India's DEG and EG requirements for excipients come from several actions, not one rule. CDSCO and the DCGI have advised pharma-grade excipients from approved vendors and batch-wise testing. An Indian Pharmacopoeia amendment adds a limit of 0.10% each of DEG and EG for finished oral liquids, and CDSCO has reportedly begun tracking batch CoAs and vendors for high-risk solvents.
Why are DEG and EG a problem in excipients?
Diethylene glycol (DEG) and ethylene glycol (EG) are industrial glycols that are toxic when swallowed. Glycerine, propylene glycol, sorbitol and low-molecular-weight PEG are used as solvents and carriers in oral liquids. If an industrial glycol is substituted for one of them, or carried into it, it reaches the patient in the finished medicine.
The IPEC Europe position paper on DEG and EG, dated 27 April 2026, cites more than 300 deaths in 2022-25. In India at least 24 children died in the 2025 outbreak, according to published summaries, and several of the actions below came in the weeks after it.
The actions below tighten checks on excipient lots and their suppliers, not only on the finished syrup. Diethylene glycol and mono ethylene glycol (MEG) remain legitimate industrial chemicals, and Supreme Petro Chemicals lists both as such, but they are not interchangeable with pharmacopoeial excipients.
What has India required since 2023?
Indian action has come as advisories, orders, pharmacopoeial changes and one monitoring directive, not a single order. The table lists them by date, as reported in the sources at the foot of this page. Check each against the original document.
| Date | Authority | What it requires | Scope and status |
|---|---|---|---|
| 1 Jun 2023 | DGFT | Cough-syrup exports only after the export sample is tested at a government-earmarked laboratory, with a CoA | Exports of cough syrup. Notification number not found; current status not checked |
| Dec 2023 | CDSCO advisory | Buy and use only pharma-grade excipients from approved vendors | Advisory (RAPS report) |
| 7 Oct 2025 | DCGI advisory | Batch-wise testing of excipients, APIs and finished products under the Drugs Rules is mandatory | Reminder of an existing duty (Business Standard report) |
| 9 Oct 2025 | Himachal Drugs Controller | 100% sampling of all excipient containers plus all finished batches | State-level order (Tribune India report) |
| 10 Oct 2025 (list date) | Indian Pharmacopoeia Commission | IP 2022 Amendment List 09 adds a DEG and EG test by GC, NMT 0.10% each, to the Oral Liquids monograph | Finished oral liquids. Effective date not stated in the text read |
| 22 Oct 2025 | CDSCO | ONDLS directive F.No. IT/ONDLS/MFG/Exp/2025/003: manufacturers upload batch quantity, CoA and vendor lists for high-risk solvents | As reported by Medical Dialogues; CDSCO letter not checked |
| 15 Jan 2026 | Indian Pharmacopoeia Commission | Guidance IPC/GD/11 v2.0 on testing for DEG and EG | Non-mandatory guidance |
Four of these actions are dated between 7 and 22 October 2025. We found no 2026 Indian rule making DEG and EG testing of excipients statutory in its own right; the DCGI advisory frames batch testing as an existing duty under the Drugs Rules.
What limit does the Indian Pharmacopoeia set?
The Indian Pharmacopoeia Commission's (IPC) Amendment List 09 to IP 2022, dated 10 October 2025, adds to the Oral Liquids monograph a test for DEG and EG by gas chromatography (GC), with a limit of not more than 0.10% of each. This is a requirement on the finished oral liquid. It is not an excipient monograph limit, and we quote no excipient-specific DEG or EG number because our sources give none.
Two cautions. The text we read does not state when the change takes effect, and we have not confirmed how it carries into IP 2026 (released 2 January 2026, superseding IP 2022), so check the Oral Liquids monograph in the edition your QA system cites. And the Commission's guidance IPC/GD/11 v2.0 of 15 January 2026 on DEG and EG testing is non-mandatory.
IP is the official book of standards for drugs under the Second Schedule of the Drugs and Cosmetics Act 1940, and the Commission states that IP standards are legally enforceable. For how IP, BP and USP differ, see our guide to IP, BP and USP grade chemicals.
Which excipients are covered?
The CDSCO letter F.No. IT/ONDLS/MFG/Exp/2025/003 of 22 October 2025 is the authority on scope. A Medical Dialogues report says manufacturers are to upload batch quantity, CoA and vendor lists for high-risk solvents, and names glycerine, propylene glycol, sorbitol, maltitol, HSH (hydrogenated starch hydrolysates) and low-molecular-weight PEG. We have not seen the letter, so treat the list as reported, not verified. The table sets it beside other references from our sources.
| Excipient | In the reported ONDLS list | Other references in our sources |
|---|---|---|
| Glycerine | Listed | US FDA guidance of May 2023 covers glycerin |
| Propylene glycol | Listed | US FDA guidance of May 2023; the FSSAI compendium shows EG as "Absent" in its food-additive specification (INS 1520) |
| Sorbitol | Listed | Draft Ph. Eur. DEG and EG tests for liquid sorbitol, per IPEC Europe |
| PEG | Low-molecular-weight PEG, as reported; our sources do not say where "low" ends | None in our sources |
The reported list says only "low-molecular-weight PEG", and our sources do not define the range, so a buyer of PEG 4000 or PEG 6000 should not assume either way: read the letter or ask your regulatory affairs team.
What should a buyer ask the supplier for?
This is practical good practice, not legal advice. Items 1 to 5 are document and label checks, not tests, so they suit a small manufacturer without a full QC laboratory, whether the end product is a drug, a nutraceutical or a cosmetic.
