The Zantac Settlement and Its Implications
In October 2024, GSK (GlaxoSmithKline) agreed to a $2.2 billion settlement in the U.S. to resolve lawsuits concerning its popular drug, Zantac, which treats acid reflux.
It was discovered that Zantac contained high levels of NDMA (N-nitrosodimethylamine), a carcinogen that can cause cancer when consumed in high quantities.
American pharmacy Valisure found NDMA levels exceeding 3 million nanograms in some Ranitidine samples, far above the U.S. limit of 96 nanograms.
Ranitidine and Its Global Withdrawal
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) stopped Ranitidine sales in 2020 due to NDMA contamination concerns.
Despite global withdrawals, India has continued to allow the sale of Ranitidine.
The Ministry of Health in India has taken no action since 2020, and the government has not halted the sale of this drug.
Why the Indian Government Has Not Acted
The Indian government has failed to detect or address the NDMA issue in Ranitidine, despite the drug being widely consumed in India.
There are safer alternatives for treating acidity, such as famotidine and esomeprazole, but Ranitidine continues to be sold without restriction.
Role of the Indian Pharmacopeia Commission (IPC)
The IPC is responsible for setting drug quality standards, including permissible impurity limits like NDMA levels in Ranitidine.
The IPC has not published updated standards for NDMA in Ranitidine, and the latest version of the Indian Pharmacopeia is not readily accessible to the public.
Drug manufacturers should be tested against IPC standards, but it is unclear whether testing for NDMA is being carried out effectively by the Indian authorities.
The Legal Authority and Need for Action
Under Section 26A of The Drugs and Cosmetics Act, 1940, the Ministry of Health holds the power to ban the sale of unsafe drugs.
The Drug Regulation Section within the Ministry of Health lacks sufficient technical knowledge about pharmaceuticals and pharmacology, which weakens its ability to take action.
After the $2.2 billion settlement, it is time for the Ministry of Health to act swiftly and prohibit Ranitidine sales in India, ensuring public safety.
Way Forward
The government should issue an immediate order under Section 26A of The Drugs and Cosmetics Act to prohibit the manufacture and sale of Ranitidine.
The IPC should update its standards regarding NDMA in Ranitidine and make the Indian Pharmacopeia accessible to the public.
Ensuring that drugs sold in India meet global safety standards is essential for protecting public health and preventing further health risks linked to NDMA exposure.
COMMENTS