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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.
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Business Standard
25-04-2025
- Health
- Business Standard
Booster dose: India inches closer to regulatory framework for OTC drugs
India may soon have a streamlined regulatory framework around over-the-counter (OTC) drugs as the apex advisory board of drugs has approved the recommendations made by a special OTC sub-committee constituted by the drug regulator. Around 27-30 drugs, primarily analgesics, topical ointments for pain, cough-and-cold medications, etc., could be part of India's first comprehensive OTC drugs list, which would also enable pharma companies to advertise around these brands to create awareness. More drugs can be added to the list in future. Sources in the Drugs Technical Advisory Board (DTAB) told Business Standard that on Thursday they had okayed the recommendations made by the eight-member OTC sub-committee in its report. 'Now, this would be taken up by the health ministry, and once its approval comes through, the framework and guidelines can be formalised. It is a move in the right direction as India lacks a clear and formal category of OTC and a comprehensive list of OTC drugs,' said one of the sources. He further elaborated that the OTC sub-committee had studied 126 drugs and then finalised around 30 of them that fit the OTC category after research and stakeholder consultation. 'This would make sure that for day-to-day ailments, patients could buy necessary medications. The duration for which these medicines can be used has been kept low to avoid misuse. We have suggested that instead of a five-day cap on dosage distribution, it could be kept a bit flexible for certain categories. For example, if you have a sprain, you may use a topical pain-management ointment for more than five days,' the source explained. He felt that it would raise demand for OTC medicines. Dr Anupam Prakash, the OTC sub-committee chairman, said that the report is an attempt to bring in regulations for these drugs and create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from clinicians and other stakeholders. He said that around 27 drugs have been chosen to be dispensed as OTC. Last year, the Central Drugs Standard Control Organisation (CDSCO) had formed the sub-committee to draw up a framework for OTC drugs, and also create a mechanism to determine which medicines can qualify as OTC. The drugs of common use for day-to-day ailments will be available as OTC, and these medicines would have a good safety margin so as not to unduly compromise the health of the common man consuming the same. 'This includes medications that are part of the National List of Essential Medicines (NLEM) and are approved for distribution by the CDSCO,' Prakash added. Calling it the first attempt at bringing a separate rule for regularising OTC drugs since Independence, Prakash said that the sub-committee has recommended a proposal to accept applications for adding other drugs in the OTC list in the future. 'We have proposed that a protocol be enshrined for revision in the list if any stakeholder wants to apply, fulfilling certain guidelines,' he added. Experts have cautioned against self-medication across categories, and, therefore, having a clear list of OTC medications will help reduce misuse. Dr Tushar Tayal, consultant, internal medicine, at CK Birla Hospital, Gurugram, said that self-medication with drugs such as antibiotics, painkillers, and sedatives, commonly bought from chemists without a prescription, can lead to significant health risks and side effects. 'Antibiotics like amoxicillin, ciprofloxacin, and azithromycin are frequently used without medical guidance. Improper or incomplete use of antibiotics can lead to antibiotic resistance, making future infections harder to treat and spreading resistant bacteria in the community,' he added. Tayal said painkillers, especially Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen, diclofenac, and naproxen are also commonly misused, which can irritate the stomach lining, leading to ulcers and bleeding, and in some cases cause kidney damage or raise the risk of heart attack and stroke. Some analysts said that with a clear list of OTC drugs and an attempt to regulate this space, there can be some impact on volumes. Nirali Shah, analyst with Ashika group, said that a clampdown on OTC drug sales could dent Indian Pharma Market (IPM) volume growth, especially in the acute therapy segment where self-medication is rampant in analgesics, antipyretics, and common cold medicines. 'IPM value may hold up in the short term due to price stickiness and a higher share of chronic therapies, but overall market growth could soften if consumer access is restricted or redirected,' she said. Most analysts don't see much of an impact on volumes as such. Sheetal Sapale, vice-president, commercial, Pharmarack, said that it is difficult to draw up the exact size of OTC medicines as there is no clear list. Typically, drugs like analgesics, antiseptics, contraceptives, some vitamins, laxatives, cough syrups, etc. are dispensed as OTC. Sapale does not think volumes would be impacted once OTC regulations come into place.
Time of India
24-04-2025
- Health
- Time of India
Plug Spill Over the Counter, says Drugs Panel
Live Events India's top advisory board on drugs is considering a plan to rein in the sale of commonly used over-the-counter (OTC) medications to prevent misuse and ensure patient safety, said people with knowledge of the matter. Under the proposal, only 27 drugs can be sold without a doctor's prescription, that too with curbs on dosage and the list are antipyretics, painkillers, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone (anti-emetic), iron and folic acid tablets, besides SOS drugs that are currently being dispensed without the need for a prescription have been excluded, as the sub-committee is of the view that these should only be sold on doctor's approval. The Drugs Technical Advisory Board is expected to meet this week to decide on the Central Drugs Standard Control Organisation, the country's regulatory authority, last year formed an eight-member sub-committee to draw up a framework for OTC drugs. It was asked to create a mechanism for determining which medications would qualify as OTC drugs, incorporating suggestions from Anupam Prakash, the OTC sub-committee chairman, confirmed that the report had been submitted. 'The aim was to increase the accessibility of commonly used medicines and at the same time ensure safety of the patient,' he said.'All SOS medicines have been included on the list. We have dropped many medicines which are available at pharmacists and should only be dispensed with prescriptions,' said those on the OTC list, the sub-committee has recommended 'smaller' pack sizes appropriate for the duration of the treatment to promote safe use, especially for medications with the potential risk of misuse or overdosing.'One of the recommendations is that the pack size of the drug should not exceed the maximum dose recommended for five days. The pack size (2-3-5) has been recommended, depending on the toxicity of the drug,' said one of the persons other words, the shortlisted drugs can be sold over the counter without the prescription of a registered medical practitioner only if the maximum duration of treatment or use does not exceed five term 'over the counter' is not defined in India's Drugs and Cosmetics Act, 1945, unlike in the US, the UK and elsewhere, which have well-defined guidelines on drugs that can be sold without a prescription.