- The producer's batch-specific CoA, not a trader's summary. It should name the monograph and edition tested against: IP, BP, or a USP-NF monograph with its official date, since USP-NF now dates each monograph separately.
- The DEG and EG result and method on that CoA, as a figure against a limit, not the word "complies".
- The original manufacturer's name and site, as the CoA states them, matching your vendor file.
- Vendor approval records: your own qualification file for supplier and producer. CDSCO's December 2023 advisory said to buy pharma-grade excipients only from approved vendors.
- Matching batch numbers on the drum, the CoA and the invoice, with manufacture and expiry or retest dates.
- A retained sample of every lot, for re-test. Whether and how your licence requires you to test each lot is a question for your QA and regulatory team; the DCGI advisory of 7 October 2025, as reported by Business Standard, described batch-wise testing of excipients as mandatory under the Drugs Rules.
The SDS answers a different question: it describes hazards, not batch quality (see how to read an SDS). Under the ONDLS directive the CoA is reportedly a document you may have to upload, so a CoA with gaps could become a regulatory-record problem as well as a QA one, if the reported upload requirement applies to you.
What changes in 2026?
Most 2026 movement we found is guidance and draft text; we found no new rule making excipient DEG and EG testing statutory.
- The IPEC Europe paper of 27 April 2026 also cites draft Ph. Eur. DEG and EG tests for liquid sorbitol and maltitol, and FDA guidance of May 2023 covering glycerin and propylene glycol.
- A draft dated 29 December 2025 would drop syrups from Schedule K. One report says it became the Drugs (Fifth Amendment) Rules 2026; that is not confirmed.
Not confirmed: the ONDLS excipient list (verify it against the CDSCO letter), the status of the DGFT export rule, effective dates for IP 2026 and the Amendment List 09 test, and any 2026 Indian rule making excipient DEG and EG testing statutory. We found none.
Likely to change: BP 2027 and Ph. Eur. issue 13.1 take effect on 1 January 2027, so check that the edition on each new CoA matches your specification. Watch for further IP 2026 amendment lists and for changes to the ONDLS list.
FAQ
What is the DEG limit in propylene glycol?
Our sources give no excipient-specific DEG figure for propylene glycol, so we quote none. The only numerical limit they give is the Indian Pharmacopoeia's NMT 0.10% each of DEG and EG, which applies to finished oral liquids. The FSSAI compendium shows EG as "Absent" for food-additive propylene glycol (INS 1520). Read the limit from the monograph you specify and confirm it on the producer's CoA.
Is DEG and EG testing of excipients mandatory in India?
The DCGI advisory of 7 October 2025 described batch-wise testing of excipients, APIs and finished products under the Drugs Rules as mandatory, a reminder of an existing duty. We found no 2026 rule adding a separate statutory DEG or EG test for excipients. Treat testing and supplier records as expected, and confirm the position for your product with your regulatory affairs team or licensing authority. This is not legal advice.
Which excipients are on the CDSCO ONDLS list?
As reported by Medical Dialogues: glycerine, propylene glycol, sorbitol, maltitol, HSH and low-molecular-weight PEG. The CDSCO letter of 22 October 2025 is the authority, and we have not verified the list against it.
Does an IP, BP or USP label prove a batch is free of DEG and EG?
No. A label is only a claim. What counts is the producer's batch CoA, citing the monograph and edition, showing the DEG and EG test, its method and the result, with a batch number that matches the drum. If the CoA shows no DEG and EG result, ask for it before the lot is used.
Do these rules apply to nutraceutical and cosmetic manufacturers?
The IP test sits in a drug monograph. The sources we used do not say how the ONDLS directive applies to nutraceutical or cosmetic manufacturers, so confirm with your licensing authority. The checklist above is sensible practice for any oral product.
Sources
- Indian Pharmacopoeia Commission, Amendment List 09 to IP 2022 (PDF).
- Indian Pharmacopoeia Commission, guidance IPC/GD/11 v2.0 on testing for DEG and EG (PDF).
- Indian Pharmacopoeia Commission, frequently asked questions (legal status of IP).
- Indian Pharmacopoeia Commission, release of IP 2026.
- Medical Dialogues, CDSCO ONDLS monitoring of high-risk solvents.
- Business Standard, export testing of cough syrups from 1 June 2023.
- RAPS, CDSCO advisory on pharma-grade excipients.
- Business Standard, DCGI advisory of 7 October 2025.
- Tribune India, Himachal Pradesh testing order.
- IPEC Europe, position paper on DEG and EG, 27 April 2026 (PDF).
- RAPS, draft Schedule K proposal.
- FSSAI, compendium, Chapter 3: substances added to food (PDF).
- USP, new USP–NF publication model.
- Swissmedic, Ph. Eur. implementation dates.
- British Pharmacopoeia, pharmacopoeia.com.
- Wikipedia, 2025 India cough syrup crisis (summary of the 2025 outbreak).
Where does Supreme Petro Chemicals fit, and how do I enquire?
Supreme Petro Chemicals is a trader, not a manufacturer. We supply glycerine, Glycerin USP, propylene glycol, sorbitol, PEG and other chemicals to manufacturers from Chennai. The DEG and EG result you rely on is the one on the producer's batch CoA, so ask for that CoA with your enquiry.
To enquire, use our contact page, WhatsApp Sanketh on +91 86087 80096, or email admin@supremepetrochemicals.com. Please state the product, the grade and standard with its edition, the quantity and the pack.
Last reviewed 3 October 2026. First published. Regulatory items rest on the sources listed, mostly secondary reports; items marked reported or not confirmed were not checked against the original document. Re-check this page after 1 January 2027.