The CDSCO high-risk solvents monitoring 2026 update introduces mandatory registration and batch-wise data reporting requirements for manufacturers and suppliers of specified pharmaceutical-grade solvents. According to the communication dated 27 October 2026, the Central Drugs Standard Control Organisation (CDSCO) has directed stakeholders to use the Online National Drug Licensing System (ONDLS) portal for digital monitoring of the supply chain.
The directive aims to strengthen supply chain traceability, improve quality oversight and ensure that the required documentation and system-generated No Objection Certificate (NOC) are obtained before distributing covered batches.
CDSCO High-Risk Solvents Monitoring 2026
| Particular | Details |
|---|---|
| Regulatory authority | Central Drugs Standard Control Organisation (CDSCO) |
| Ministry/Department | Directorate General of Health Services, Government of India |
| Notification date | 27 October 2026 |
| Reference number | F. No. IT/ONDLS/MFG/Exp/2025/003 |
| Online portal | Online National Drug Licensing System (ONDLS) |
| Monitoring system | Digital Monitoring System (DMS) |
| Main requirement | Registration and batch-wise data upload |
| Distribution requirement | System-generated NOC before batch distribution |
| Intended stakeholders | Manufacturers and vendors/suppliers of covered pharmaceutical-grade solvents |
What Is the Latest CDSCO Notification About?
CDSCO has established a Digital Monitoring System on the ONDLS portal to monitor the supply chain and quality parameters of specified high-risk pharmaceutical solvents and excipients.
The communication dated 27 October 2026 continues an earlier communication dated 22 October 2025. The earlier letter referred to concerns about cough syrup contamination involving diethylene glycol (DEG) and described the need for stronger monitoring of pharmaceutical-grade solvents.
The latest communication asks State and Union Territory Drug Controllers to ensure that relevant manufacturers and suppliers comply with the portal requirements.
List of High-Risk Solvents Under CDSCO Monitoring
The annexure attached to the notification lists the following materials.
| S. No. | High-risk solvent or excipient |
|---|---|
| 1 | Glycerin |
| 2 | Propylene Glycol |
| 3 | Maltitol and Maltitol Solution |
| 4 | Sorbitol and Sorbitol Solution |
| 5 | Hydrogenated Starch Hydrolysate |
| 6 | Polyethylene Glycol (MW <1000) |
| 7 | Diethylene Glycol Stearates |
| 8 | Polyethylene Glycol Monomethyl Ether (certain low molecular weights) |
| 9 | Polysorbate 20/40/60/80, Polyoxyl 15 Hydroxystearate, Polyoxyl 20 Cetostearyl Ether, Polyoxyl 8 Stearate, Octoxynol 9 and Nonoxynol 9 |
| 10 | Ethyl alcohol |
Important: This list follows the wording of the notification’s annexure. Refer to the official document for the exact scope and applicable requirements.
What Are the Mandatory Requirements for Manufacturers and Suppliers?
1. Mandatory ONDLS Registration
Manufacturers and vendors/suppliers dealing with the specified pharmaceutical-grade solvents must register on the ONDLS portal.
According to the earlier communication dated 22 October 2025, manufacturers who already hold a manufacturing licence must register on the portal and submit the required information through the “Old Licence Management” facility.
2. Batch-Wise Data Upload
Manufacturers and suppliers must upload the information requested through the Digital Monitoring System.
The notification identifies the following information:
- Total quantities manufactured.
- Batch-wise manufacturing and supply data.
- Certificates of Analysis (CoA).
- Quantities supplied.
- Vendor credentials.
- Complete onward distribution details.
Stakeholders should ensure that the information submitted is complete and consistent with the relevant batch records.
3. System-Generated NOC Before Distribution
The 27 October 2026 communication states that no batch of the covered pharmaceutical-grade solvents should be distributed without uploading the required information on the DMS and obtaining the system-generated NOC.
Manufacturers and suppliers should therefore complete the required portal formalities before distributing a covered batch.
4. Compliance Across Manufacturing and Supply Units
The notification directs State and Union Territory Drug Controllers to ensure compliance within their jurisdictions. It also asks stakeholders to accord high priority to implementation across manufacturing and supply units.
Why Has CDSCO Introduced Digital Monitoring?
The earlier CDSCO communication dated 22 October 2025 referred to reports of cough syrup contamination involving diethylene glycol (DEG).
The digital monitoring system is intended to improve oversight through better documentation and supply chain traceability.
Its stated monitoring-related requirements include:
- Recording batch-wise information.
- Maintaining Certificates of Analysis.
