NEW DELHI, AUG 25 (PTI): The Indian Pharmacopoeia Commission (IPC) has launched seven standards to strengthen the detection and quality control of potentially harmful impurities in pharmaceutical products.
The Indian Pharmacopoeia Nitrosamine Impurities Reference Standards were launched during an interactive meeting organised by the IPC at the Central Drugs Laboratory (CDL) and Central Cosmetics Laboratory (CCL) in Kolkata.
The meeting, which brought together experts and stakeholders to discuss pharmacopoeial standards and drug quality in the country, focused on “IP 2026: Perspectives, Suggestions & Way Forward” and the role of Indian Pharmacopoeia Reference Standards and Impurity Standards in ensuring the quality, safety and efficacy of medicines, a health ministry statement said.
The seven nitrosamine reference standards launched by the IPC are N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodibutylamine (NDBA), N-Nitrosomethylphenylamine (NMPA), N-Nitrosodiisopropylamine (NDIPA) and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
Nitrosamines are potent genotoxic and carcinogenic compounds that can unintentionally arise during pharmaceutical manufacturing, storage and packaging, or through contamination from materials used in drug production.
Controlling such impurities is particularly important for certain medicines used in the treatment of hypertension, gastric disorders, diabetes and tuberculosis.
The launch of these seven impurities reference standards represents a significant step towards strengthening India’s capability for the accurate detection and quantification of nitrosamine impurities in pharmaceuticals, the statement said
The initiative will support pharmaceutical testing, method validation, quality assurance and regulatory compliance, while further promoting harmonisation with international quality standards and self-reliance in critical reference materials, it stated. Dr V Kalaiselvan, Secretary-cum-Scientific Director, IPC, during the inaugural address, highlighted the collaborative approach with CDL is crucial in ensuring the quality of medicines.
Dr Suparna Chatterjee, Professor and Head of Pharmacology, IPGMER Kolkata, Dr Rakesh Kumar Rishi, Director- CDL also attended the meeting.
The interactive meeting, held for the first time in Kolkata, provided a platform for experts from regulatory authorities, laboratories and the IPC to exchange views and suggestions on further strengthening the Indian Pharmacopoeia and the country’s drug quality ecosystem.
Wednesday, August 26, 2026