Archive · 29 Jul 2025
India's Drug Regulator to Monitor Potential Carcinogen in Ranitidine
The Indian drug regulator is making sure a medicine called Ranitidine is safe.
Ranitidine helps with stomach problems.
They're checking for a potentially harmful chemical called NDMA in the medicine.
If too much NDMA is present, the medicine might not be safe to use.
The government wants drug companies to test their Ranitidine and take steps like shortening how long the medicine is good for.
Experts are also studying the medicine to ensure it's safe for everyone.
DCGI directs drug controllers to monitor a potentially carcinogenic chemical in Ranitidine.
The chemical of concern is N-Nitrosodimethylamine (NDMA).
Ranitidine is an antacid used to reduce stomach acid and treat ulcers.
DTAB recommended a larger committee to investigate all aspects of the drug.
Manufacturers are asked to monitor NDMA levels and take risk-based measures, like reducing shelf life.
- Who
- Drug Controller General of India (DCGI)
- What
- Drug regulator directs manufacturers to monitor the presence of NDMA in Ranitidine.
- When
- July 2024
- Where
- India
- Why
- To ensure the safety of Ranitidine due to the presence of a potentially carcinogenic chemical, NDMA.
Patient Safety Advocates
Pharmaceutical Companies
Testing and Recall
Patient Safety Advocates
Prioritize immediate and comprehensive testing and potential recall.
Pharmaceutical Companies
Current monitoring is adequate given the scale and prevalence of the drug.
- Drug
- Ranitidine
- Concern
- NDMA (N-Nitrosodimethylamine)
- Purpose of Ranitidine
- Reduce stomach acid, treat ulcers
- Action
- Monitor NDMA levels
- Recommendation
- Reduce shelf life if needed