Ensuring Safety and Compliance: Mak Kemikal’s DRAP-Compliant Excipients for Oral Liquid Preparations
The Drug Regulatory Authority of Pakistan (DRAP) has recently issued an important advisory (dated 14th October 2025) to all therapeutic goods manufacturers, emphasizing preventive measures against Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination in oral liquid preparations such as cough syrups.
This advisory comes ahead of the winter season, a time when the production and demand for oral liquid formulations significantly increase. It highlights the urgent need for strict quality assurance, vendor qualification, and GMP compliance to protect public health and ensure pharmaceutical quality standards across Pakistan.
Understanding the DRAP Advisory
According to the official notification, all therapeutic goods manufacturers are required to:
- Procure Glycerin, Sorbitol, and Propylene Glycol only from qualified and approved vendors/manufacturers.
- Perform mandatory pre-use testing for DEG and EG impurities in all procured batches prior to use.
- Maintain complete documentation and traceability through Batch Manufacturing Records (BMRs).
- Verify Certificates of Analysis (CoAs) and ensure compliance with current Good Manufacturing Practices (cGMP).
Non-compliance with these directives may result in strict regulatory action under the Drugs Act, 1976 and DRAP Act, 2012.
Mak Kemikal’s Commitment to Quality and Compliance
At Mak Kemikal, we fully support and comply with DRAP’s mission to ensure patient safety and product quality.
Our excipient range — including Glycerin (Pharma Grade), Sorbitol (Pharma Grade), and Propylene Glycol (USP/Ph. Eur. Grade) — meets the highest international standards and is sourced only from qualified global manufacturers with validated quality systems.
Every batch supplied by Mak Kemikal is accompanied by:
- Comprehensive Certificates of Analysis (CoA) verifying purity and quality parameters.
- Batch traceability documentation in line with BMR requirements.
- Regulatory support and technical assistance for compliance verification and product validation.
As The Excipient Company, Mak Kemikal remains a trusted partner to Pakistan’s leading pharmaceutical and nutraceutical manufacturers. We provide not only high-quality excipients but also the confidence of regulatory compliance.
Our goal is to help manufacturers meet DRAP requirements with ease by ensuring the availability of verified, compliant, and ready-to-use raw materials — minimizing risk and maximizing reliability in production.
Stay compliant. Stay confident.
Choose Mak Kemikal for verified, safe, and DRAP-compliant excipients that support the highest standards of pharmaceutical manufacturing.