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India Today
a day ago
- Health
- India Today
Karnataka seeks central probe into clinical trial lapses at HCG hospitals
The Karnataka government has written to the Central Drugs Standard Control Organisation (CDSCO), requesting an investigation into alleged irregularities in clinical trials conducted at the Bengaluru-based Healthcare Global Enterprises Ltd (HCG) hospitals. The move follows concerns raised by Justice P Krishna Bhat, a retired judge and former chairperson of the hospital's Institutional Ethics Committee (IEC) regarding patient safety and procedural violations during trial to the media, Karnataka Health Minister Dinesh Gundu Rao said the decision to seek an inquiry stemmed from troubling reports. 'This is based on certain information we saw and received, including some news articles, and then we found out there were some issues. This is a very serious issue, and it has been raised by the ethics committee of HCG Cancer Hospital itself by their own committee, chaired by Justice Krishna Bhat,' he said. He added that the Health Commissioner has already written to the Drug Controller General of India. 'We have asked them to look into the issue and investigate the matter, because it has serious implications regarding clinical trials and related concerns. I do not know what the truth is behind the whole thing, but it must be investigated by a responsible agency, and that is the CDSCO,' Rao BS Ajai Kumar, Founder and Chairman of HCG hospitals, responding to the allegations, issued a statement reiterating the hospital's adherence to all regulatory frameworks. 'We have noticed some unverified information about HCG, a pioneer in cancer care in India and Africa. We assure you that we strictly adhere to all guidelines set by regulatory authorities, including the Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR). Currently, we are successfully conducting a significant number of trials with utmost transparency, prioritising patient safety, approved by our Ethics Committee. Our commitment to delivering exceptional care remains unwavering,' Dr Ajai Kumar said on behalf of Healthcare Global Enterprises of the concerns were outlined in a letter dated June 30, 2025, by Health and Family Welfare Department Commissioner Sivakumar K B, who highlighted issues raised by Justice Bhat. These included unchecked conflicts of interest and irregularities in patient enrolment during trials, as reported by South letter, addressed to the Drugs Controller General of India, stated: 'These concerns have been flagged by none other than the chairperson of the institutional ethics committee, who has subsequently resigned.' It added: 'These lapses, if proven, will undermine the strict ethical principles laid down by the CDSCO, Department of Health Research, Indian Council of Medical Research, and global regulatory bodies like the World Health Organisation, which mandate the highest standards of patient safety and ethical conduct in clinical trials.'advertisementThe Commissioner described the matter as 'of serious concern' and called for a thorough probe into the allegations of 'unfair clinical trials being conducted at Bengaluru's HCG.'Justice Bhat had raised multiple concerns with then Chief Executive Officer Raj Gore and former Medical Director Dr Harish Reddy following discussions in several ethics committee meetings, in a March 5, 2025, letter, which was accessed by South of the most serious issues was a potential conflict of interest involving Dr Sathish, who allegedly served as both principal investigator and in a supervisory role as Director of the Ethics Committee. Justice Bhat wrote that this dual role posed ethical risks, including compromised patient safety, dilution of inclusion criteria, and resistance to procedural letter noted that although there is no formal post of 'Director of Clinical Trials' within ethics committees, institutions may appoint someone as 'Director of Clinical Trial Development' at the corporate level, typically endorsed by top leadership. Justice Bhat stated that during the 18 committee meetings he attended, the individual never clarified that he was not serving in such a dual concerns listed in the letter included rushed presentations, bypassing informed review processes, an excessive number of poorly explained trial proposals, and direct communication between the investigator and sponsors, which could open the door to commercial bias and protocol manipulation.- Ends IN THIS STORY#Karnataka#Bengaluru
Mint
a day ago
- Health
- Mint
Bigger fonts, clearer tags: How the drug regulator is looking to redesign hard-to-read medicine labels
