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Updated July 2026

Pharma Guide · Buyer Checklist

6 Things to Check Before Choosing a Sterile Eye Drop Manufacturer in India

Eye drops are a sterile pharmaceutical preparation, manufactured to the same exacting cleanroom standard as injectables — not a lesser one. With over 500 WHO-GMP certified facilities in India (CDSCO, 2024-25), only a fraction operate the Grade A/B sterile cleanrooms ophthalmic manufacturing actually requires. Six specific checks separate genuine sterile capability from a claim.

  • 10 companies reviewed
  • WHO-GMP verified criteria
  • 14 min read

  • WHO-GMP Status

    Active cert — not expired

  • Sample COA

    real batch data, 24 hours

  • DCGI Approvals

    molecule-level approval

  • COPP on file

    for your target country

  • Grade A/B cleanroom

    sterile injectable

  • Written by

    Bhavya Bhambani

    Content Writer, 9M India

  • Reviewed by

    Manish Agrawal

    MD, 9M India Limited

  • Fact-checked by

    Manish Shah

    Plant Head, 9M India

About 9M India Limited — examples and standards referenced in this guide

9M India Limited is a WHO-GMP certified pharmaceutical manufacturer established in 2009, located in Birkoni, District Mahasamund, Chhattisgarh. The company operates a Grade A/B classified sterile manufacturing facility with a dedicated Water for Injection (WFI) system, producing ophthalmic formulations across 100+ DCGI-approved molecules. This guide uses 9M India’s documentation standards as the benchmark — COPP, FSC, COA, and stability data available within 24 hours, exports to 15+ countries.

Why these 6 checks matter — industry context

India’s ophthalmic pharmaceutical export sector reached approximately $450 million in FY2024 (Pharmexcil estimate, 2024). A verification challenge specific to eye drops: because they are liquid and appear simple, buyers frequently underestimate that ophthalmic manufacturing requires the identical Grade A/B sterile cleanroom and WFI water infrastructure as injectable manufacturing — not a lesser, liquid-appropriate standard. These six checks are the practical buyer’s verification framework, drawn from the documentation requirements of NAFDAC (Nigeria), MOH UAE, SFDA (Saudi Arabia), and WHO prequalification guidelines.

Cleanroom Grade

Confirm Grade A/B cleanroom classification — non-negotiable for sterile eye drop manufacturing

Cleanroom grade determines whether a facility can legally and safely manufacture sterile ophthalmic products. Grade C is insufficient.

#1 of 6

Eye drops require a Grade A classified aseptic filling zone with Grade B background environment — the identical standard required for sterile injectable manufacturing. Ask directly: “What cleanroom grade is your ophthalmic filling area classified at?” A vague answer is a disqualifying signal.

Cleanroom grade requirements for ophthalmic manufacturing

Cleanrooms are classified under EU GMP Annex 1 and WHO GMP guidelines by airborne particle counts and microbial contamination limits. For eye drops, Grade A is mandatory at the point of fill; Grade B is mandatory as the surrounding environment.

How to verify - step by step

  • Ask for cleanroom validation reports: Request the particle count study and environmental monitoring data directly.

  • Confirm Grade A at the fill zone specifically: Not just “clean” manufacturing — the exact classification at the point of fill.

  • Check for ongoing environmental monitoring: Viable and non-viable particle counts should be a continuous programme, not a one-time validation

  • Ask for EU GMP Annex 1 compliance documentation: This is the reference standard cleanroom classifications are measured against.

