Kolkata, August 25: The Indian Pharmacopoeia Commission (IPC), under the Ministry of Health and Family Welfare, organized an interactive meeting at the Central Drug Laboratory (CDL) and the Central Cosmetics Laboratory (CCL) in Kolkata. This meeting marked the first of its kind in West Bengal, where experts and stakeholders discussed enhancing drug standards and quality across the country.
The focus was on the theme “IP 2026: Perspectives, Suggestions, and the Way Forward.” Discussions centered around the importance of official quality standards for drugs manufactured and sold in India, particularly in relation to the Indian Pharmacopoeia, ensuring drug quality, safety, and efficacy.
During the event, seven reference standards for nitrosamine impurities were introduced for the first time by the IPC. Nitrosamines are chemical compounds formed when amine-containing substances react with nitrites, and they are considered carcinogenic.
The newly released reference standards include N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), N-Nitrosoethylisopropylamine (NEIPA), N-Nitrosodibutylamine (NDBA), N-Nitrosomethylphenylamine (NAMPA), N-Nitrosodiisopropylamine (NDIPA), and N-Nitroso-N-methyl-4-aminobutyric acid (NAMBA).
Nitrosamines are potent genotoxic and carcinogenic compounds that can inadvertently form due to contamination from various materials used during manufacturing, storage, and packaging. It is crucial to control these impurities in medications used to treat hypertension, gastrointestinal disorders, diabetes, and tuberculosis.
The release of these seven reference standards will enhance the ability to accurately detect and quantify nitrosamine impurities in drug production. This initiative will support drug testing, method validation, quality assurance, and regulatory compliance. Additionally, it will aid in better adherence to international quality standards and promote self-reliance in critical reference materials.
Dr. V. Kalaiselvan, Secretary and Scientific Director of the Indian Pharmacopoeia Commission, emphasized the importance of a collaborative approach with the CDL laboratory to ensure drug quality during his inaugural address. Dr. Suparna Chatterjee, Professor and Head of the Pharmacology Department at the Institute of Post Graduate Medical Education and Research (IPGMER) in Kolkata, and Dr. Rakesh Kumar Rishi, Director of the Central Drug Laboratory, were also present at the event.
This meeting served as a significant platform for regulatory authorities, laboratories, and experts from the Indian Pharmacopoeia to share insights, suggestions, and strengthen the national drug quality ecosystem.
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