Ban this carcinogenic ‘heart-burn’ drug

Ban this carcinogenic ‘heart-burn’ drug

Sub: Sci

Sec: Health

Context:

• In 2020, Valisure, an American pharmacy, revealed that Ranitidine products, including Zantac, contained high levels of N-nitrosodimethylamine (NDMA).
• Ranitidine is a medication used to decrease stomach acid production.
• NDMA is a potent carcinogen, and prolonged exposure to high levels can increase the risk of cancer.

Use in India:

• The Indian government has not taken action to stop the sale of Ranitidine in the country, even though there are alternative drugs available.
• The Indian Pharmacopeia Commission (IPC), which sets standards for drug impurities, failed to detect the NDMA issue.
• Given the known health risks, there is increasing pressure for the Ministry of Health to take action and prohibit the sale of Ranitidine in India.

Regulatory Authority for banning Drugs:

• Under Section 26A of The Drugs and Cosmetics Act, 1940, the Ministry of Health, specifically the Drug Regulation Section, has the authority to prohibit the manufacture and sale of drugs in India if a public health concern is raised.

Indian Pharmacopeia Commission (IPC):

• The IPC is an autonomous body under the Ministry of Health responsible for setting standards for drugs, including permissible impurity levels and testing protocols.
• It publishes the Indian Pharmacopeia, which guides the quality control of pharmaceuticals in India.