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Time of India
07-05-2025
- Health
- Time of India
ETtech Explainer: Impact on e-pharmacies on govt's review of doorstep medicine delivery
Live Events India's top drug advisory panel – the Drug Technical Advisory Board (DTAB) – has formed a sub-committee to review a 2020 notification that allowed doorstep deliveries of medicines. This notification, which was issued during the Covid-19 pandemic, has become the latest bone of contention between offline pharmacists and digital drug delivery All India Organisation of Chemists and Druggists ( AIOCD ), representing 1.24 million chemists and distributors, has been demanding the withdrawal of the doorstep delivery of medicines, alleging its misuse by digital health ministry, in March 2020, had come out with a notification that any licenced chemist could make doorstep deliveries of medicines 'to meet the requirements of emergency arising due to pandemic Covid 19'. It also laid down certain conditions for doorstep drug deliveries, such as the availability of a prescription and the maintenance of records of such deliveries made. This move by the central government essentially allowed not only e-pharmacies but also offline chemists to make home deliveries of prescription AIOCD has said that the notification is no longer relevant and should therefore be revoked, given that the emergency phase of the pandemic no longer exists. The chemists' body approached Union health minister J P Nadda earlier this year, flagging 'mounting concern regarding the continued misuse of this notification by various digital platforms". It also said that the practice of dispensing medicines without validated prescriptions prioritised profits over patient at e-pharmacy companies anticipate little impact from the withdrawal of this notification. 'We operate with the necessary licences under the law…even prior to the notification, we operated in a fully legal and compliant manner. There is a public perception that this notification impacts our business but our lawyers have advised us that as long as we are compliant with the laws, there shouldn't be much of an impact,' a senior e-pharmacy executive told ET. However, there are growing concerns over the operations of quick commerce firms, which are either operating on a store-in-store model (by having a pharmacy operate inside their dark stores) or tying up with licensed online pharmacies.'E-pharmacies have been delivering medicines to the doorstep even before the pandemic, but the law and order were not very specific and clear. The haziness around it was removed after the March 2020 order came, which allowed them legally to do it because of the circumstances,' Gauri Chaudhari, cofounder of pharma and healthcare consultancy firm Brand burgeoning online pharmacy sector remains mired in regulatory uncertainty, operating in a legal grey zone that has sparked growing opposition from traditional chemist lobby groups have voiced strong protests against e-pharmacies, citing the lack of formal oversight, and although the government has made repeated attempts to introduce legislation to govern the digital sale of medicines, no concrete law has been enacted so in 2018, the Union health ministry issued a draft notification aimed at regulating the sector, which included a proposal to prohibit the sale of medicines without proper registration. However, the draft rules have yet to be finalised, leaving the sector in as a formal law on regulating e-pharmacy operations is yet to be finalised, companies are increasingly moving towards rapid delivery of medicines. ET had reported in March that rapid delivery of prescription medicines is emerging as the next battleground in India's quick commerce industry, with established firms such as Tata Digital's 1mg and Apollo 24/7, and startups vying for a share of this fast-growing commerce firms Swiggy Instamart and Flipkart Minutes have tied up with Pharmeasy to offer 10-minute medicine deliveries, and Zepto is setting up this service in its own insiders say that despite surging consumer demand for quick medicine delivery, online pharmacies may face significant hurdles that could stall their aggressive growth ambitions. The biggest challenge lies in meeting shorter delivery timelines while complying with complex approach being taken by companies, including Tata 1mg and startups such as Bengaluru-based Plazza, is integrating brick-and-mortar pharmacies into the digital supply chain, which allows them to reduce delivery timelines by fulfilling orders from neighbourhood locations instead of centralised hybrid model, however, comes at a steep cost of setting up physical outlets – each of which requires its own licences to retail drugs while complying with strict storage and handling norms under the Drugs and Cosmetics Act.
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Business Standard
23-04-2025
- Health
- Business Standard
Is your heartburn pill safe? Panel recommends banning ranitidine in India
The government may consider a nationwide ban on the widely used antacid ranitidine after an expert committee reportedly submitted a detailed report highlighting its potential cancer risks. According to a report by News18, which claims to have accessed the confidential document, the expert panel's findings may finally lead to regulatory action on a drug that has been under scrutiny since 2019. Panel recommends ranitidine suspension over NDMA cancer risk The report by the expert panel has been submitted to the apex body, the Drug Technical Advisory Board (DTAB), which advises the Drug Controller General of India on regulatory actions. According to the latest agenda document for the DTAB meeting, accessed by News18, the board is set to deliberate on a recommendation to suspend the manufacture, sale, and distribution of ranitidine in India. Half of ranitidine samples exceed global NDMA safety limits The report noted that, of the 42 samples of ranitidine tested at the Central Drug Laboratory in Kolkata, 21 were found to contain levels of N-nitrosodimethylamine (NDMA) impurities exceeding 0.32 parts per million. This surpasses the globally accepted threshold for the impurity, which is associated with a heightened risk of cancer upon prolonged exposure. What is ranitidine, and why was it so widely used? Ranitidine, first developed in 1981 in Europe by Glaxo Holdings Ltd, now part of GlaxoSmithKline (GSK) PLC, is sold over the counter under popular brand names such as Rantac, Zinetac, and Aciloc. It works by reducing stomach acid and is commonly used to relieve indigestion, heartburn, and treat gastroesophageal reflux disease (GERD) and ulcers of the stomach and intestines. Though banned in the United States, Europe, Australia, and several other countries, it has been a staple in Indian households for decades. Concerns over the drug arose after several international regulatory bodies—including the US Food and Drug Administration, European Medicines Agency, and Australia's Therapeutic Goods Administration—removed ranitidine from their markets over unacceptable levels of NDMA. In December 2024, the government informed the Rajya Sabha that the Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory body, had taken steps to address safety concerns surrounding NDMA in ranitidine. Ranitidine removed from essential medicines list in 2022 While India has thus far refrained from banning ranitidine, it was removed from the National List of Essential Medicines (NLEM) in 2022, and multiple safety advisories were issued. The News18 report now suggests that a formal ban may soon follow.
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
