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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO) has issued new directions for stringent controls on the supply chain of high-risk pharmaceutical-grade solvents. As per CDSCO directive dated 22 October, 2025, all high-risk Pharma grade solvent manufacturers shall obtain manufacturing license through the ONDLS portal. Solvent manufacturers should also update details of manufacture of each batch like quantity, batch certificate of analysis (COA), details of vendors to whom solvents are sold. The directive is applicable to solvents Glycerin, Polyethylene Glycol, Propylene Glycol, Polysorbate and others (see detailed list below). Furthermore, CDSCO has upgraded the ONDLS portal to support this digital monitoring and has requested all State Drug Controllers to ensure no batch is available in the market without complying to above direction.
Are we missing Key Issues?
While stringent monitoring and actions are necessary to prevent any more incidents like the Coldrif cough syrup fiasco, the question remains how such intervention will address the root cause of the contamination issue. The key issue that seems to be getting missed is that several of the cough syrup contamination related issues were not caused by solvents sourced from standard pharma grade solvent manufacturers. In almost all reported cases, the contamination was linked to the substitution of pharmaceutical-grade materials with spurious, recycled, or industrial-grade solvents adulterated with toxic contaminants like Diethylene Glycol (DEG) or Ethylene Glycol (EG). The new directive places a significant compliance burden on legitimate, pharma-grade manufacturers. It does little, however, to tackle the unscrupulous operators who supply / use the cheap, non-compliant, adulterated solvents.
Enforcement and Regulatory Challenges
Another key question is: How will CDSCO or state regulatory authorities ensure that cough syrup formulators are not using these spurious, contaminated substitutes? Is there a complementary directive mandating that drug manufacturers use solvents only from CDSCO-authorised or licensed solvent manufacturers? Is there a monitoring mechanism in place to track and enforce that all formulators, especially those producing cough syrups, use only solvents from licensed manufacturers?
The ambiguity is compounded by legal gaps as well. The Drugs and Cosmetics Act, 1940, India’s apex drug regulatory statute, do not define “Pharma Grade solvent.” It has only very broad definitions and requirements such as those given in Section 3 of Chapter I – definition of drug, Section 18 of Chapter IV- prohibition of manufacture and sale of certain drugs and cosmetics:
This raises fundamental questions about the norms and requirements to issue and enforce licenses specific to solvent manufacturers. The regulatory system already faces serious challenges in enforcing compliance even with well-defined requirements, such as Schedule M: Good Manufacturing Practices (GMPs), across the drug product and active pharmaceutical ingredient (API) sectors. Against this backdrop, the ability of drug regulatory authorities to effectively enforce control over an entirely new layer of the supply chain—pharmaceutical solvents – raises serious doubts.
It also doesn’t help that the CDSCO directive is vague on some of the operational factors. For instance, the “request” to State/UT Drug Controllers to ensure no batch is available in the market without compliance leads to ambiguity:
Are Drug Controllers and Inspectors now expected to have active surveillance over the entire solvent supply chain. India doesn’t even have a national level database of all approved drug products for quick reference. So are CDSCO / State drug regulators going to create and maintain a database of pharma grade solvents, manufacturers and supplies. How well the requirement of updating details of all batches of solvent manufactured going to be complied by Pharma grade solvent manufacturers.
The Bottom Line
What the Indian drug regulatory system requires is a comprehensive overhaul of the regulatory compliance monitoring and enforcement mechanism. It will take time and effort. Meanwhile urgent measures taken to address issues like the cough syrup contamination should also be comprehensive, implementable and address the key concerns and root causes. Cosmetic measures at the surface may achieve little material improvement, resulting only in a semblance of regulatory action while failing to protect public health.
List of High Risk Solvents and per CDSCO Directive on Pharma grade solvents
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