Ranitidine Hydrochloride

New Delhi: Amid the renewed scrutiny of popular antacid ‘Ranitidine’, following the recommendation by the top drug advisory board, India’s apex regulator has directed the country's drugmakers to monitor the levels of NDMA in the API and formulation of the drug. Issuing a directive to state drug controllers, the Drugs Controller General of India (DCGI) ordered the regulators “to direct the manufacturers under their 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.” The directive has been issued following the recommendation by the Drug Technical Advisory Board , which had proposed, “the manufacturers should monitor the NDMA levels in the APl/formulation and also take risk based measures such as reducing the shelf life etc.” Ranitidine is a popular small molecule indicated for the treatment of indigestion, heartburn, acid reflux etc and is marketed by a number of MNC and domestic companies in India under their respective brand names. However, the drug has been linked to health concerns, including cancer risks, due to the presence of NDMA (N-Nitrosodimethylamine) at levels exceeding acceptable limits. Notably, the directive issued by the apex regulator notes that, “the issue related to safety of Ranitidine drug due to presence of NDMA impurity has been under consideration for quite some time. Following an investigation, in April 2020, the US FDA had ordered the withdrawal of all Over-The Counter (OTC) and prescription ranitidine products from the country’s market due to the exceeding levels of NDMA. Under its investigation the US regulator had determined that the impurity (NDMA) in some ranitidine products “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.” In India, after reviewing the report of an expert committee formed by the CDSCO in December 2024, at its 92nd meeting, DTAB members recommended to constitute a larger committee “which will look into all the aspects including the storage conditions of the drug.” Additionally, the top advisory board had also proposed an lCMR-executed study for assessing the safety of the drug considering the presence of NDMA impurity. By Abhijeet Singh ,

The case is set for further proceedings in Delaware after the state's highest court disallowed expert testimony. In the latest twist in the ocean of Zantac-related litigation playing out across state courts, drugmakers have notched a key win in Delaware.With a Thursday ruling (PDF) from Delaware’s highest court, GSK, Pfizer, Sanofi and Boehringer Ingelheim won’t have to defend against testimony from 10 doctors and scientists who support the claim that ingesting the now-off-market heartburn medicine can cause cancer.Nearly 75,000 personal injury complaints are wrapped up in the Delaware litigation, all of which are from plaintiffs who allege that consuming Zantac’s active ingredient, ranitidine, caused their cancer diagnoses before the drug was pulled from the market in 2020. To help make their case, the plaintiff group retained ten experts to offer general causation opinions that explain how the drug could be capable of causing each of the ten types of cancer at issue.The drugmakers previously moved to exclude the testimony at the Superior Court of Delaware. With that court denying the attempt, the companies were left to take it up with the Delaware Supreme Court on appeal. GSK’s shares rose 4% when the court opted to review the matter last summer.In the Delaware Supreme Court’s ruling, Justice Abigail M. LeGrow pointed to a few “problems with Plaintiffs’ experts’ analysis and conclusions,” noting that the Superior Court did not “address these gaps.” Ultimately, the Delaware Supreme Court found that the plaintiffs did not “carry their burden to establish the admissibility of their general causation experts’ opinions by a preponderance of the evidence,” ruling to reverse the prior court's decision.Now, the case will bounce back to the Superior Court for “further proceedings consistent with this decision,” according to LeGrow’s opinion.Expert evidence is a key factor in the progression of Zantac litigation. Last summer, a Florida court opted to toss experts’ general and specific causation testimony that aimed to link Zantac to a plaintiff’s prostate cancer, leading GSK to pursue dismissal of the case. GSK developed brand-name Zantac in the 1980s and has long defended the safety of the heartburn med. In a statement last year, the company said there's “no consistent or reliable evidence that ranitidine increases the risk of any cancer.” “Since 2019, there have been 16 epidemiological studies looking at human data regarding the use of ranitidine, including outcomes for more than 1 million patients using ranitidine, supporting this consensus,” GSK added.Still, GSK has moved to settle many of the thousands of Zantac-related claims. Last fall, GSK agreed to pay up to $2.2 billion to resolve some 80,000 lawsuits, freeing it from litigating 93% of the state court cases it faced in the U.S. Sanofi previously consented to paying $100 million to clear about 4,000 Zantac claims, Bloomberg reported last April. Pfizer, too, settled some 10,000 cases for an undisclosed figure last year. Sanofi and Pfizer were among the companies that sold an over-the-counter version of Zantac after the drug went off patent.