Cleanroom Grade Use in Ophthalmic Manufacturing Required for Sterile Eye Drops
Grade A Aseptic fill zone — direct product exposure Mandatory for fill zone
Grade B Background surrounding Grade A Mandatory — surrounds Grade A
Grade C/D Support areas, gowning, preparation Support areas only
No classification General non-sterile manufacturing Cannot produce sterile eye drops

Why this check matters for export

Import regulatory authorities specifically require documented Grade A/B validation for sterile ophthalmic drug registration — a facility without it cannot demonstrate compliance regardless of other claims. (WHO Technical Report Series No. 1044, Annex 1)

Red flags to watch for

Manufacturer cannot produce cleanroom validation documentation · Claims WHO-GMP but cannot confirm Grade A/B classification specifically · No ongoing environmental monitoring programme · Vague or evasive answers about fill-zone classification

From Industry Rankings

See how the top 10 eye drop manufacturers in India compare on sterile cleanroom status

Our editorial ranking compares the top 10 eye drop manufacturers in India across all 6 criteria in this guide — cleanroom grade, WFI water system, WHO-GMP ophthalmic scope, DCGI approvals, COA completeness, and export track record.

See the full ranking

WFI Water System

Confirm a WFI (Water for Injection) system — not standard purified water

The single most overlooked infrastructure gap in ophthalmic manufacturing is water quality — not the cleanroom.

#2 of 6

Sterile eye drop manufacturing requires Water for Injection (WFI) quality water for the aqueous formulation — a specially purified and continuously monitored water standard, meaningfully more rigorous than standard purified water used in non-sterile manufacturing.

Why WFI is a critical, not cosmetic, requirement
A manufacturer using standard purified water instead of WFI for ophthalmic products is not meeting WHO-GMP sterile requirements — full stop. This is a critical deficiency that can be difficult to detect without asking directly, since the finished product may look identical either way.

How to verify — step by step

  • Ask directly: “What water system do you use for ophthalmic formulation?” The answer should be WFI, specifically, not “purified water” or “RO water”.

  • Request WFI system validation data: Continuous monitoring records for conductivity, TOC, and bioburden.

  • Confirm WFI generation method: Typically distillation or reverse osmosis with appropriate validation per pharmacopoeial standards.

  • Cross-check against the cleanroom validation: WFI system and Grade A/B cleanroom should be part of the same sterile manufacturing validation package.

Why this check matters for export
Import regulators may specifically request water system validation data as part of a sterile product dossier — the absence of a documented WFI system is a common cause of query during registration review.

Red flags to watch for

Manufacturer cannot specify WFI system explicitly when asked · Only “purified water” or general “RO water” mentioned · No water system validation data available on request · WFI system claimed but not reflected in cleanroom validation documentation

WHO-GMP Certification

Confirm WHO-GMP certificate scope explicitly covers sterile ophthalmic manufacturing

A facility WHO-GMP certified for oral solid dosage forms is not automatically certified for sterile ophthalmic products.

#3 of 6

WHO-GMP certifies the facility, but the certification scope is specific to the dosage forms inspected and approved. Some facilities hold WHO-GMP for tablets or capsules only. Ask for the certificate and check the stated scope line explicitly before assuming ophthalmic coverage.

What is WHO-GMP certification in India?
WHO-GMP is issued by CDSCO following on-site inspection against World Health Organization Good Manufacturing Practice guidelines, and is time-limited, requiring periodic re-inspection. For sterile ophthalmic products specifically, the inspection additionally validates cleanroom classification and water systems covered in Checks 1 and 2 above.

How to verify — step by step

  • Request the actual certificate document: On CDSCO letterhead, with authorised signature and stamp.

  • Check the scope line explicitly: It should list ophthalmic or sterile products specifically, not just general manufacturing.

  • Check the expiry date: Certificates are time-limited and require periodic re-inspection.

  • Cross-verify on the CDSCO database: At cdsco.gov.in using the manufacturer’s licence number.

Why this check matters for export

NAFDAC, MOH UAE, and SFDA require the submitted WHO-GMP certificate to explicitly cover the dosage form being registered — a general facility certificate without sterile ophthalmic scope will not satisfy this requirement.

Red flags to watch for

Certificate scope lists only oral solid dosage forms · Manufacturer assumes ophthalmic coverage without showing the scope line · Certificate older than 3 years without re-inspection documentation · Cannot provide certificate within 24 hours

From the Compare section

WHO-GMP vs ISO 9001 — does certification type affect sterile COA quality?

