Latest news with #DTAB
Economic Times
30-07-2025
- Health
- Economic Times
Monitor presence of potentially carcinogenic chemical in Ranitidine: DCGI to drug controllers
New Delhi: Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine. Ranitidine is used to reduce the amount of acid the stomach makes and also in the treatment of acid reflux and stomach or intestinal ulcers among issue related to safety of Ranitidine drug due to presence of N-Nitrosodimethylamine (NDMA) impurity has been under consideration for quite some time now and various measures have been taken from time to time, the Drugs Controller General of India (DCGI) said in a communication on July 24. An expert-committee was constituted in December last year and the report of the expert committee was placed before the 92nd Drugs Technical Advisory Board (DTAB) meeting in April this year, the communication, which also had minutes of the DTAB meeting as enclosures, said. The communication said DTAB, after detailed deliberation, recommended that a larger committee is required to be constituted which will look into all the aspects, including the storage conditions of Ranitidine. Also it suggested that the Indian Council of Medical Research (ICMR) may conduct a study for assessing the safety of Ranitidine drug considering the presence of NDMA impurity. "The manufacturers should monitor the NDMA levels in the API/formulation and also take risk based measures such as reducing the shelf life etc," the communication said. "In view of above, as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life etc," it added.
Time of India
30-07-2025
- Health
- Time of India
Doors step delivery medicines under review: Govt in RS
Representative AI image NEW DELHI: India's top drug advisory body, the Drug Technical Advisory Body (DTAB), is reviewing whether doorstep delivery of medicines which was allowed by the govt during the Covid-19 pandemic should be continued or not. Minister of state in the health ministry Anupriya Patel said this in a written reply to a parliament question on Tuesday. The decision comes after a representation from the All-India Organisation of Chemists and Druggists demanding withdrawing govt approval for doorstep delivery of medicines citing alleged misuse and an increase in unauthorised sale of prescription drugs. Patel said the DTAB had considered the agenda for withdrawal of notification dated March 26, 2020 (to allow doorstep delivery of medicines) in a meeting held on April 24, 2025. There is no clarity on the DTAB's stand on the issue though. In 2020, the health ministry issued a notification to allow doorstep delivery of essential medicines as part of an effort to prevent people from coming out as nationwide lockdown was in place to prevent the spread of Covid-19. Retail shop owners have been protesting because permission remains in place even though the pandemic has ended.
Time of India
29-07-2025
- Health
- Time of India
Monitor presence of potentially carcinogenic chemical in Ranitidine: DCGI to drug controllers
New Delhi: Drug regulator DCGI has asked drug controllers of all states and Union Territories to direct manufacturers under their jurisdiction to monitor the presence of a potentially carcinogenic chemical -- N-Nitrosodimethylamine -- in antacid Ranitidine. Ranitidine is used to reduce the amount of acid the stomach makes and also in the treatment of acid reflux and stomach or intestinal ulcers among others. Explore courses from Top Institutes in Please select course: Select a Course Category Healthcare others Leadership Data Science Operations Management MBA Others Digital Marketing Management Data Science Product Management Public Policy Artificial Intelligence healthcare CXO Project Management Finance Design Thinking Data Analytics Degree Cybersecurity Skills you'll gain: Financial Analysis in Healthcare Financial Management & Investing Strategic Management in Healthcare Process Design & Analysis Duration: 12 Weeks Indian School of Business Certificate Program in Healthcare Management Starts on Jun 13, 2024 Get Details The issue related to safety of Ranitidine drug due to presence of N-Nitrosodimethylamine (NDMA) impurity has been under consideration for quite some time now and various measures have been taken from time to time, the Drugs Controller General of India (DCGI) said in a communication on July 24. An expert-committee was constituted in December last year and the report of the expert committee was placed before the 92nd Drugs Technical Advisory Board (DTAB) meeting in April this year, the communication, which also had minutes of the DTAB meeting as enclosures, said. The communication said DTAB, after detailed deliberation, recommended that a larger committee is required to be constituted which will look into all the aspects, including the storage conditions of Ranitidine. Live Events Also it suggested that the Indian Council of Medical Research (ICMR) may conduct a study for assessing the safety of Ranitidine drug considering the presence of NDMA impurity. "The manufacturers should monitor the NDMA levels in the API/formulation and also take risk based measures such as reducing the shelf life etc," the communication said. "In view of above, as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life etc," it added.
