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Peethaambaran Kunnathoor, Chennai October 14 , 2025
In a direct and stringent response to the health crisis triggered by contaminated Coldrif cough syrup which resulted in the death of at least 21 children, Manali Petrochemicals Limited (MPCL) in Chennai, a key player in India’s solvent manufacturing sector, has issued sweeping new mandates for its propylene glycol IP (PG IP) product.

The move comes as the Indian pharmaceutical supply chain scrambles to restore confidence following the tragic incidents linked to diethylene glycol (DEG) contamination, a toxic substance that may be mistakenly substituted for or contaminate pharmaceutical-grade solvents.

As one of the three major domestic manufacturers of essential chemical intermediates, MPCL’s guidelines are focused on ensuring the integrity of the crucial PG IP, a solvent widely used in pharmaceutical preparations like oral liquids. The company’s official instruction sheet explicitly addresses distributors, dealers, and customers, indicating a zero-tolerance approach to quality control from factory gate to final use in manufacturing units. The core message is clear, every stage of the supply chain now requires forensic accountability.

The first critical instruction addresses receiving the product. All customers and dealers are now required to conduct a mandatory physical inspection of the PG IP barrels immediately upon receipt. This inspection is non-negotiable and must verify three critical attributes such as the colour of the material, the proper stencilling on the barrel, and, most importantly, the intact status of all tamper-proof seals. This physical check serves as the first line of defense against any potential adulteration or breach during transit.

Beyond initial verification, the instructions detail rigorous operational protocols. For sampling procedures, users must now employ a ‘thief catcher’ device and execute the entire process within a closed atmosphere to shield the product from external contamination. Furthermore, preservation guidelines mandate that samples be stored in suitable preservation bottles, preferably aluminium, and maintained at ambient temperature. These preserved samples are essential for future quality audits and traceability in case of any regulatory scrutiny.

On the commercial and regulatory front, MPCL has tightened its sales and disposal rules. Distributors are strictly prohibited from selling propylene glycol IP to any entity that does not possess a valid drug license for storage and sales. 

Additionally, the company is enforcing the rule that the solvent must be stored exclusively in a valid licensed warehouse. To prevent the future misuse of containers, there is also a clear directive requiring the immediate overpainting of all stencilled letters and printed content on empty barrels prior to disposal.

In a key step toward improving transparency with regulatory bodies, the company has also mandated that it be informed immediately if sampling of its product material is initiated by any government authority or institution. This step is designed to facilitate swift, cooperative response and minimize communication gaps during investigations, signalling an industry-wide push for better collaboration between manufacturers and state or central monitoring agencies during a crisis.

Ultimately, these stringent instructions underscore the serious nature of the task at hand for India's solvent manufacturers, completely eliminating the risk of toxic adulterants entering the pharmaceutical supply chain. For emergencies and general communications related to these new protocols, dealers and customers have been directed to contact the marketing department or the quality assurance head of Manali Petrochemicals Limited, ensuring that responsible points of contact are readily available to address compliance issues.

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