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Following the success of training programmes of public drug testing labs in 10 states in the country, the Indian Pharmacopoeia Commission (IPC) is all set to launch pan-India capacity building programme for all central and state public testing labs to ensure patient safety.
There are 8 Central Drugs Testing Laboratories (CDTLs) and 29 drug testing laboratories set up by states/UTs.
“The programmes are intended to ensure analytical accuracy and traceability of medicines with the introduction of IP Reference Standards (IPRS) and also analytical procedure for performing gas chromatography (GC). The relevant IPRS materials available through the IPC are diethylene glycol (DEG) IPRS, ethylene glycol (EG) IPRS, glycerin (glycerol) IPRS, propylene glycol IPRS, sorbitol IPRS and maltitol (mannitol impurity B) IPRS,” informed an official associated with the development.
The IPC, in the month of November 2025, conducted hands on training for public drug testing labs in 10 states on GC for testing contamination with high levels of EG and DEG in medicines.
The IPC has developed a free toolkit by compiling pharmacopoeial and regulatory resources to address contamination with high levels of EG and DEG associated with liquid oral medicines, particularly in allergy, cold, and cough syrups. This document serves as a comprehensive reference, compiling key general chapters and monographs from the IP, available reference standards, along with relevant international guidance’s. The resources are intended to support excipients and raw material suppliers, drug manufacturers, testing laboratories, and regulatory agencies.
Two officials of drug testing labs from each of the 10 states participated in the training. The ten states, included states of Tamil Nadu, Rajasthan, Madhya Pradesh, Haryana, Telangana and Maharashtra among others.
IPC, an autonomous Institution of the Union Health ministry publishes Indian Pharmacopoeia (IP) to ensure quality and safe medicines by establishing pharmacopoeial standards and providing reference substances to the pharma industry.
The World Health Organization (WHO) and other health authorities have established methods based on GC-MS to ensure that levels of DEG and EG in products are below safety thresholds.
General chapters and general monographs in the IP provide foundational principles, standardized test methods, and quality assurance procedures that are applicable across multiple monographs. These chapters serve as essential references for ensuring consistency in analytical testing and manufacturing practices.
In the context of DEG and EG contamination, relevant general chapters have also been introduced to offer validated methods and quality control frameworks that help manufacturers detect impurities, assess excipient integrity, and maintain compliance with pharmacopoeial standards. By implementing these chapters effectively, stakeholders can strengthen control over high-risk excipients and safeguard the quality and safety of liquid oral formulations.
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