NDTV
27-07-2025
- Health
- NDTV
Centre Flags Carcinogen Fears On Acidity Medicine Ranitidine, Orders Probe
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has directed all state and union territory drug regulators to ensure manufacturers of Ranitidine -- a commonly used acidity medicine --monitor NDMA levels, a potentially cancer-causing impurity, in both the active pharmaceutical ingredient (API) and formulations of the drug. The CDSCO has also suggested reducing the shelf life as a precautionary step. The move comes from the Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, following a recommendation by the Drugs Technical Advisory Board (DTAB) during its 92nd meeting on April 28, 2025. The Board reviewed a report submitted by an expert committee constituted in December last year to study the impurity concerns around Ranitidine. Based on this, DTAB has called for a larger committee to examine all aspects of the issue, including storage conditions that may contribute to NDMA formation. In addition, the Board recommended that the Indian Council of Medical Research (ICMR) conduct a study to further assess the long-term safety of Ranitidine in light of NDMA presence. Manufacturers have now been told to adopt risk-based measures, such as limiting shelf life, modifying storage recommendations, and enhancing NDMA testing protocols across their supply chains. "Ranitidine falls in the Group 2A carcinogen category, according to the International Agency for Research on Cancer (IARC), which implies that it is a probable human carcinogen. It should not be continued in prescription when there are safer alternatives such as Famotidine and Pantoprazole available," said Dr Abhishek Shankar, Oncologist, AIIMS Delhi. NDMA is classified as a probable human carcinogen, and its presence in medications has triggered global regulatory scrutiny over recent years. Ranitidine, commonly prescribed for acid reflux and ulcers, was withdrawn from several markets, including the US, after alarmingly high levels of NDMA were found in some samples. "Ranitidine was commonly prescribed in the past. Its usage has reduced in most metro cities, but it is still prescribed in Tier 1 or 2 cities, particularly at primary healthcare centres. In my knowledge, the drug has been known to have NDMA impurities; the FDA has also ruled out the use of this drug in large doses. The DGCI needs to set prescribed limits for NDMA levels in this drug," said Dr Lohit Chauhan, Gastroenterologist at Max Dwarka.
News18
27-07-2025
- Health
- News18
Ask Antacid Ranitidine Makers To Monitor Chances Of Cancer-Causing Impurity: Drug Controller To States
NDMA presence in the acid-reflux drug under scrutiny again; states told to ensure manufacturers take risk-based safety steps In a renewed move to safeguard public health, the Drugs Controller General of India (DCGI) has directed all state and union territory drug regulators to ensure that manufacturers of Ranitidine—a commonly used medicine for acidity—monitor levels of NDMA, a potential cancer-causing impurity, in their formulations. Ranitidine is a medication that lowers stomach acid production and helps relieve acid-related indigestion and heartburn. It is commonly available under brand names like Aciloc, Rantac, and Zinetac. The July 24 communication, seen by News18, follows the findings of a government-appointed expert committee and a subsequent meeting of the Drugs Technical Advisory Board (DTAB), the country's apex drug advisory body. The DTAB, in its 92nd meeting held on April 28, reviewed the expert panel's report on the NDMA contamination issue that has shadowed Ranitidine for several years. 'The issue related to safety of Ranitidine drug due to presence of NDMA impurity has been under consideration for quite some time and this office has taken various measures from time to time," the letter said. News18 first reported the recommendations of the expert panel on April 29. Critically, the DTAB advised that 'manufacturers should monitor the NDMA levels in the API/formulation and also take risk-based measures such as reducing the shelf life" of the product. Following this, the DCGI has asked state drug controllers to instruct Ranitidine manufacturers in their jurisdiction to initiate these monitoring and mitigation efforts immediately. '…as recommended by DTAB, you are requested to direct the manufacturers under your jurisdiction to monitor the NDMA levels in the API/formulation of Ranitidine and also take risk-based measures such as reducing the shelf life, etc." NDMA (N-nitroso dimethylamine) is classified as a probable human carcinogen. The impurity was first flagged globally in 2019, prompting recalls and regulatory reviews in several countries. In India, too, concerns around Ranitidine's safety have persisted, although the drug remains on the market. With the DTAB's latest push, the spotlight is once again on the need for proactive safety checks and strict quality surveillance by drugmakers, especially for older drugs that continue to see wide usage. view comments First Published: July 27, 2025, 07:00 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
