After Cough Syrup Deaths, IPC Issues Toolkit to Curb DEG, EG Contamination in Liquid Formulations

The IPC, which plays a central role in ensuring the safety, efficacy, and quality of medicines in India, said the toolkit is designed to serve as a comprehensive reference for excipients and raw material suppliers, drug manufacturers, testing laboratories, and regulatory authorities.

The initiative aligns with the government’s heightened focus on preventing toxic glycol contamination, which has been linked to several global incidents of child fatalities.

The newly issued resource compiles key general chapters and monographs from the Indian Pharmacopoeia (IP), reference standards, and relevant international guidance documents. It provides stakeholders with validated methods and frameworks to detect impurities, verify excipient integrity, and maintain compliance with established pharmacopeial standards.

By implementing these references, manufacturers can strengthen quality control mechanisms for high-risk excipients and ensure that liquid oral formulations meet safety norms.

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 offer validated methods and quality control frameworks that help manufacturers detect impurities, assess excipient integrity, and maintain compliance with pharmacopeial standards. By implementing these chapters effectively, stakeholders can strengthen control over high-risk excipients and safeguard the quality and safety of liquid oral formulations.

 General Chapter {2.4.13} Gas Chromatography—Analytical procedure for performing gas chromatography

 General Monograph Oral Liquids—Mandatory quality tests to be performed on finished formulations

Excipient Monographs Covered

Quality specifications for key excipients prone to contamination have been listed under the following IP monographs:

Glycerin

Liquid Maltitol

Polyethylene Glycol 1500

Polyethylene Glycol 4000

Polyethylene Glycol 6000

Propylene Glycol

Sorbitol Solution (70%) – Crystallising

Availability of IP Reference Standards (IPRS)

To ensure analytical accuracy and result traceability, IPC announced the availability of the following IP Reference Standards (IPRS):

Diethylene Glycol IPRS

Ethylene Glycol IPRS

Glycerin (Glycerol) IPRS

Propylene Glycol IPRS

Sorbitol IPRS

Maltitol (Mannitol Impurity B) IPRS

These standards can be accessed and purchased through the IPC’s online store at https://onlinestore.ipc.gov.in/jspui/products

Queries related to procurement can be addressed to sales-ipc@gov.in

Testing Guidance by IPC

The Commission has also issued a detailed guidance document —

IPC/GD/11: Testing of Diethylene Glycol and Ethylene Glycol in Liquid Orals by Gas Chromatography — providing validated protocols for laboratories conducting DEG and EG analysis.

Legislations and Government Advisories

The toolkit consolidates recent regulatory actions and advisories issued by the Government of India to strengthen quality compliance across the pharmaceutical supply chain:

CDSCO Advisory: Mandating strict compliance with the Drugs Rules, 1945 for testing both raw materials and finished formulations.

G.S.R. 922 (E): Notification on the Revised Schedule M, enhancing Good Manufacturing Practice (GMP) norms.

DGHS Advisory: On the rational use of cough syrups in paediatric populations.

CDSCO Advisory: Emphasizing the use of pharma-grade excipients in all formulations.

NABL-Accredited Labs List: Enumerating approved private testing laboratories authorized for testing cough syrups intended for export.

Supporting Global References

To promote harmonization with international standards, the IPC toolkit also includes:

• WHO TRS 1052, Annex 2: Good Manufacturing Practices (GMP) for Excipients.
• International Pharmacopoeia Test Method: For determining DEG and EG in oral liquid preparations.

To view the official document, click the link below: