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Mint
7 days ago
- Health
- Mint
India's booming beauty industry has a serious problem of quality. New rules target this menace
New Delhi: India has tightened rules to ensure stricter testing and labelling of cosmetics to enhance safety, check counterfeit products and clearly define spurious items, said two officials aware of the development. A failure to comply with the new rules introduced by the health and family welfare ministry will result in the suspension and cancellation of licences, according to the officials cited earlier and documents reviewed by Mint. The Cosmetics (Amendment) Rules, 2025 were finalized and notified on 29 July after a detailed consultative process with the relevant stakeholders and further consultation with the Drugs Technical Advisory Board, a top drug advisory panel, said the first official quoted earlier. The changes include setting up a dedicated Central Cosmetics Laboratory to test products before they hit the shelves. India's cosmetics market—including skin, hair and oral care, fragrances, and colour products—is estimated at $20 billion, growing at an annualized rate of 25%, according to India Brand Equity Foundation. New brands have been mushrooming as rising incomes spur consumption. However, that also brought a myriad of new products claiming to provide unverified benefits, especially when peddled by celebrities and influencers. Stricter rules aim to curb exaggerated claims and ensure higher standards that will also benefit exports. "The cosmetic industry in India is largely under-regulated, particularly concerning product claims. Unlike in many other countries, companies here can make unsubstantiated assertions—such as promising to make a person several shades fairer or claiming to stop hair fall—that are often misleading,' said Dr Dinesh Kumar Devaraj, president, Indian Association of Dermatologists, Venereologists & Leprologists (IADVL), Tamil Nadu. 'This is where regulatory checks are critically needed.' Queries sent to the health ministry spokesperson and cosmetic manufacturers, including Hindustan Unilever Ltd, on Friday remained unanswered. Cosmetics in India are regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The Central Drugs Standard Control Organization (CDSCO) is the main regulatory body responsible for implementing the rules. 'Lots of clerical and administrative corrections have been made in cosmetics rules,' the first official quoted earlier said. 'These comprehensive measures signal a serious commitment by the government to prioritize consumer safety and bring greater transparency to India's cosmetics industry.' Manufacturers will now have to keep detailed records of all raw materials and manufactured batches for three years or six months after the batch expires, whichever is later. This improved record-keeping will significantly enhance the traceability of products in case of a safety concern. The new regulations require that labels on cosmetics to be exported meet the legal standards of the destination country. A cornerstone of the new policy is the Central Cosmetics Laboratory to test samples. It will also be an appellate laboratory, ensuring a centralized and rigorous approach to product quality. The rules, for the first time, empower the State Licensing Authority to suspend or cancel a license if a company fails to comply with any of its conditions or with any provision of the Act or the rules. This order will be issued in writing after giving the licencee an opportunity to show cause and be heard. However, a manufacturer whose licence is suspended or cancelled has the right to appeal the decision to the state government within 90 days, ensuring due process is followed. The new regulations specifically define 'spurious cosmetics' under section 17D of the Act, strengthening the government's ability to crack down on counterfeit items. That provides a stronger legal basis for regulatory bodies to crack down on such items. The rules also seek to streamline international trade. 'The cosmetic is meant for export, then the label on the package or container of cosmetic shall comply with the law of the country to which the cosmetic is to be exported,' the notification said. Similarly, a specific provision has been added to allow for a code number instead of the manufacturer's name and address on the label if the importer requires it. These changes are designed to protect consumers from unsafe and counterfeit cosmetic products while strengthening the regulatory framework, the second official quoted earlier said. According to the L'Oréal India spokesperson, the updated cosmetic regulations enhance clarity and compliance, '…particularly the provision for export labelling, which significantly streamlines international trade, benefiting our exports from India to 25 countries'. Citing that 95% of its products sold in India are locally manufactured, the spokesperson said these 'progressive changes further support our 'Make in India' endeavors and our mission to provide high-quality beauty solutions both domestically and internationally'. The industry has also come under scrutiny after complaints regarding mercury-based products, Mint reported earlier. Products such as skin-lightening creams, 'anti-ageing solutions' for freckles and dark spots and certain makeup items are known to contain the toxic element. Dr. Devaraj said another concern is the misuse of steroids in cosmetics for skin brightening, which can lead to significant dermatological damage. 'As a doctor, I can easily distinguish between skin that has been brightened by such steroid use and skin that is healthy,' he said. 'The issue of wrong or non-existent labelling also needs to be addressed. Furthermore, there is a complete lack of regulation on pricing, which allows for a dramatic disparity in costs for similar products.' The validation provided by celebrities and social media influencers heavily influences consumers, especially first-time buyers, according to him. 'Given our vast population, a small fraction of buyers can generate significant profit for a company, reducing the need for repeat business,' said Dr. Devaraj. 'This trend has been amplified by the rise in online sales and paid promotions post-Covid.'
