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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.
News18
24-04-2025
- Health
- News18
Paracetamol, Ibuprofen May Soon Be Available At General Stores As India Reviews First List Of OTC Drugs
Last Updated: A committee has proposed that India needs to develop legal provisions, eligibility for considering drug as OTC and special labelling similar to those for prescription medicines A total of 27 prescription-only medicines, including levocetrizine, ibuprofen and paracetamol will soon be sold at medical and general stores as over-the-counter (OTC) drugs, News18 has learnt. The list of 27 drugs includes the names of generic formulations and the strength of doses allowed to be sold without a prescription. Currently, India lacks a comprehensive set of regulations governing the distribution, marketing, and consumption of OTC drugs. In May, drug regulator Central Drugs Standard Control Organisation (CDSCO) constituted a sub-committee to examine matters regarding the amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC), in line with a recommendation of the Drugs Technical Advisory Board (DTAB) meeting. Now, the panel has submitted the report, and DTAB will deliberate to move on moving forward. 'The subcommittee has finely balanced and submitted the report containing almost 27 generic names of formulations for the top therapeutic segment. These formulations are top-selling and best in the safety profile of that category. For instance, Levocetirizine is best to treat allergies, ibuprofen is best for painkillers and paracetamol for anti-pyretic use," a senior official at the Ministry of Health and Family Welfare, privy to the development, told News18. The sub-panel has also mentioned the strength of the medicines which should be available in the OTC category. 'It would be damaging if people end up popping painkiller ibuprofen in higher doses. Hence, the idea is to keep the moderate or mild dose available without prescription." 'Legal provisions to be enabled under Drugs Rules, 1945 along with the manner of submitting application, requirements for considering a drug as an OTC, Labelling requirements, etc and incorporation of a separate Schedule as enumerated under section 7 of the report," said the government document containing agenda for discussion on upcoming DTAB meeting. The DTAB meeting is expected to convene in April. However, the final decision may take several meetings as the central government needs to design a full plan before it decides to shift prescription medicines into the OTC category. The sub-committee was headed by Dr Anupam Prakash, Director and Professor of Medicine, Lady Hardinge Medical College, Delhi. The panel has other members including as Dr Umesh D Suranagi from Director General of Health Services (DGHS), Paediatrician Dr Ratan Kumar Gupta from Vardhman Mahavir Medical College & Safdarjung Hospital and Dr Bikash Medhi, Department of Pharmacology, Post Graduate Institute of Medical Education & Research (PGIMER).
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.
Economic Times
24-04-2025
- Health
- Economic Times
Drugs panel considering proposal to rein in sale of OTC medicines to prevent misuse
India's drug advisory board is considering restricting over-the-counter medication sales to prevent misuse and ensure patient safety. The proposal limits OTC sales to 27 drugs, including antipyretics and painkillers, with dosage and quantity restrictions. The board aims to increase accessibility while ensuring patient safety by excluding several currently available drugs and recommending smaller pack sizes for safe use. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads New Delhi: 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.
Time of India
24-04-2025
- Health
- Time of India
Drugs panel considering proposal to rein in sale of OTC medicines to prevent misuse
New Delhi: 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 amounts. On the list are antipyretics, painkillers, antacids, cough syrups, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone (anti-emetic), iron and folic acid tablets, besides SOS medication. Several 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 recommendation. 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 clinicians. Live Events Dr 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 Prakash. For 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 cited. In 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 days. The 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.