- Documenting quantities manufactured and supplied.
- Recording vendor details and onward distribution.
- Obtaining a system-generated NOC before distribution.
These measures are intended to support regulatory oversight of pharmaceutical-grade materials used in drug manufacturing.
Who Needs to Follow These Requirements?
The communication is directed to State and Union Territory Drug Controllers, who have been asked to direct the relevant manufacturers and suppliers to comply.
| Stakeholder | Requirement described in the notification |
|---|---|
| Manufacturers of covered pharmaceutical-grade solvents | Register on ONDLS and upload the required data |
| Existing licence holders | Use the “Old Licence Management” facility, as described in the earlier communication |
| Vendors and suppliers | Complete applicable registration and provide the required supply and distribution information |
| State/UT Drug Controllers | Direct relevant stakeholders to comply within their jurisdictions |
Eligibility, age limit, vacancies, salary and selection process: Not mentioned in the official notification. This is a regulatory compliance update, not a recruitment advertisement.
How to Complete the ONDLS Compliance Process
The notification identifies the following compliance steps:
- Register on the ONDLS portal.
- If already holding a manufacturing licence, follow the earlier communication’s instructions for the “Old Licence Management” facility.
- Upload the required batch-wise data.
- Provide the applicable CoA, quantity, vendor and distribution details.
- Ensure the required information is uploaded to the Digital Monitoring System.
- Obtain the system-generated NOC before distributing a covered batch.
For portal-specific instructions, refer to the user guidance document available on the ONDLS website. The detailed click-by-click registration process is not mentioned in the official notification.
Important Dates and Reference Details
| Particular | Details |
|---|---|
| Earlier communication | 22 October 2025 |
| Latest communication | 27 October 2026 |
| Reference number | F. No. IT/ONDLS/MFG/Exp/2025/003 |
| Compliance deadline | Not mentioned in the official notification |
| Application start date | Not applicable; this is a regulatory compliance update |
| Official portal | ONDLS portal |
Contact Details for Technical Assistance
The latest communication provides the following email addresses for technical difficulties or system-related queries:
The earlier communication dated 22 October 2025 also listed the following contacts:
Stakeholders should verify the applicable contact details and current instructions before sending queries.
Important Links
| Resource | Link |
|---|---|
| CDSCO official website | https://cdsco.gov.in/ |
| ONDLS portal | https://ondls.cdscoservices.in/ |
Note: Confirm the availability of the relevant notification and portal guidance on the official websites before relying on the links for compliance.
Frequently Asked Questions (FAQs)
1. What is the latest CDSCO update on high-risk solvents in 2026?
CDSCO issued a communication dated 27 October 2026 directing manufacturers and suppliers of specified high-risk pharmaceutical-grade solvents to register on ONDLS and upload the required batch-wise information.
2. What is the ONDLS portal?
ONDLS stands for Online National Drug Licensing System. The notification describes its Digital Monitoring System as a platform for monitoring the supply chain of specified high-risk pharmaceutical solvents and related materials.
3. Which high-risk solvents are listed in the CDSCO notification?
The annexure lists glycerin, propylene glycol, maltitol, sorbitol, hydrogenated starch hydrolysate, specified polyethylene glycol materials, diethylene glycol stearates, specified polyoxyl compounds and ethyl alcohol, among other named materials.
4. Is ONDLS registration mandatory for covered manufacturers and suppliers?
Yes. The communication directs manufacturers and vendors/suppliers dealing with the covered pharmaceutical-grade solvents to register on the ONDLS portal.
5. What information must be uploaded to the Digital Monitoring System?
The notification specifies batch-wise data, total quantities manufactured, Certificates of Analysis, quantities supplied, vendor credentials and complete onward distribution details, as applicable.
6. Is an NOC required before distributing a covered batch?
Yes. The 27 October 2026 communication states that the required information must be uploaded to the DMS and the system-generated NOC obtained before distribution.
7. What is the last date for ONDLS registration?
A specific registration deadline is not mentioned in the official notification. The communication instructs stakeholders to complete registration immediately.
8. Where can stakeholders get technical assistance for ONDLS?
The latest communication lists ithelpdesk.statedrugs@cdsco.nic.in and it-cell@cdsco.nic.in for technical difficulties and system-related queries.
Conclusion
The CDSCO high-risk solvents monitoring 2026 update reinforces digital oversight of specified pharmaceutical-grade solvents through the ONDLS portal. The principal requirements include registration, batch-wise data submission, documentation of supply chain details and obtaining the system-generated NOC before distribution.
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