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Hindustan Times
05-05-2025
- Health
- Hindustan Times
Non-prescription drugs to be sold at neighbourhood grocery stores soon: Report
People would not have to take a trip to a medical store anymore to get non-prescription medicines such as cough syrups, pain relievers and anti-fungal cream as these drugs may soon be available at neighbourhood grocery stores, reported Mint. In a move that aims to make non-prescription drugs more accessible for people, the Drugs Technical Advisory Board (DTAB) decided in April that such drugs can be sold at grocery stores, the Mint report said citing three people familiar with the matter. However, no official notification has been issued yet. There are several drugs that can be bought in India without a signed prescription from a doctor, such as painkillers, cough syrups, anti-allergics, laxatives and anti-fungal products. These are also called over-the-counter (OTC) drugs. While the retail store owners won't need to hire a pharmacist for the sale of these drugs, they will have to obtain a licence, said the report. According to one of three sources, the government has been working on making this happen for quite some time now and a final decision is not far away. 'The government is finalizing the list of OTC drugs and products which can be sold at retail shops. The government has been working on this for a long time, and a final decision is to be taken shortly," the report quoted the person as saying, who also attended the DTAB meeting. The second official familiar with the matter told Mint that the government is working on formulating new regulations that will define what these OTC drugs are. 'Right now, OTC drugs are not defined or covered under the Drugs Rule, 1945. Once these regulations are in place, the public will be aware of what OTC drugs are, and what types of drugs can be purchased without a prescription…The move is aimed at ensuring accessibility and availability of OTC drugs to the people even in the interiors of the villages and remote areas," the official said. While the move may prove beneficial for people for cutting down their trip to a medical store to get a non-prescription drug, it puts medical stores and chemists at a risk of loss of sales. The All India Organization of Chemists and Druggists (AIOCD) is not in favour of the move and has been opposing it. Expressing concern over how the move will unfold and affect chemists, AIOCD's general secretary Rajiv Singhal said, 'Where will we go? This will put the growth of pharmacists at risk.' He said that letting retail stores sell OTC drugs can lead to misuse and had urged the government to consult and be transparent with chemists before making any decision. "We are going to submit our representation to the government to seek a transparent and balanced approach in finalizing the sale of OTC drugs at retail level and involve stakeholders like the Indian Medical Association, doctors and Indian Pharmaceutical Association (IPA) before finalizing the change," he said. According to the third person familiar with the matter, a list of OTC drugs has already been prepared by the sub-committee and is on the way of getting a final nod after the government re-issues a 'draft notification on OTC drugs regulation' and takes stakeholders' comments.
Mint
05-05-2025
- Health
- Mint
You may get to buy non-prescription drugs at a friendly neighbourhood store
Cough lozenges, pain relievers and anti-fungal creams may soon be available at a neighbourhood grocery store near you, in a move that promises easy access to common medicines but raises concerns of potential misuse. The Drugs Technical Advisory Board (DTAB) decided last month that several medicines that do not need a prescription may be sold at retail outlets, three people aware of the matter said. These include analgesics, anti-allergics, antihistamines, cough syrups, laxatives, antifungal products, and certain asthma drugs. Though retail stores won't need a pharmacist like regular chemists, they will need to secure a licence for selling these medicines, also called over-the-counter (OTC) drugs. 'The government is finalizing the list of OTC drugs and products which can be sold at retail shops. The government has been working on this for a long time, and a final decision is to be taken shortly," said one of the three people cited above, who attended the DTAB meeting. The move spells relief for consumers who can pick up these medicines from just about anywhere, but also casts a pall of gloom over tens of thousands of chemists staring at loss of sales. Queries emailed to the Union health ministry remained unanswered. New regulations will define OTC drugs and formulate a separate schedule for them, the second official said. "Right now, OTC drugs are not defined or covered under the Drugs Rule, 1945. Once these regulations are in place, the public will be aware of what OTC drugs are, and what types of drugs can be purchased without a prescription, the official said. 'The move is aimed at ensuring accessibility and availability of OTC drugs to the people even in the interiors of the villages and remote areas," the official added. Also read | Healthify shifts gears to incorporate weight-loss drugs, cash in on anti-obesity boom The All India Organization of Chemists and Druggists (AIOCD), which represents 1.24 million members and the Indian Pharmaceutical Association representing 13,000 members, have protested against the plan ever since the government floated the idea of selling OTC drugs at retail shops years ago. 'Where will we go? This will put the growth of pharmacists at risk," said Rajiv Singhal, general secretary of AIOCD. "We are going to submit our representation to the government to seek a transparent and balanced approach in finalizing the sale of OTC drugs at retail level and involve stakeholders like the Indian Medical Association, doctors and Indian Pharmaceutical Association (IPA) before finalizing the change," Singhal said, adding OTC drugs at retail stores may also lead to misuse. The government must share the list of retail OTC drugs with chemists so they can provide feedback on the pros and cons of the decision, he added. 