New Delhi: Ever squinted at a medicine strip trying to find the expiry date, or popped a pill without knowing whether it's branded or generic? You're not alone. India's top drug regulator is stepping in to change that. The Drug Controller General of India (DCGI) is working on a nationwide overhaul of medicine packaging and labelling norms. The goal is to make expiry dates and batch numbers easier to read, reduce confusion between generic and branded drugs, and help patients, make better-informed choices, two government officials aware of the matter said. As part of the proposed changes, manufacturers may soon be required to use larger fonts, ditch shiny packaging that reflects light and obscures print, and print expiry dates in more than one place to prevent vital information from being torn off. There's also a plan to introduce a universal symbol to clearly distinguish generic medicines from branded ones. The regulator had received several complaints regarding the difficulty in differentiating between cheaper generic drugs and their branded counterparts, and consequently, the pricing comparison. "The drug regulator has received various complaints and demands from the consumers regarding the labelling of medicinal products such as tiny font size of the letters printed on the drug packaging, shiny labels, the expiry date of the medicines getting torn while taking out the medicine, and demand for universally recognised symbol on the generic medicines that will distinguish it from the branded medicines," said one of the officials cited above requesting anonymity. A sub-committee, set up by the DCGI, is reviewing the proposals and is expected to submit its report soon, the second official said. The committee is also examining ways to incorporate these changes under the Drugs and Cosmetics Rules, 1945, which governs the quality of drugs manufactured, imported, and sold in the country. Queries sent to the health ministry on Monday and DCGI spokesperson on Tuesday remained unanswered till press time. Also Read: India's drug regulator plans overhaul of Schedule H for prescription medicines Branded vs generic While both generic and branded medicines contain the same active ingredient and are expected to have the same therapeutic effect, their key differences lie in cost, brand recognition, and patent status. Branded medicines such as a well-known painkiller, often carry a higher price tag due to the research, development, and extensive marketing by the innovator company. Generic medicines, on the other hand, are typically much cheaper (often 80-85% less) because they are manufactured after the original drug's patent expires, eliminating the need for costly R&D and marketing. For instance, if 'PainRelief Pro' is a popular branded drug for headaches, its generic equivalent, say 'Paracetamol 500mg', will offer the same relief at a fraction of the cost. But customers often miss this. They ask for affordable, quality medicines but are often unaware of generic alternatives, said Rajiv Singhal, president and General Secretary of the All India Organization of Chemists and Druggists (AIOCD) representing 1.2 million members in the country. He called for expiry and batch details to be printed in clearer, larger fonts in multiple places to prevent accidental torn off. 'If this regulation comes into play, companies will have to mandatorily follow," he said, emphasizing the importance of regulatory enforcement. The development assumes significance given that India holds the distinction of being the world's largest supplier of generic drugs, accounting for approximately 20% of the global supply and manufacturing around 60,000 generic brands across 60 therapeutic categories. Mint had earlier reported that DCGI was considering Braille labelling on drug packaging to support the 4.95 million blind and 70 million visually impaired people in India. Global standards Globally, drug labels tend to be much simpler. Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association (IDMA), said Indian medicine strips are detailed compared to their international counterparts. For example, international labels often only state the tablet's name, omitting details like coating information or the explicit phrase "to be sold on the prescription of registered medical practitioners." Instead, the "Rx" symbol is commonly used to indicate a prescription requirement, with its absence signifying an over-the-counter (OTC) drug. The extensive information and specific font size requirements on Indian labels are seen as cumbersome, leading to substantial inventory costs and a significant financial burden on companies for redesigning packaging, Shah said. He said that the industry is open to changes for the greater good and informed that IDMA had previously submitted its representation to the DCGI years ago, suggesting simplified labelling. He said that a key hurdle to such changes is the significant inventory held by pharmaceutical companies. Changes to labelling would require a phased approach to avoid disruption. 'Any future changes, whenever and however implemented, should consider suggestions from both patients and the industry, and be introduced in a phased manner to minimize disruption." This step will empower patients and enhance transparency in the Indian pharmaceutical market, said Nikkhil K. Masurkar, CEO, Entod Pharmaceuticals. The current lack of visual cues on packaging, he said, often leaves patients unaware of generic alternatives. The government's Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) may also benefit from the labelling overhaul. PMBJP operates over 17,000 Janaushadhi Kendras across India to offer quality generic medicines at affordable rates. Also Read: Centre orders thorough safety review of painkiller Nimesulide for adults India's pharmaceutical market, meanwhile, continues to expand. According to Pharmarack, the Indian Pharmaceutical Market (IPM) reached ₹19,720 crore in sales for May 2025, showing a 7.2% YoY growth. On a moving annual total (MAT) basis, the industry posted ₹2.29 trillion, reflecting an 8.1% annual growth and 9.8% CAGR. While pharma companies may face some logistical costs in updating their packaging, the industry believes these are manageable and worth the impact on patient safety, affordability, and transparency.