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Business Standard
26-06-2025
- Health
- Business Standard
Drugmakers may lose product licence if govt labs flag quality failures
The Health Ministry is working with states to allow immediate suspension of licences for drugs declared substandard by labs, following a key recommendation from Drugs Technical Advisory Board Rimjhim Singh New Delhi The Ministry of Health is planning strict action against pharmaceutical companies if their medicines fail quality checks. The ministry is in talks with state authorities to allow immediate suspension of licences for drugs found to be 'Not of Standard Quality' (NSQ) by government laboratories, according to a report by The Economic Times. This move aims to ensure consistent drug quality and safeguard public health, especially after several cases of substandard medicines were reported across the country. Recommendation of drug advisory board The proposed action follows the recommendation of the Drugs Technical Advisory Board (DTAB), the apex body advising the Central Drugs Standard Control Organisation (CDSCO). The board, in its recent meeting, underlined the need for quick regulatory intervention once a drug is declared NSQ, the news report said. 'The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufactures. After detailed deliberation, DTAB recommended the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented,' said the minutes of the meeting. The CDSCO is currently holding discussions with pharmaceutical industry associations, many of which have raised objections to the proposed rule. 'The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification,' said a senior government official, as quoted by The Economic Times. Pharma industry voices concerns Pharmaceutical industry representatives argue that NSQ declarations can stem from technical issues rather than deliberate negligence. The Federation of Pharma Entrepreneurs (FOPE) noted in its submission, 'NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent.' Industry groups also highlighted potential shortcomings in government laboratory practices. 'This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,' said a member of one such lobby group, as quoted by The Economic Times. Industry demands robust review and recall mechanisms Drugmakers emphasise that rather than immediately suspending licences, the focus should be on strengthening the drug recall mechanism and conducting thorough investigations before action is taken. FOPE has also called for a detailed impact assessment of the proposed rules. 'We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation,' the group said. Novo Nordisk launches Wegovy in India Danish drugmaker Novo Nordisk on Tuesday launched its weight-loss injection Wegovy in India. The once-a-week injectable, already available in the US and Europe, will reach Indian pharmacies by the end of June. Wegovy contains semaglutide, a compound that mimics a natural hormone to help control appetite, reduce cravings, and promote fullness — making it easier for users to adopt healthier habits. Approved for long-term weight management, it also lowers heart-related risks in overweight or obese individuals. Clinical trials suggest that around one in three users may lose up to 20 per cent of their body weight in just over a year, when combined with diet and exercise. In India, Wegovy is recommended for adults with a BMI of 30 or above, or over 27 with health issues like diabetes or high blood pressure. It is administered once weekly with a pre-filled pen, and the dose increases gradually. Monthly prices range from ₹17,345 to ₹26,015 depending on the dosage.