'The sub-committee has prepared a list of OTC drug items. The government will now re-issue a draft notification on OTC drugs regulation, take stakeholders' comments before giving the final nod," the third official added. Read this | Demand for weight loss drugs is growing. Can wellness companies keep up? In 2022, the Centre had issued a draft notification permitting the sale of 16 specific OTC drugs without a prescription by retailers with a valid licence, a move that chemists' bodies have opposed since then. In 2024 , the DTAB formed a sub-committee to develop a detailed mechanism for the drugs to be considered as OTC. DTAB agreed with the sub-committee's recommendations. 'Legal provisions to be enabled under Drugs Rules, 1945 along with manner of submitting application, prescribe the licensing requirements for the sale of OTC drugs which does not require the supervision of registered pharmacist, requirements for considering a drug as an OTC, labelling requirements, etc. and incorporation of a separate schedule," the meeting's minutes showed. Experts agreed on the need for OTC drug regulations. "These drugs are generally regarded as safe within their therapeutic dosage and therefore, 'responsible people' can use them," said Dr. Y.K. Gupta, who has headed the All India Institute of Medical Sciences' pharmacology department. However, he noted that many Indians may not be educated enough to choose these medicines wisely, and hence, there is a possibility of abuse or overuse. The decision will make OTC drugs widely available to the public, Gupta said, while pointing to the easy availability of even prescription drugs and antibiotics over the counter. "We have to have a balanced approach in terms of accessibility, availability and avoiding inconvenience," said Gupta, who is also the national scientific coordinator of India's pharmacovigilance programme to ensure drug safety. And this | Govt to add 100 key drugs to widen availability of affordable medicines at Janaushadhi kendras In several countries, a large number of drugs are available off the shelf without a prescription. According to AIOCD's Singhal, India sees annual pharmaceutical sales of ₹ 1.98-2.3 trillion, out of which OTC accounts for ₹ 30,000-40,000 crore. Dr. Suranjeet Chatterjee, senior consultant of internal medicine at Apollo Hospital said the only benefit is easy availability of OTC drugs, with some downside. 'There could be a misuse of OTC drugs, and people can take the drug on their own since it does not require a doctor's prescription. The pharmacist is a qualified person, and he knows what to give to the customer. I am not totally against this decision, but at this stage, I am a bit sceptical about it. Even in the US, paracetamol and anti-allergic tablets are available at the grocery shop, but we cannot compare India with US, because people are less educated here and have no knowledge of the medicines," Dr. Chatterjee said, calling for a structured regulation. The list as submitted by the sub-committee may be considered initially, which will be dynamic and updated from time to time, the DTAB minutes said. The board also recommended a comprehensive revisit of the draft notification, for which international guidelines may also be considered and directed the sub-committee to submit a report on it. And read | IPC raises concern over five lifesaving drugs for causing adverse reaction Some of the OTC drugs that could go on retail shelves include Chlorohexidine Gluconate 0.2% (for the treatment of gingivitis), paracetamol tabs 500 mg (antipyretic), sodium chloride nasal spray, ketoconazole shampoo (anti-dandruff), lactulose solution (laxative), calamine lotion (anti-septic), xylometazoline hydrochloride (nasal decongestant) and bisacodyl tablets 5mg (laxative).
Time of India
03-05-2025
- Health
- Time of India
Panel to take a call on doorstep medicine delivery
New Delhi: The country's top advisory body on drugs has proposed to constitute a sub-committee to decide if people can continue to get medicines at their doorstep. The issue has come under scrutiny with the All-India Organisation of Chemists and Druggists (AIOCD), which represents 1.24 million chemists and distributors, demanding withdrawal of a government notification that allows doorstep delivery of drugs. The government had allowed the facility in 2020, during the Covid-19 pandemic. The matter was taken up last week by the Drugs Technical Advisory Board (DTAB). "The DTAB deliberated the issue and recommended to constitute a sub-committee to examine the matter in detail before considering withdrawal of the notification," according to the minutes of its meeting. The AIOCD had demanded withdrawal of the notification, alleging its misuse by digital platforms. After this, the health ministry asked the DTAB to give its recommendation. The March 2020 notification allowed doorstep delivery of medicines under certain conditions, such as the requirement to stamp the prescription for the sale of medicines. The AIOCD said the emergency phase of the pandemic no longer exists, therefore the notification is no longer relevant and should be revoked immediately. In a letter to union health minister JP Nadda early this year, the organisation highlighted what it termed "mounting concern regarding the continued misuse of this notification by various digital platforms", and said: "We fear with our past observations this practice of dispensing medicines without validated prescriptions appears to prioritise profit over patient welfare." The AIOCD said it failed to understand why the government was extending "undue privileges" to such platforms. "This leniency has sown the seeds of alarming possibilities, multiple dispensations on a single prescription, escalating the dependency and an upsurge in self-medication which can inflict irreversible harm," it said. India's online pharmacies currently operate in a regulatory grey area. Retail chemists' organisations have been protesting the sale of medicines through e-pharmacies since they are not regulated. The government has proposed legislation on multiple occasions but has yet to frame one. In 2018, the health ministry released a draft notification regulating e-pharmacies, proposing to ban the selling of medicines without registration. The draft also proposed a ban on the sale of narcotics, psychotropic drugs and tranquillisers by online pharmacies. But the rules could not be finalised.