The Hindu
2 days ago
- Health
- The Hindu
Delhi High Court asks DGCI to decide on plea against licensing of weight-loss drugs
The Delhi High Court asked the Drug Controller General of India (DCGI) on Wednesday (July 2, 2025) 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, Jitendra Chouksey, to give a representation to the DGCI, which was asked to decide the matter within three months. Mr. Chouksey, in his plea, alleged licenses issued for the use and sale of such drugs were not based on adequate data. The court, however, said the plea's concerns have to be first looked into and addressed by the DCGI. It allowed Mr. Chouksey to move the authority and bring relevant material and documents to its notice. Lack of clinical trials The plea raised concerns regarding the manner in which 'Glucagon-like peptide-1 receptor agonist (RA) drugs, specifically semaglutide, tirzepatide, and liraglutide, have been granted marketing approval in India for use in weight management and aesthetic treatments, despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism.' It claimed that 'numerous studies have further highlighted the significant risks posed by these medications, including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy.' The plea said 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,' it added. The plea said, 'In India, the CDSCO (Central Drugs Standard Control Organisation) has recently approved these drugs for weight- loss purposes without requiring large-scale clinical trials specific to Indian demographics or mandating post-marketing surveillance.' Mr. Chouksey said there is no evidence to suggest that these drugs have undergone rigorous safety evaluation within the Indian population. He cautioned that pharmaceutical companies, clinics, and digital wellness platforms are promoting the drug combinations as 'quick-fix' weight-loss solutions.
New Indian Express
24-06-2025
- Health
- New Indian Express
Novo Nordisk rolls out its much-awaited obesity drug Wegovy in India
CHENNAI: Danish drugs and insulin maker Novo Nordisk launched Wegovy, its latest and the much-awaited weight-loss drug -- a once‑a‑week semaglutide injection, in India today (June 24). The drug is currently being distributed and will hit pharmacies by the end of June. The Drug Controller General of India (DCGI) had in February 2025 approved Wegovy for chronic weight management and to reduce cardiovascular events after a select trial. According to the company, the five dose strengths of the obesity drug are available in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg, and the starter doses (0.25–1 mg) will cost Rs 4,366/week ($50.7), or about ₹17,345/month. While, the higher doses -- 1.7 mg and 2.4 mg are priced at Rs 24,280/month and Rs 26,015/month respectively. According to industry sources, the company advanced the India launch, which was originally planned for 2026, to mid‑2025 to stay ahead of rivals like Eli Lilly's Mounjaro. Novo aims to reach $1 billion in Indian sales within 5–7 years, signaling high confidence in demand, the sources say.
Mint
23-05-2025
- Health
- Mint
Govt to direct makers of lice lotion lindane on safe use, disposal labelling
New Delhi: The Centre is set to direct manufacturers of lindane, an insecticide used to treat scabies and lice infestations, to put clear labels on the containers to educate consumers about the drug use and its safe disposal, a government official said. The Drug Controller General of India's (DCGI) move follows concerns about lindane misuse in humans. To be sure, lindane is not prohibited in India, and is allowed to be sold as lotion and shampoo for human use. With a domestic production capacity of 1,300 tonnes per annum, India is a major exporter of the drug. Also read: New check for old drugs as Centre reviews safety In January this year, the Union health ministry received a communication from the ministry of environment, forest & climate change regarding lindane, highlighting that Stockholm Convention is a global environmental treaty that aims to protect human health and the environment from persistent organic pollutants (POPs). India is a signatory to the convention. Lindane is listed under the Stockholm Convention on persistent organic pollutants. PoPs are toxic chemicals persist in the environment for long periods, resisting degradation through natural processes. They can remain in the soil, water, and air for years or even decades. They accumulate in living organisms and pose risks to human health and ecosystems. Also read: An influencer gained followers as she documented her weight loss. Then she revealed she was on a GLP-1 The matter was taken up at the Drugs Technical Advisory Board meeting in April chaired by the Director General of Health Services (DGHS). The minutes of the meeting, reviewed by Mint, stated that the board also observed that topical preparation of lindane is used as a second-line treatment for scabies and lice infestations and Stockholm Convention also permits such use. Scabies is a contagious skin condition caused by tiny mites that burrow under the skin, causing intense itching and a rash. Queries sent to the health ministry remained unanswered till press time. In India, lindane formulations are registered for use in pharmaceutical products for control of head lice and scabies on people and sold under different brand names. Also read: Why America has not passed a law to treat addiction better 'Lindane is an affordable and effective drug for the treatment of scabies and lice infestations and recommended for continued marketing of drugs. So, the plan is to issue the guidance note for the manufacturer for safe disposal of the drug at all levels including instruction on the label," said the official aware of the matter. According to the official, unsafe disposal of leftover lindane has led to several cases of accidental misuse in homes.
