Date: 2026-06-24Category: Press ReleaseState: Union GovernmentCountry: India
IPC Successfully Conducts 2nd Hands-on Training on Ethylene Glycol (EG) and Diethylene Glycol (DEG) Determination in Oral Liquid Preparations by Gas Chromatography
**Executive Summary**
The Indian Pharmacopoeia Commission (IPC) conducted its second hands-on training program from June 22nd to 23rd, 2026, focusing on the determination of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in oral liquid preparations using Gas Chromatography. The program aims to strengthen the analytical capabilities of state regulatory laboratories to ensure compliance with Amendment List 09 to IP–2022, which mandates this testing effective October 10th, 2025. Participants from six states received practical training to safeguard public health against toxic pharmaceutical contaminants.
**Key Points / Main Content**
**Training Objectives and Methodology**
* **Practical Skills:** Provided intensive hands-on exposure to sample preparation, instrument operation, calibration, and analytical method implementation.
* **Data Analysis:** Participants were trained in chromatogram interpretation and data analysis specifically for Gas Chromatography (GC).
* **Knowledge Sharing:** Facilitated the exchange of technical expertise among government drug analysts and regulatory laboratories.
**Toxicological Concerns and Contamination**
* **Health Risks:** EG and DEG are highly toxic and can cause acute kidney injury, central nervous system depression, and death.
* **Prohibited Substances:** These contaminants are strictly not permitted in pharmaceutical formulations.
* **Sources of Adulteration:** Contaminants may enter the supply chain through substandard excipients, including glycerin, propylene glycol, sorbitol, and polyethylene glycol.
**Regulatory Compliance and Standards**
* **Mandatory Testing:** The training aligns with Amendment List 09 to IP–2022, requiring mandatory EG and DEG testing for all oral liquid formulations.
* **Implementation Date:** The regulatory requirement becomes effective on October 10th, 2025.
* **Pharmacopoeia Standards:** The initiative supports the effective implementation of Indian Pharmacopoeia (IP) standards across State Drug Testing Laboratories.
**Impact Analysis**
**State Drug Testing Laboratories (Haryana, Goa, Odisha, West Bengal, Assam, and Meghalaya)**
**Impact**
Analysts have significantly enhanced their technical competence and practical skills in advanced analytical methods required for routine medicine testing.
**Action Required**
Laboratories must implement these analytical methods to comply with mandatory IP standards and ensure accurate quantification of contaminants in oral liquids.
**Indian Pharmacopoeia Commission (IPC)**
**Impact**
Reinforces the IPC’s role as a provider of technical support and capacity building for the national regulatory framework.
**Action Required**
Continue providing specialized training and technical assistance to State and Union Territory laboratories to maintain the quality and safety of medicines.
**Pharmaceutical Regulatory Framework**
**Impact**
Strengthens the overall oversight mechanism for ensuring the safety, efficacy, and quality of medicines available to the public.
**Action Required**
Ensure the rigorous enforcement of Amendment List 09 to IP–2022 starting from the effective date in October 2025.
Key Entities Referenced
Indian Pharmacopoeia Commission (IPC): The primary regulatory body under the Ministry of Health and Family Welfare responsible for setting drug standards and conducting the training program.
Amendment List 09 to IP–2022: The specific regulatory mandate that requires testing for Ethylene Glycol (EG) and Diethylene Glycol (DEG) in all oral liquid pharmaceutical formulations.
State Drug Testing Laboratories: The primary entities whose analytical capacity and technical competence are being strengthened to ensure medicine safety and quality across various Indian states.
Dr. V. Kalaiselvan: Secretary-cum-Scientific Director of the IPC who led the initiative to enhance laboratory capabilities for the effective implementation of pharmacopoeial standards.
Ministry of Health and Family Welfare
IPC Successfully Conducts 2nd Hands-on
Training on Ethylene Glycol (EG) and Diethylene
Glycol (DEG) Determination in Oral Liquid
Preparations by Gas Chromatography
Importance of Strengthening Analytical Capabilities of
Regulatory Laboratories for Ensuring the Quality, Safety and
Efficacy of Medicines Emphasized
Participants from Haryana, Goa, Odisha, West Bengal, Assam
and Meghalaya Receive Practical Training on Advanced
Analytical Methods for Ensuring Medicine Safety and Quality
Training Programme Strengthens Capacity of State Drug
Testing Laboratories for Effective Implementation of Indian
Pharmacopoeia Standards
प्रव तथ: 24 JUN 2026 5:01PM by PIB Delhi
The Indian Pharmacopoeia Commission (IPC) successfully conducted the 2nd Hands-on Training
Programme on the Determination of Ethylene Glycol (EG) and Diethylene Glycol (DEG) in Oral Liquid
Preparations by Gas Chromatography (GC) from 22nd to 23rd June 2026 at its campus in Ghaziabad.
The training programme was inaugurated by Dr V. Kalaiselvan, Secretary-cum-Scientific Director, IPC, in
the presence of Shri Rajeev Bhargava, Deputy Drugs Controller (DDC), Department of Drugs Control,
Delhi, who graced the occasion as the Guest of Honour. During the inaugural session, the importance of
strengthening analytical capabilities of regulatory laboratories for ensuring the quality, safety, and efficacy
of medicines was emphasized.
The two-day programme brought together participants from six states including Haryana, Goa, Odisha,
West Bengal, Assam, and Meghalaya, and provided intensive practical training on the determination of EG
and DEG in oral liquid formulations using Gas Chromatography. The participants received hands-on
exposure to sample preparation, instrument operation, calibration, analytical method implementation,
chromatogram interpretation and data analysis.
Ethylene Glycol (EG) and Diethylene Glycol (DEG) are highly toxic substances that are not permitted in
pharmaceutical formulations. These contaminants may be introduced through adulterated or substandard
excipients such as glycerin, propylene glycol, sorbitol, and polyethylene glycol. Even trace quantities canpose serious health risks, including acute kidney injury, central nervous system depression, and death.
Therefore, their accurate detection, quantification, and control are essential for safeguarding public health
and ensuring pharmaceutical quality.
The training programme was organized in the context of Amendment List 09 to IP–2022, effective from
10th October 2025, which mandates testing for Ethylene Glycol (EG) and Diethylene Glycol (DEG) in all
oral liquid formulations. Through this initiative, IPC continues to support the effective implementation of
Indian Pharmacopoeia standards and strengthen the analytical preparedness of State Drug Testing
Laboratories across the country.
The technical sessions covered the scientific basis of DEG and EG contamination, regulatory
requirements, analytical methodology, and practical application of Gas Chromatography for routine
testing. Participants also gained insights into potential sources of contamination and the critical role of
quality control measures in preventing the entry of toxic contaminants into pharmaceutical products.
The programme significantly enhanced the technical competence of government drug analysts and
facilitated knowledge sharing among regulatory laboratories. The hands-on approach enabled participants
to develop practical skills required for accurate analysis and compliance with pharmacopoeial
requirements.
The Indian Pharmacopoeia Commission remains committed to providing technical support, capacity
building, and specialized training to State and Union Territory Drug Testing Laboratories to facilitate
effective implementation of Indian Pharmacopoeia standards and strengthen the regulatory framework for
ensuring the availability of safe, effective, and quality medicines to the public.
*****
SR
HFW/IPC Holds 2nd Training on GC-Based EG & DEG Determination/24June 2026/1
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