Time of India
03-05-2025
- Health
- Time of India
Panel to take a call on doorstep medicine delivery
New Delhi: The country's top advisory body on drugs has proposed to constitute a sub-committee to decide if people can continue to get medicines at their doorstep. #Pahalgam Terrorist Attack Pakistan reopens Attari-Wagah border to allow stranded citizens in India to return Key Jammu & Kashmir reservoirs' flushing to begin soon Air India sees Pakistan airspace ban costing it $600 mn over 12 months The issue has come under scrutiny with the All-India Organisation of Chemists and Druggists (AIOCD), which represents 1.24 million chemists and distributors, demanding withdrawal of a government notification that allows doorstep delivery of drugs. The government had allowed the facility in 2020, during the Covid-19 pandemic. The matter was taken up last week by the Drugs Technical Advisory Board (DTAB). "The DTAB deliberated the issue and recommended to constitute a sub-committee to examine the matter in detail before considering withdrawal of the notification," according to the minutes of its meeting. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Wife won't let go of dog, husband finds out why and calls police - watch! Happy in Shape Undo The AIOCD had demanded withdrawal of the notification, alleging its misuse by digital platforms. After this, the health ministry asked the DTAB to give its recommendation. The March 2020 notification allowed doorstep delivery of medicines under certain conditions, such as the requirement to stamp the prescription for the sale of medicines. Live Events The AIOCD said the emergency phase of the pandemic no longer exists, therefore the notification is no longer relevant and should be revoked immediately. In a letter to union health minister JP Nadda early this year, the organisation highlighted what it termed "mounting concern regarding the continued misuse of this notification by various digital platforms", and said: "We fear with our past observations this practice of dispensing medicines without validated prescriptions appears to prioritise profit over patient welfare." The AIOCD said it failed to understand why the government was extending "undue privileges" to such platforms. "This leniency has sown the seeds of alarming possibilities, multiple dispensations on a single prescription, escalating the dependency and an upsurge in self-medication which can inflict irreversible harm," it said. India's online pharmacies currently operate in a regulatory grey area. Retail chemists' organisations have been protesting the sale of medicines through e-pharmacies since they are not regulated. The government has proposed legislation on multiple occasions but has yet to frame one. In 2018, the health ministry released a draft notification regulating e-pharmacies, proposing to ban the selling of medicines without registration. The draft also proposed a ban on the sale of narcotics, psychotropic drugs and tranquillisers by online pharmacies. But the rules could not be finalised.
News18
02-05-2025
- Health
- News18
'Nimesulide Is Safe': Dr Reddy's Defends Painkiller As Ban Looms On Doses Above 100 Mg
Last Updated: The company told News18 that the robust research and clinical trials have consistently established the safety and efficacy of Nimesulide when used as prescribed. Hyderabad-based pharmaceutical giant Dr Reddy's Laboratories is defending the use of the painkiller Nimesulide, even as the drug comes under regulatory scrutiny over safety concerns, with a possible ban looming on doses above 100 mg. In January this year, the company submitted a detailed presentation, seen by News18, to the apex drug regulatory body along with top officials from the Indian Council of Medical Research (ICMR) and the Directorate General of Health Services (DGHS), arguing against the idea of banning Nimesulide. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) which has been widely used in India for its analgesic and antipyretic properties. However, safety concerns emerged over its adverse effects, particularly side effects on the liver, leading to regulatory scrutiny and actions across the globe. According to the report prepared by the country's top medical research body, the Indian Council of Medical Research (ICMR) – following a request from the Drugs Technical Advisory Board (DTAB) – all formulations of the popular painkiller Nimesulide above 100 milligrams should be banned, and a 'black box" warning should be made mandatory on all products containing the drug. Highlighting the poor safety profile, an 11-page report by ICMR suggests that the drug should be reserved only as a second-line treatment and used only after all first-line options have been tried and found ineffective. While agreeing with many of ICMR's findings, the apex panel of experts recommended that all oral formulations of Nimesulide above 100 mg in 'immediate release dosage form" should be prohibited. They also advised restricting its use among vulnerable groups such as children under 12, adults over 60, pregnant and lactating women, and people with kidney or liver diseases. However, the recommendations are yet to be approved by the Drug Controller General of India (DCGI). Why does Dr Reddy's want to