Mint
06-05-2025
- Health
- Mint
India should permit easier access to over-the-counter medicines
The liberalization of India's economy, as tracked by an embrace of free-market principles, has been rather slow in chipping away at old precepts of a nanny state. We should thus welcome the government's effort to ease the retail availability of medicines that can safely be sold over the counter (OTC): i.e., without a doctor's prescription. As reported by Mint , the Drugs Technical Advisory Board is seeking a tweak in regulations to first define OTC drugs clearly and then license a wide set of retailers to sell these. As of now, such pills can only be dispensed by chemists with qualified pharmacists behind their counters (or web interfaces). As the report indicates, the government's OTC list is likely to include regular pain-killers, anti-allergics, laxatives, cough syrups, anti-fungal products and some formulations for asthma patients. All of these—and more—are routinely used and widely bought without the explicit advice of doctors anyway. It's just that it involves hunting for chemist shops , which are far fewer than grocery stores. The convenience this proposal would assure buyers is reason enough to back it. Most legacy rules originate in a valid purpose. In general, since the misuse of drugs can be a serious health hazard, access to them cannot go unsupervised. This goes without saying. At stake here, though, are formulations that cause much less harm if used needlessly (or overdosed). Ever since the idea of wider retail supply was first proposed in 2022, it has stoutly been resisted by the All India Organization of Chemists and Druggists and Indian Pharmaceutical Association. Misuse is the key risk they have flagged. To address this worry, the list of OTC drugs must duly be vetted by medical experts and kept judiciously short. But the chemist lobby's expression of anxiety that its members may suffer a sales drop should not influence such a decision. Policy must aim for better health outcomes, after all, not protect businesses. If people at large are deemed capable of decisions on the use of OTC drugs, as they are by definition, we have no reason to restrict OTC sales only to outlets with the capacity to verify medical advice and ensure error-free delivery. Equally invalid is the objection that Indian levels of literacy are too low for our retail rules to be liberalized safely. It amounts to the state playing nanny, an approach we need to outgrow. A tight policy effort to save people from themselves by means of retail curbs could have effects that are not plainly visible. This is a market with relatively inelastic demand. As medicines are mostly bought on a need basis, offtake quantities of moderately priced pills do not vary much in line with price movements. Typically, in any market where supply cannot freely fulfil such demand, space opens up for inflated profits in various links of the supply chain. This was seen in many fields during the heyday of India's Licence Raj. In the case of medicines, a regime of price controls for some drugs has been in place to prevent exertions of monopoly power that may let unfairly large profits be made. This has been accompanied by a loose intellectual property regime that encourages rivalry in segments of off-patent drugs in heavy use. So, by and large, we have not suffered extortive pricing. Yet, price caps aren't foolproof, they don't cover all drugs, and easier retail access to OTC meds may empower the market to keep its own check on prices.
Mint
05-05-2025
- Business
- Mint
Drugmakers to face tougher quality rules: Failed a test? Re-do the exam.
New Delhi: Drugmakers failing random quality checks could potentially be deemed guilty until proven innocent under a fresh crackdown by the government on substandard, spurious and adulterated medicines. The Centre plans to suspend the product permission licence issued to a drugmaker for a particular medicine if even a single batch of that medicine is found to be substandard by any government testing laboratory, said two officials, requesting anonymity. In effect, a drugmaker will not be allowed to continue manufacturing a particular medicine after just withdrawing a failed batch, as is the current practice. India's Drugs Rules, 1945 has no provision on actions to be taken if a batch of medicines fails a quality test, apart from those specific medicines being declared as not-of-standard-quality (NSQ). A drugmaker's licence for that particular drug or product is suspended only if an investigation establishes wrongdoing on the part of the company—an often lengthy process. The Union government's proposed rule changes would also have a bearing on the global pharmaceutical industry. India, which manufactures 60,000 generic brands across 60 therapeutic categories, is the largest global supplier of generic drugs, accounting for about 20% of the global supply. Given the lacuna, state governments resort to ad-hoc actions, and in the process fail to check subpar manufacturing practices that have dented India's image as the 'world's pharmacy". States and union territories are empowered to take action against a drugmaker if a batch of medicines fails a quality check. This includes asking a manufacturer to withdraw a product or suspending the product permission licence if an investigation finds the drugmaker at fault, but these are often not implemented uniformly. 'According to the new plan, once a drug is declared NSQ, the company cannot produce another batch while the investigation is going on, the loopholes are fixed, corrective measures are taken, and regulatory authorities are satisfied with the corrective measures," said one of the officials cited above. 