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In the backdrop of growing concerns around contaminated cough syrups in the supply chain, the Indian Pharmacopoeia Commission (IPC) will be conducting hands on training for public drug testing labs in 10 states in November in its first phase of training programmes, according to official sources.
These training programmes, in its first phase, will prominently feature training in gas chromatography (GC) for testing contamination with high levels of ethylene glycol (EG) and diethylene glycol (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 will participate in the training. Workshops in the first phase will be conducted in the ten states, which include states of Tamil Nadu, Rajasthan, Madhya Pradesh, Haryana, Telangana and Maharashtra among others. These workshops will be conducted in other states and Union Territories in phase wise manner, according to official sources.
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.
Gas chromatography with mass spectrometry (GC-MS) is considered the gold standard for detecting DEG and EG in medicines. 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.
The chapter includes General Chapter {2.4.13} Gas Chromatography - Analytical procedure for performing gas chromatography and general monograph oral liquids - mandatory quality tests to be performed on finished formulations.
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