courts to challenge disability pensions to armed forces personnel by contradicting the government's stated policy to reduce defence ministers Manohar Parrikar and Nirmala Sitharaman had issued directives not to challenge tribunal orders granting disability benefits. Yet the ministry continued to file appeals, often against widows and disabled soldiers. For veterans, the percentage of disability is a critical factor that determines their pension and associated benefits. In September 2023, the ministry of defence revised the disability benefit rules, but clarified that the rule would apply only to those persons who retire after September 21, 2023, with no retrospective of defence staff General Anil Chauhan made it clear the disability pension-related rules had been revised to protect genuine soldiers' requirements. 'A study was [done] to protect the genuine interest of the personnel, who acquired disability during service, while preventing the exploitation of its liberal provisions from misuse,' he July 1, while delivering the order, the high court bench stated that the purpose of granting disability pension to personnel of the Indian armed forces was to provide necessary financial support to those who had sustained a disability or illness during their service, due to service conditions.'It is not an act of generosity but a rightful and just acknowledgement of the sacrifices endured by them, which manifests in the form of disabilities/disorders suffered during their military service. Such a pension ensures that a soldier who suffers injury or disability due to service conditions is not left without support and is able to live with financial security and dignity. It is a measure that upholds the State's responsibility towards its soldiers, who have served the nation with courage and devotion,' the court on behalf of the government, the attorney general informed the high court that in the present batch of petitions, none of the 'individuals has been out of service'. Consequently, not a single one of them is, per se, eligible to be considered for the award of disability pension. He further submitted that the Armed Forces Tribunal did not consider the revised entitlement rule of 2008 by the ministry of defence while passing on judgment. 'Such a departure from the provisions clearly enunciated by the government of India has rendered its policies on the subject completely irrelevant, redundant and ineffective,' the attorney general challenging the disability element to pensioners, the attorney general submitted that in the current cases, the disabilities of the respondents were assessed by the Release Medical Board (RMB) as well as by the competent/appellate authorities as neither attributable to nor aggravated by the military service, after considering their entire medical history and service concluding his stand, the attorney general stated that the medical board consists of experts who thoroughly assess individuals and their complete medical history in accordance with the relevant medical provisions. Based on this examination, they determine whether the disability can be considered attributable to or aggravated by military service. 'Therefore, the courts, within their limited scope of judicial review, should refrain from disputing the opinion of the medical board unless there is compelling medical evidence on record to contradict it,' he the court stated that it must always be kept in view that the armed forces personnel, while defending the country, have to perform their duties in extremely harsh and inhuman weather and conditions, wherein surviving each day is a challenge. It is, therefore, incumbent upon the RMB to furnish cogent and well-reasoned justification for their conclusions that the disease/disability suffered by the personnel cannot be said to be attributable to or aggravated by such service onus is not discharged by the RMB by simply relying on when such disability/disease is noticed also said that it must be noted that even in peace stations, military service is inherently stressful due to a combination of factors, such as strict discipline, long working hours, limited personal freedom and constant readiness for deployment. The psychological burden of being away from family, living in isolated or challenging environments, and coping with the uncertainty of sudden transfers or duties adds to this strain. The toll of continuous combat training further contributes to mental fatigue.'Despite the absence of active conflict or the challenges of hard area postings, the demanding nature of military life at peace stations can significantly impact the overall well-being of personnel,' the court said, adding that soldiers are always aware that threat is never far environment, wherein danger is a constant reality for their peers and could become their own at any moment, creates a persistent state of mental and emotional strain that cannot be overlooked. Thus, military service, whether in peace locations or operational zones, inherently carries stress that may predispose armed force personnel to medical conditions, including hypertension, the court to India Today Magazine- Ends
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Govt officials among 35 booked in pan-India medical colleges scam
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