CDSCO Renews Push for ONDLS Registration of Pharmaceutical-Grade Solvent – But Questions Remain

On 27 October, CDSCO issued a circular directing State Drug Controllers to ensure that vendors supplying “pharmaceutical-grade” solvents register on the ONDLS portal. Vendors are also required to upload distribution details and Certificates of Analysis (CoAs) for supplied materials. The circular further states that no batch of pharmaceutical-grade solvent should be distributed without obtaining a system-generated NOC.

This is not a new requirement. CDSCO had issued a similar communication in October 2025 following concerns arising from incidents involving Diethylene Glycol (DEG)-contaminated cough syrup and the resulting focus on supply chain integrity for high-risk pharmaceutical solvents / excipients such as propylene glycol, glycerin, sorbitol.

On the same date, CDSCO issued another circular directing State Drug Controllers to ensure quality testing of drug products and raw materials by licensed manufacturers. This too appears to be a reiteration of an earlier communication issued in October 2025.

The objective behind these measures is commendable. The ONDLS framework seeks to create greater traceability, digital monitoring, and accountability across the supply chain of high-risk pharmaceutical ingredients.

However, the notifications also raise an interesting regulatory question: what exactly constitutes a “pharmaceutical-grade” solvent under Indian law?

The Drugs & Cosmetics Act does not expressly define the term “pharmaceutical-grade solvent.” While CDSCO’s intent is clear, the statutory basis for enforcing such a requirement may warrant further clarification.

Section 3(b) of the Drugs & Cosmetics Act, defines a “drug” to include substances intended for use as components of a drug. Further, the Second Schedule requires drugs included in the Indian Pharmacopoeia to comply with the standards prescribed therein. So is the logic that solvents and excipients intended for pharmaceutical use and included in Indian Pharmacopeia be effectively considered as “pharmaceutical grade.”

Yet such an interpretation is not clear from the notifications. Questions therefore remain:

• Does the requirement apply only to pharmacopoeial-grade solvents?
• Would suppliers of excipients not covered by a pharmacopoeial monograph fall within its scope?
• Is the ONDLS registration requirement enforceable solely through an administrative circular, or does it require a more explicit statutory or regulatory foundation?
• How would enforcement be approached where the status of a material as “pharmaceutical grade” is defined?

Greater regulatory clarity, however, would help ensure consistent implementation and reduce uncertainty for both manufacturers and suppliers.

As India continues to strengthen oversight of pharmaceutical regulatory oversight, clearer definitions and an explicit legal framework will be as important as the digital systems designed to monitor them.

• CDSCO Notification: Digital Monitoring System on the ONDLS portal for Pharmaceutical Solvents
• CDSCO Notification: Testing of raw materials and finished formulations – Compliance