Monitor NDMA levels in antacid Ranitidine: Drugs body CDSCO
NDMA (N-nitrosodimethylamine) is a chemical which has been recognised as a probable carcinogen by International Agency for Research on Cancer (IARC), reports Durgesh Nandan Jha.
CDSCO's decision came after reports of NDMA impurity in the medicine. An expert panel was appointed to deliberate on the concern in Dec last year. Sources said the the committee's recommendations were deliberated in a meeting of Drug Technical Advisory Body recently.
DTAB recommended that a larger committee be constituted to look into all aspects, including storage conditions of Ranitidine, and also suggested that the Indian Council of Medical Research undertake a study to assess the drug's safety in addition to directing manufacturers to monitor NDMA levels in the drug and, if required, take risk-based measures such as reducing the shelf life.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
India Today
35 minutes ago
- India Today
What is hepatitis D, the deadly viral disease now given a cancer tag by WHO?
Hepatitis D is now tagged as a cancer-causing infection by the World Health Organisation. The health agency's cancer arm, the International Agency for Research on Cancer, called hepatitis D a carcinogen as the little-known virus can silently raise the risk of liver cancer, just like hepatitis B and is a viral infection that inflames the liver. Of the five main types – A, B, C, D and E – the B, C and D strains are the most dangerous because they can stick around for years, damaging the liver estimates that over 300 million people live with chronic hepatitis B, C, or D infections, and 1.3 million die each year from related diseases. Most don't even know they're infected until the damage is already done. Hepatitis D is different from the others. It only infects people who already have hepatitis B, but together, the two viruses are far more harmful. According to WHO, having both increases the risk of liver cancer two to six times compared to hepatitis B virus spreads through infected blood, unprotected sex, unsafe injections, or occasionally from mother to child during if they appear, are usually vague and includes fatigue, nausea, abdominal discomfort, dark urine or yellowing of the skin. Many people ignore these signs or confuse them with other isn't a separate vaccine for hepatitis D. The only way to stop it is by getting the hepatitis B vaccine, which protects against both viruses. WHO says 147 countries now offer newborn vaccinations, but testing and treatment for existing cases still lag far it comes to the treatment of hepatitis D, medications are still evolving. However, the full benefit of reducing liver cirrhosis and cancer deaths can only be realised through urgent action to scale up and integrate hepatitis services – including vaccination, testing, harm reduction, and treatment – into national health experts say better awareness, early screening and wider access to treatment could save millions of lives by 2030. For now, the key advice is simple: get vaccinated, get tested, and don't ignore liver health.- Ends
Hindustan Times
a day ago
- Hindustan Times
Health Talk: Taking the road to hepatitis elimination
The International Agency for Research on Cancer (IARC) recently classified hepatitis D as carcinogenic—cancer-causing—to humans, just like hepatitis B and C. Hepatitis D, which only affects individuals infected with hepatitis B, is associated with a two- to six-fold higher risk of liver cancer compared to hepatitis B alone, it added. (AP/ Representative photo) Hepatitis D, which only affects individuals infected with hepatitis B, is associated with a two- to six-fold higher risk of liver cancer compared to hepatitis B alone, it added. Viral hepatitis – types A, B, C, D, and E – are major causes of acute liver infection. Among these, only hepatitis B, C, and D can lead to chronic infections that significantly increase the risk of cirrhosis, liver failure, or liver cancer. Each year, July 28 is observed as World Hepatitis Day, as viral hepatitis continues to remain a serious public health threat and one of the primary causes of liver cancer. Yet most people with hepatitis don't know they're infected, says the World Health Organization (WHO). According to the UN health body, types B, C, and D affect at least 300 million people globally and cause at least 1.3 million deaths each year, mainly from liver cirrhosis and cancer. In a paper published on Monday, The Lancet Commission also mentioned that three in five liver cancer cases happen due to preventable risk factors, including fatty liver, alcohol, and viral hepatitis. It also added that obesity-linked cancer cases are on the rise. The majority of liver cancer cases can be prevented by reducing levels of viral hepatitis, alcohol consumption, and MASLD (metabolic dysfunction-associated steatotic liver disease – previously called non-alcoholic fatty liver disease), it said. Liver cancer is already a major cause of death and disability. Globally, it's the sixth most common cancer and the third leading cause of death from cancer. Interestingly, the Commission estimated in the paper that at least 60% of liver cancers are preventable via control of modifiable risk factors, including hepatitis B virus (HBV), hepatitis C virus (HCV), MASLD, and alcohol. While there are preventive measures and treatment available to combat this public health threat, last year's Global Hepatitis Report underscored some challenges that majorly impact disease management. According to the report, testing and treatment coverage remain critically low: only 13% of people with hepatitis B and 36% with hepatitis C had been diagnosed by 2022. Treatment rates were even lower – 3% for hepatitis B and 20% for hepatitis C – well below the 2025 targets of 60% diagnosed and 50% treated. Integration of hepatitis services remained uneven: 80 countries have incorporated hepatitis services into primary health care, 128 into HIV programmes, and just 27 have integrated hepatitis C services into harm reduction centres. The next challenge, according to the report, will be to scale up the implementation of prevention, testing, and treatment coverage. Achieving WHO's 2030 targets could save 2.8 million lives and prevent 9.8 million new infections. With declining donor support, countries must prioritize domestic investment, integrated services, better data, affordable medicines, and ending stigma, said experts in the report. 'Every 30 seconds, someone dies from a hepatitis-related severe liver disease or liver cancer. Yet we have the tools to stop hepatitis,' WHO director-general Tedros Adhanom Ghebreyesus said in a statement on World Hepatitis Day. He is right. We have the tools at our disposal; all we need is for stakeholders—governments, civil society, community leaders, etc.—to come together, to jointly work towards eliminating hepatitis.
