Subject: GS 3: Science and Technology
Context: The Indian Pharmacopoeia Commission (IPC) conducted a specialised training programme on Gas Chromatography-based detection of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in oral liquid medicines to strengthen drug safety and quality control.
- Gas chromatography is an analytical technique used to separate, identify, and quantify the volatile components of a mixture by passing them through a column using a carrier gas
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Indian Pharmacopoeia Commission (IPC)
- The Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare responsible for setting official quality standards for drugs marketed in India.
- Nodal Ministry: IPC functions under the Ministry of Health and Family Welfare (MoHFW), with its headquarters located in Ghaziabad, Uttar Pradesh.
- Legal Status: The standards prescribed by IPC are legally enforceable under the Drugs and Cosmetics Act, 1940.
- Key Roles
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- Publishes the Indian Pharmacopoeia (IP), which specifies standards for the identity, purity and strength of medicines.
- Publishes the National Formulary of India (NFI) to promote the rational use of medicines.
- Serves as the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) and Materiovigilance Programme of India (MvPI).
- Develops and supplies Indian Pharmacopoeia Reference Standards (IPRS) for quality testing and conducts capacity-building programmes.
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About Ethylene Glycol (EG)
- Ethylene Glycol (C₂H₆O₂) is a colourless, odourless, sweet-tasting industrial alcohol that is highly toxic to humans and prohibited in pharmaceutical formulations.
- Petrochemical Production: EG is primarily produced by the hydration of ethylene oxide derived from petroleum feedstocks.
- Key Features
- Chemical Nature: EG is the simplest aliphatic diol with high water solubility and low volatility.
- Toxic Potential: Even small quantities can cause severe poisoning, acute kidney injury, and death.
- Cost Advantage: Its low cost compared to pharmaceutical-grade solvents makes it vulnerable to accidental or deliberate substitution.
- Applications
- Antifreeze Industry: EG is widely used in automotive coolants and antifreeze formulations.
- Polyester Manufacturing: It serves as a key raw material in the production of polyester fibres and PET bottles.
- Industrial Solvents: EG is used in hydraulic fluids, paints, inks, and chemical processing industries.
About Diethylene Glycol (DEG)
- Diethylene Glycol (C₄H₁₀O₃) is a colourless, odourless industrial solvent formed by linking two ethylene glycol molecules through an ether bond.
- By-product Formation: DEG is produced during the manufacture of ethylene glycol through ethylene oxide hydration processes.
- Key Features
- Chemical Structure: DEG possesses higher viscosity and boiling point than ethylene glycol.
- Industrial Utility: It functions as an effective solvent and moisture-absorbing agent.
- Pharmaceutical Risk: DEG contamination in excipients has caused multiple global medicine-related fatalities.
- Applications
- Textile Industry: DEG is used in textile lubricants and conditioning agents.
- Gas Processing: It is employed for dehydration of natural gas streams.
- Industrial Solvents: DEG is used in resins, dyes, and printing inks.
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Implications for Human Health
- Acute Kidney Injury (AKI): EG and DEG metabolites form toxic compounds that damage kidney tubules, causing renal failure.
- Neurological Toxicity: Exposure can result in central nervous system depression, seizures, coma, and death.
- Public Health Threat: Contaminated cough syrups and oral medicines containing EG/DEG have caused child fatalities in several countries, highlighting the need for stringent pharmaceutical regulation.