The Indian government has stated that it will not ban the manufacturing and selling of Ranitidine, a very widely prescribed heartburn drug even in the wake of anxieties about the presence of N-nitrosodimethylamine (NDMA) linked to cancer. This decision follows a global ban and continued banter on its safety.

Principal Insights
Government's Position:
During a session of Parliament, Anupriya Patel, the Union Minister of State for Health and Family Welfare, affirmed that there is currently no proposal to ban the production, distribution, or sale of ranitidine in India.

Global Issues:

• Ranitidine was banned or suspended in the US, Europe, and Australia since 2019 due to USFDA's concern about the potential carcinogenic properties of NDMA.

• Notwithstanding these prohibitions, the Indian government states that levels of NDMA in ranitidine sold in the country remain within acceptable limits.

NDMA and Safety Testing:

• The International Agency for Research on Cancer, an arm of the World Health Organization, labeled NDMA as a "probable carcinogen".

• The Central Drugs Standard Control Organisation has implemented strict safety measures:

• Samples of ranitidine are screened for NDMA impurities.

• State drug regulators have been instructed to validate and evaluate ranitidine products to ensure that all the safety standards are being met.

Clinician Insights:

• Experts emphasized ranitidine’s safety and efficacy, especially for treating acidity and ulcers.

• Dr. Rajeev Jayadevan, a gastroenterologist, stated that large-scale studies have not conclusively linked ranitidine use to an increased risk of cancer.

Scientific Perspective:

• NDMA is a byproduct of the manufacturing process in the production of alkylamines and also occurs naturally during food digestion.

• Pharmacologists have elucidated that although the molecule has the potential to degrade into NDMA under certain circumstances, the clinical evidence associating ranitidine with cancer remains limited.

India's Approach:

• In 2022, Ranitidine was removed from the National List of Essential Medicines (NLEM); however, it remains a widely used and cost-effective treatment option in India.

• CDSCO has established NDMA acceptable intake limits in the Indian Pharmacopoeia (IP) 2022 and continues to monitor the drug’s safety.

• Industry Implications Due to this, the pharmaceutical giants are being sued globally, especially by Pfizer, Sanofi, and Boehringer Ingelheim.

What This Means for Pharmacists:

• Ranitidine’s Popularity: Despite global concerns, the drug continues to be a cost-effective treatment in India.

• Compliance Focus: Pharmacists must ensure ranitidine products comply with NDMA safety thresholds as per IP 2022.

• Patient Counseling: It is imperative for pharmacists to inform patients regarding potential issues, while simultaneously presenting alternative therapeutic choices, including proton pump inhibitors (PPIs).