Mint
3 days ago
- Mint
India unveils first formal rules for drug approval panels in regulatory overhaul
New Delhi: India has issued its first formal playbook for how expert panels should vet new drugs, biologics and medical devices—a move aimed at fixing long-standing concerns about inconsistent and opaque approvals that have delayed critical drug launches and eroded industry trust in the regulatory system. The guidelines, issued by the Central Drugs Standard Control Organization (CDSCO), represent a major overhaul of India's drug approval process and aim to make regulatory decisions faster, more predictable and transparent, according to two government officials and documents reviewed by Mint. The guidelines standardize how Subject Expert Committees (SECs) are formed, how members are selected, and how they must evaluate applications, including the scientific benchmarks and disclosure norms they must follow. The SECs advise the Drugs Controller General of India (DCGI) on whether to clear new drugs, and their decisions have long shaped the trajectory of India's pharmaceutical industry. The CDSCO finalized the guidelines about two weeks ago and circulated them to SEC members for immediate implementation, the officials said. The overhaul follows recommendations from the World Health Organization (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organization. The WHO called for stronger transparency and data integrity to align India's system with global standards. India's pharmaceutical industry ranks third globally by volume and 14th by value. It accounts for roughly 20% of the world's generic drug supply and manufactures more than 60,000 products across 60 therapeutic areas. The sector also includes over-the-counter drugs, vaccines, contract manufacturing, biologics and biosimilars. As part of its findings, the WHO urged Indian authorities to implement stronger controls to prevent, detect, and respond to substandard and falsified medical products; to launch a market surveillance program for drug quality monitoring; and to ensure that promotional and advertising claims for medicines are not misleading. These steps are now being implemented by the DCGI and other stakeholders involved in the SEC meetings, according to the officials cited earlier. The SECs play a central role in India's drug approval process, advising the DCGI on whether to approve new drugs, biologics, and medical devices. Each committee includes eight experts—one pharmacologist and seven specialists from research, medical, or regulatory institutions—and requires a four-member quorum to issue recommendations. In the absence of formal guidelines, though, these decisions were often viewed as inconsistent or opaque, delaying product approvals. 'SECs are subject expert committees involved in evaluating approvals of new drugs. Simplification and streamlining the process will help industry in getting drugs approved with predictable speed and more transparency. We appreciate the step taken by DCGI," said Dr. Viranchi Shah, national spokesperson of the Indian Drugs Manufacturers Association (IDMA). Emailed queries to the spokesperson for the health ministry went unanswered at the time of publishing. Clearer mandate, tougher benchmarks According to the guidance document, SEC members must meet strict selection criteria, including a publication record of at least 10 peer-reviewed papers and a citation ratio of 2:1. Experts are appointed for a three-year term and are expected to maintain confidentiality, impartiality, and active participation. Those who fail to attend meetings regularly may be removed. The document specifies that SECs must offer rigorous, science-based evaluations on safety, efficacy, and risk-benefit balance. It outlines the dos and don'ts of deliberations: clinical trial waiver decisions must include clear yes/no recommendations with detailed justifications, and all discussions must remain focused on scientific and regulatory issues, excluding matters such as pricing. 'For new drug and clinical trial applications, the DCGI refers them to the SEC, an expert body that discusses proposals and offers recommendations for approval or rejection. These experts, being external to CDSCO, are not always fully aware of regulatory requirements. This often led to differing, sometimes subjective opinions, a lack of uniformity in decisions, and delays on straightforward matters. Therefore, it's important for the committee to provide uniform decisions, maintain transparency, and offer proper reasoning for approvals and rejections," said one of the two government officials cited earlier, who asked not to be named. The second official added, 'There were persistent discussions during SEC meetings about the absence of a guiding document to regulate or suggest proper functioning. This new guidance note outlines the 'do's and don'ts' for experts. Previously, some companies had even alleged that SEC meetings were not being conducted properly." While officials declined to cite specific past incidents, people familiar with the matter said the lack of consistency and alignment among SEC experts, who advise on key regulatory decisions, had severely affected the functioning of the DCGI in recent years. Industry seeks consistency For years, pharmaceutical companies have raised concerns over the unpredictability of SEC verdicts, especially around clinical trial waivers, which are critical for expediting the launch of generics and biosimilars. The new rules aim to reduce such uncertainty by standardizing decision-making across similar products, unless clear scientific reasons justify a deviation. The document states: 'The SECs are indispensable in the CDSCO's evaluation process due to their specialized expertise, independent perspective and commitment to quality assurance. These committees address complex scientific and regulatory challenges, fostering informed decision-making. By operating transparently and consistently across applications, SECs bolster public trust while safeguarding public health and promoting innovation in the healthcare sector." Public health experts have welcomed the reform. 'Any committee should operate under certain guidance, and it is always beneficial for all members of such a committee to have clarity and a common vision. It's akin to laying down the rules of the game," said Dr. Chandrakant Lahariya, a physician and public health expert. He added: 'The Subject Expert Committee (SEC) is an essential requirement for guiding the drug approvals and other processes in all regulatory bodies. When a new drug is needed, the SEC provides its recommendations to the apex drug regulator. CDSCO is a regulatory organization, and they need guidance from a technical expert committee to make decisions. A regulatory body needs guidance from those who deeply understand the subject."
