1 week ago
India Launches Seven Nitrosamine Standards to Detect Carcinogens
India has created seven special testing materials for checking medicines.
These materials help laboratories look for harmful chemicals called nitrosamines.
Nitrosamines can sometimes get into medicines during manufacturing, storage or packaging.
Some of these chemicals can damage genetic material and may cause cancer.
The new standards act like measuring rulers for laboratories.
They will help scientists find out how much of these impurities is present.
The standards can also support drug-quality checks and government rules.
They were introduced by the Indian Pharmacopoeia Commission at a meeting in Kolkata.
The Indian Pharmacopoeia Commission launched reference standards for seven nitrosamine impurities in medicines.
The standards cover NDMA, NDEA, NEIPA, NDBA, NMPA, NDIPA and NMBA.
Nitrosamines can arise during drug manufacturing, storage, packaging or contamination from production materials.
The standards will help laboratories detect and measure impurities, validate methods and support regulatory compliance.
The standards were launched at an expert meeting in Kolkata as India seeks stronger and more internationally aligned drug-quality testing.
- Who
- The Indian Pharmacopoeia Commission, under India’s Union Ministry of Health and Family Welfare, launched the standards.
- What
- It launched reference standards for seven nitrosamine impurities that may occur in pharmaceutical products.
- Where
- The launch was held at the Central Drugs Laboratory and Central Cosmetics Laboratory in Kolkata, India.
- When
- The launch took place at a Tuesday meeting; the report was published on August 25, 2026.
- Why
- The standards are intended to improve the detection and measurement of potentially carcinogenic impurities, support drug testing and regulatory compliance, and align India with international quality standards.
Key facts
- Standards launched
- Seven nitrosamine reference standards
- Chemicals covered
- NDMA, NDEA, NEIPA, NDBA, NMPA, NDIPA and NMBA
- Health concern
- Nitrosamines are described as potent genotoxic and carcinogenic compounds.
- Main uses
- Drug-quality testing, analytical method validation, quality assurance and regulatory compliance
- Earlier Indian measure
- India introduced a general chapter on nitrosamine impurities in the Indian Pharmacopoeia in 2022.
- Launch venue
- Central Drugs Laboratory and Central Cosmetics Laboratory, Kolkata
- Launch meeting
- “IP 2026: Perspectives, Suggestions & Way Forward”
Sources
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