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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
22-04-2025
- Health
- News18
India May Ban Popular Antacid Ranitidine After Years Of Deliberation On Cancer Risks, Expert Panel Files Report
Ranitidine reduces the amount of acid in the stomach and relieves acid-related indigestion and heartburn. It is sold under popular brand names like Aciloc, Rantac and Zinetac After years of deliberation, India is likely to ban the widely used over-the-counter (OTC) antacid Ranitidine due to cancer-causing concerns, News18 has learnt. The ban has been recommended by an expert panel, and its report has been submitted to the apex body, Drug Technical Advisory Board (DTAB), which advises the Drug Controller General of India on regulatory actions. According to the latest agenda document for the meeting of the Drug Technical Advisory Board, seen by News18, DTAB is slated to discuss this report recommending the 'suspension of the drug ranitidine for manufacture, sale and distribution in the country". Among several observations, the report noted that of the 42 Ranitidine samples tested at the Central Drug Laboratory in Kolkata, 21 were found to contain NDMA impurities exceeding 0.32 PPM. This level surpasses the globally acceptable limit for the impurity, which is linked to an increased risk of cancer over a lifetime. The drug Ranitidine reduces the amount of acid made in the stomach, and it relieves acid-related indigestion and heartburn. It is sold under popular brand names such as Aciloc, Rantac, and Zinetac. However, this category of medicines has been under scrutiny since 2019, when the US Food and Drug Administration alerted about a drug that contains low levels of cancer-causing substances. The US FDA had suggested that some Ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. 'NDMA is classified as a probable human carcinogen—a substance that could cause cancer—based on results from laboratory tests," the FDA had said earlier. India had been deliberating over the use of this category of drugs since then. Meanwhile, in 2022, the central government dropped the drug from the national list of essential medicines (NLEM) due to cancer-causing concerns. What does the latest report say? The agenda document, seen by News18, lists 'Consideration of the proposal to examine the safety related to Ranitidine drug due to the presence of NDMA impurity". It said that the 'safety issue related to the Ranitidine drug due to the presence of NDMA impurity has been under consideration for quite some time, and CDSCO has taken various measures from time to time". It recalls that 'Ranitidine was in the National List of Essential Medicines (NLEM), 2015. However, it was deleted and does not appear in NLEM, 2022". To have a broad-based decision in the matter, an expert committee was constituted in 2024. Now, the subcommittee has submitted its report for further deliberation at the DTAB meeting. 'After detailed deliberation, the committee recommended for suspension of the drug Ranitidine for manufacture, sale and distribution in the country," said the document while attaching the report submitted by the panel. However, the subcommittee and DTAB can only deliberate on the issue and submit their recommendation on the matter to the apex authority, the Drug Controller General of India (DCGI). The final move kicks in only when DCGI approves DTAB's recommendations. Report submitted by panel to DTAB The panel—led by Dr Vineet Ahuja, Department of Gastroenterology at All India Institute of Medical Sciences (AIIMS), New Delhi—noted that 'international regulatory agencies and available literature mention that ranitidine may contain a nitrosamine impurity called NDMA at low levels". From the presentation delivered by the members of the committee, the panel found that 'NDMA and NDEA belong to the 'cohort of concern', which is a group of highly potent mutagenic carcinogens that have been classified by the WHO's International Agency for Research on Cancer as probably human carcinogens". 'Various studies conducted revealed that the presence of NDMA may result from a slow degradation of the ranitidine molecule through the intermolecular reaction of ranitidine hydrochloride without the involvement of impurities," it said. The report also noted that 'Ranitidine hydrochloride and its inherent Impurities A, C, D, E, H, and NDMA at different rates in ranitidine". The subcommittee observed that the internationally acceptable intake limit of NDMA is 96 ng per day or 0.32 ppm of NDMA in the active ingredient. However, 'Total 42 samples of Ranitidine API were tested in CDL, Kolkata, out of which 21 samples were found to have NDMA impurity more than 0.32 PPM (ranged from 0.336 PPM – 5.19 PPM)." 'The acceptable intake (AI) limit for nitrosamines in drugs is generally set to correspond to an increased cancer risk of one additional case in 100,000 subjects over a lifetime of 70 years," the report said. The subcommittee has reviewed the decisions of different stringent regulatory authorities on the drug Ranitidine, including the US, Japan, Europe, Australia, and Canada, among others. 'The committee concluded that the drug Ranitidine is withdrawn/suspended by regulatory agencies such as USFDA, EMA, TGA and is no longer being distributed in the USA, EU, Australia and Japan," said the report. The panel also observed that other standard-of-care drugs to treat heartburn by reducing stomach acid and preventing gastric reflux and ulcers are already available in the country. top videos View all '…after evaluating the global regulatory status of the drug ranitidine and observation that global regulatory authorities have discontinued the drug ranitidine due to concerns over NDMA contamination and as the chemical structure of ranitidine predisposes the risk of nitrosamine impurity and as some of the samples tested were within NDMA acceptable level whereas some sample were out of the limit," said the report. The panel, as a precautionary measure, recommends 'suspension of drug Ranitidine for manufacture, sale and distribution in the country. However, the committee opined that people taking ranitidine should consult their healthcare professional for other treatment options". tags : drug medicine Location : New Delhi, India, India First Published: April 22, 2025, 19:15 IST News india India May Ban Popular Antacid Ranitidine After Years Of Deliberation On Cancer Risks, Expert Panel Files Report