'This is a lengthy process and may take many years." Queries sent to the health ministry spokesperson remained unanswered. Also read | Centre orders thorough safety review of painkiller Nimesulide for adults The Union health ministry will shortly issue a draft notification based on recommendations from India's top drug panel, the Drugs Technical Advisory Board (DTAB), according to the second of the two officials mentioned above. Accordingly, the government plans to amend the Drugs Rules to allow for the immediate suspension of the licence for a medicine that has failed a quality check until the company submits a corrective action and preventive action (CAPA) plan, which has to be approved. All states and union territories will have to follow the new rules, the official said. The suspension on the product licence will only be revoked after a root cause analysis and implementation of corrective measures, according to DTAB's minutes of a meeting on the issue, which Mint has reviewed. 'This is a very important decision taken by the top drug panel," said the first official quoted above. 'Right now, the provision is whenever any drug is identified as NSQ, the licensing authority tells the company that this particular drug batch has failed the quality test, and you (company) withdraw the product from the market. And later an investigation is carried out. In such a case, the manufacturer can go on producing the subsequent batches of the drug. So, there is no restriction on the manufacturer," the official said. Also read | IPC raises concern over five lifesaving drugs for causing adverse reaction The government's plan has come as a shocker to India's $50 billion pharmaceutical industry, which insists that a particular batch of medicines could fail a random test for reasons other than poor quality. 'We respect the DTAB's decision as we understand that they are trying to do something to control NSQ. However, we don't think it is a very good idea to suspend the product permission license as soon as a drug is declared NSQ. There needs to be a thorough investigation before that)," said Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association, which represents more than 1,000 pharmaceutical companies. 'A product can fail due to many reasons such as analytical error, labelling issue, storage or manufacturers issues, or it could be spurious (and may not be manufactured by the original company," Shah said. 'The basic principle to suspend the product permission license is ok until CAPA is done, and we are not against that. However, it should be done with proper checks and balances, and the root cause has to be identified." The government's plan, however, assumes significance considering that 2,988 drug samples were declared to be 'not of standard quality' in 2023-24, and 282 drug samples were found to be spurious or adulterated, according to a response by the government in Parliament. 'Suspending the product permission license is the right thing to do," said Dr. R.V. Ashokan, past president of the Indian Medical Association. 'If a manufacturer cannot ensure the quality of the drug, then they should not do business in this area. Already there is no control on spurious drugs and regulation has failed to stop that. At least in the case of NSQ, the regulatory authorities have the licence with them to control manufacturers." Also read | For small drugmakers playing fast and loose with quality, trouble is on way
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Business Standard
01-05-2025
- Health
- Business Standard
Ban on popular heartburn drug Ranitidine deferred amid cancer concerns
If you've ever reached for a tablet after a spicy meal, chances are it was Ranitidine—commonly sold under brand names like Zinetac, Rantac, or Aciloc. For years, it has been the go-to remedy for acid reflux and heartburn. But lately, the drug has been in the news for all the wrong reasons. Some studies have found that Ranitidine can contain N-nitrosodimethylamine (NDMA), a chemical possibly linked to cancer. Despite global apprehension regarding the potential carcinogenic impurity, Indian authorities have opted not to ban the widely used heartburn medication. Countries are banning Ranitidine. Why not India? Ranitidine has been under scrutiny since 2019, when studies indicated that it could degrade over time to form NDMA, a probable human carcinogen. This led to its withdrawal in several countries, including the United States, European Union, and Australia. Recently in India, an expert panel recommended the drug's suspension, but the Drug Advisory Committee decided instead to form a larger committee to evaluate all aspects. Following a meeting last week, the Drugs Technical Advisory Board (DTAB) also advised the Indian Council of Medical Research (ICMR) to conduct a study to assess Ranitidine's safety, The Economic Times reported. What is Ranitidine, and why was it so widely used? Developed in 1981 by Glaxo Holdings Ltd (now part of GlaxoSmithKline or GSK PLC), Ranitidine became one of the most widely used medications for managing stomach acid. Marketed under popular brands like Rantac, Zinetac, and Aciloc, it was readily available over the counter. The drug was widely used to relieve indigestion and heartburn, and to treat conditions such as gastroesophageal reflux disease (GERD) and ulcers. Despite being banned in several countries, Ranitidine remained a staple in Indian households for decades. Half of Ranitidine samples exceed global NDMA safety limits The Central Drugs Standard Control Organisation (CDSCO) has taken measures to ensure patient safety. Last year, it formed a committee to examine NDMA-related safety concerns. Ranitidine samples were sent to a government lab for analysis, and the results raised concern. Out of 42 samples tested at the Central Drug Laboratory in Kolkata, 21 were found to have NDMA levels above 0.32 parts per million (ppm)—exceeding the internationally accepted safety limit. Long-term exposure to such levels has been linked to increased cancer risk. The controversy has sparked significant legal action globally. In the US, pharmaceutical companies such as GSK have faced numerous lawsuits alleging that Ranitidine caused cancer. So, should you still be taking it? Here's the honest answer: Talk to your doctor. If you're using Ranitidine occasionally and haven't experienced any issues, your doctor may still consider it acceptable. But if you're concerned, there are other alternatives that do not carry the same risk. For now, Ranitidine remains legally available in India, though regulators are keeping it under close observation.
