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Is Zerodol-SP banned in India?

Last checked 19 September 2026. A few details are still being checked against the original document.

Zerodol-SP. Status: Not banned · watch list.
No current action

Zerodol-SP is not banned in India as of 19 Sep 2026; the serratiopeptidase combinations prohibited so far are with etodolac + paracetamol and cephalexin (2024) and with amoxicillin or cefuroxime (11 Jun 2026).

Classification
No ban or recall found in official records
Decided by
CDSCO / Ministry of Health and Family Welfare
Reference
No Section 26A notification for aceclofenac + paracetamol + serratiopeptidase
Latest action
11 June 2026
Last checked
19 September 2026details being verified
See the source Report a mistake

Indian aceclofenac + paracetamol + serratiopeptidase tablet pack. Photo: Tainac-sp.jpg by Taionremedies (CC BY-SA 4.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.

Primary government sourceTier 1: government primary source

CDSCO: List of prohibited FDC drugs, 156 FDCs dated 02.08.2024

CDSCO / Ministry of Health and Family Welfare · No Section 26A notification for aceclofenac + paracetamol + serratiopeptidase · 2 August 2024

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Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.

Key facts

Governing authority
CDSCO, Ministry of Health and Family Welfare
Ban notification
None for this combination
Banned serratiopeptidase FDCs
Etodolac + PCM + serratiopeptidase; cephalexin + serratiopeptidase (2 Aug 2024); amoxicillin/cefuroxime + serratiopeptidase (11 Jun 2026)
Rumoured review
'34 more FDCs under review', no primary source found (being verified)
Manufacturer
Ipca Laboratories

Where the claim comes from

Two triggers. The 2 Aug 2024 list banned etodolac + paracetamol + serratiopeptidase, an FDC that looks like Zerodol-SP on a news list. Then on 11 Jun 2026 the ministry banned amoxicillin + serratiopeptidase and cefuroxime + serratiopeptidase, and headlines about 'serratiopeptidase combinations banned' were read as covering every product with the enzyme. A claim that 34 more FDCs are under review circulates without a primary source.

Zerodol-SP adds serratiopeptidase, an enzyme marketed for swelling, to aceclofenac and paracetamol. It is a heavily prescribed post-injury and dental painkiller, and it is not banned in India as of 19 September 2026.

The reason people ask is that the regulator has been steadily removing serratiopeptidase combinations. The 156-FDC notification of 2 August 2024 prohibited etodolac + paracetamol + serratiopeptidase and cephalexin + serratiopeptidase. The 16-FDC notification of 11 June 2026 prohibited amoxicillin + serratiopeptidase (S.O. 3072(E)), cefuroxime + serratiopeptidase (S.O. 3083(E)) and two related antibiotic-enzyme products. In each case the ministry's stated ground was the absence of therapeutic justification for the combination.

Aceclofenac + paracetamol + serratiopeptidase has not been named in any of these orders, nor in the April 2025 list of 35 unapproved combinations. Brands such as Zerodol-SP and Hifenac-SP remain licensed.

We have seen reports that a further 34 combinations are under review. We could not find a primary source for that number and have flagged it; it should not be repeated as fact. The honest description of Zerodol-SP is "not banned, but in a class the regulator is watching". If you use it long-term, it is reasonable to ask your doctor whether the enzyme component adds anything for you.

What this means for you

It can be sold and prescribed

No order restricts Zerodol-SP or Hifenac-SP as of today.

The class is under scrutiny

Regulators have removed four serratiopeptidase combinations since 2024. If that extends to this one, we will update the page.

This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.

Batches flagged in CDSCO alerts

No NSQ batch on record. No product matching this name appears in CDSCO or state-lab NSQ alerts from Jan 2019 to July 2026. Absence from the alerts is not proof of quality, check your batch number.

Official sources and primary records

Researched and written by The Blacklisted team
We are not doctors or pharmacists. Everything on this page comes from the documents listed above, which you can open and check. Last checked 19 September 2026. 2 details are still being confirmed against the original. Spotted a mistake? Tell us.