protect Nimesulide? According to data from the research firm Pharmarack, Dr Reddy's is the largest seller of branded Nimesulide under the name 'Nise', with a moving annual turnover (MAT) of Rs 94 crore as of March 2025, followed by Mankind Pharma, Maneesh Pharmaceuticals, and IPCA Labs. Responding to News18's query on the latest DTAB recommendations, Dr Reddy's said: 'We acknowledge and appreciate the Drugs Technical Advisory Board's (DTAB) directives to the Indian Council of Medical Research (ICMR) for conducting a systemic review of Nimesulide's use across various age groups." It further added that 'the DTAB's minutes also recognise Nimesulide as an effective medication, highlighting its significance and necessity." The company also clarified: '…our company does not manufacture or distribute Nimesulide in doses exceeding 100 mg. The prescribing information specifies that Nimesulide is indicated for short-term treatment in approved indications and not exceeding more than 10 days." Additionally, it said its prescribing information states that 'Nimesulide is not recommended for use in pregnant or lactating women and patients with renal or hepatic impairments." How is Dr Reddy's trying to convince ICMR and experts that Nimesulide is non-fatal? In January, Dr Reddy's Laboratories wrote a detailed letter to the Joint Drug Controller (FDA Bhawan), Rajiv Bahl (Director General, ICMR), and Dr Atul Goel (Directorate General of Health Services) — after ICMR was tasked with conducting a safety assessment of the drug. The company cited several judicial proceedings in multiple high courts where no ban was imposed on Nimesulide, relying on earlier DTAB submissions affirming the drug's safety. 'We wish to highlight that the subject matter of the safety of Nimesulide came before various courts such as the High Court of Judicature at Delhi and Madras in 2004, and again in 2008, and most recently before the Delhi High Court in 2023." The company noted that in these proceedings, the DTAB stated: 'After detailed deliberations, members opined that, having considered the issues raised by the petitioner and the overall data on this drug, there is no ground for banning Nimesulide for adult or pediatric use. The drug is considered to be as safe or unsafe as any other commonly used NSAID." 'It was on the basis of this report that the High Courts concluded that no ban on Nimesulide for human use is necessary," the company said. The company also provided additional studies and findings from independent bodies supporting the drug's safety. It referred to a 2004 PIL in which DTAB had again found Nimesulide safe. 'DTAB, in its report, considered opinions from bodies including the Indian Academy of Pediatrics (IAP), the Indian Medical Association (IMA), AIIMS, and other experts," the letter said. '…No causal relationship with serious liver toxicity or Reye's Syndrome, as alleged side effects of the drug, was reported by any of these experts…," it said. It further added that '…the High Court concluded that the allegations are not worth further consideration." The company included a subhead titled 'Data indicating safety in the human adult population." 'As already indicated by DTAB and the Government of India before various High Courts, and also by leading medical associations, we submit that the product remains safe for adult use. We also present safety data from India and international agencies, including the WHO, that establish the safety of Nimesulide," the letter said. The letter, written by Sandeep Khandelwal, Head – India Sub-Continent, Dr. Reddy's Laboratories, urged top experts to consider 'the above information in your deliberations on the safety of Nimesulide for use in the adult population." Khandelwal further stated, 'We submit that the data enclosed clearly establish Nimesulide's safety as one of the highest in its category. This is why DTAB and other independent bodies have consistently found no significant adverse effects and reported high acceptance among physicians and patients." Overall, Dr. Reddy's sought to reassure the latest DTAB panel by referencing past DTAB evaluations that found Nimesulide to be safe. 'We trust that our effort to provide a historical summary of DTAB's evaluations — supported by associations like the IMA and other experts — will serve as sufficient evidence of this drug's safety and efficacy," the letter concluded, adding, 'Should your findings require any collaboration or further material in support of these submissions, we remain at your disposal and will be glad to furnish the requisite information." Globally, the European Medicines Agency (EMA) restricted the use of Nimesulide in 2002 to adults only, and since then, many countries, including the United Kingdom, the United States, Canada, Australia, Singapore, and Japan, have imposed bans or strict usage guidelines for both human and veterinary applications. It is only in India and Pakistan that the drug is available for consumption by the elderly and adults. Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : Dr Reddy's Laboratories Painkillers Location : New Delhi, India, India First Published: May 02, 2025, 11:34 IST News india 'Nimesulide Is Safe': Dr Reddy's Defends Painkiller As Ban Looms On Doses Above 100 Mg