Sterility and particulate matter testing are pharma-specific standards that only WHO-GMP covers. An ISO 9001 certified facility may not run these tests to pharmacopoeial method for ophthalmic products at all.

Complete COA
WHO-GMP certified facility

Sterility · Bacterial endotoxin · Particulate matter · Assay · pH — all required and documented per WHO-GMP batch release procedure.

  • All tests mandatory for batch release
ISO 9001 only facility

Sterility · Bacterial endotoxin · Particulate matter · Assay · pH — all required and documented per WHO-GMP batch release procedure.

  • Pharma-specific tests not mandated
Read Full Comparison

DCGI Approval

Confirm DCGI approval at the molecule level for your specific ophthalmic formulation

Ophthalmic DCGI approvals are combination-specific — Dorzolamide+Timolol is a distinct approval from either molecule alone.

#4 of 6

The DCGI manufacturing licence for ophthalmic products is molecule and formulation-specific. A manufacturer approved for one anti-glaucoma molecule is not automatically approved for a combination formulation containing that same molecule.

Why this matters more for eye drops than most dosage forms
Ophthalmic combination products — particularly anti-glaucoma fixed combinations — are common, and each combination requires its own DCGI approval. Some anti-glaucoma molecules may also carry additional controlled-substance import requirements in certain markets, adding a further layer to verify.

How to verify — step by step

  • Request the DCGI licence for your exact formulation: Combination or single-molecule, strength-specific.

  • Confirm combination approval separately if applicable: Individual molecule approvals do not cover the combined formulation.

  • Check for controlled-substance import flags: Particularly relevant for certain anti-glaucoma molecules in specific markets.

  • Verify preservative-free vs multi-dose approval if relevant: These may carry distinct approval requirements.

Why this check matters for export
Import regulators check the DCGI licence against the exact formulation filed in the dossier — a mismatch between an individually-approved molecule and an unapproved combination is a common cause of registration query.

Red Flags to Watch For

Manufacturer shows individual molecule approval for a combination product request · No clarity on controlled-substance status for anti-glaucoma molecules · DCGI licence doesn’t specify preservative-free vs multi-dose formulation · Approval details don’t match your exact strength

Certificate of Analysis

Request a sample COA with sterility and particulate matter results included

A COA missing sterility data for an eye drop product is not incomplete — it's disqualifying.

#5 of 6

For eye drops, the Certificate of Analysis must show a sterility test result, sub-visible particulate matter counts, and pH within ophthalmic tolerance range — parameters unique to sterile liquid products that a general COA template may omit.

What a complete ophthalmic COA must contain
Beyond assay, ophthalmic COAs require sterility, bacterial endotoxin (for aqueous formulations), particulate matter, and pH data — the same rigor applied to injectable products, since eye drops are administered to a mucous membrane under the same sterility principle.

How to verify — step by step

  • Request a real sample COA: From an actual recent batch, not a template.

  • Confirm sterility result is included explicitly: Pass/fail against BP or USP sterility method.

  • Check for particulate matter and pH data: Both should show actual numerical results.

  • Verify preservative content for multi-dose products: Confirms preservative efficacy is being tested, not assumed.

Why this check matters for export
Import regulators treat a COA missing sterility or particulate matter results as incomplete for dossier submission — this is one of the fastest ways to identify a manufacturer not genuinely equipped for sterile ophthalmic production.

Red Flags To Watch For

COA not available within 24 hours · Sterility result missing from the COA · Particulate matter or pH data absent · COA shows only pass/fail without numerical values

Export References

Ask for export references and COPP specifically for ophthalmic products in your target country

A manufacturer's broad export claims mean little if none of it covers ophthalmic products specifically.

#6 of 6

A Certificate of Pharmaceutical Product (COPP) confirms a specific product is authorised for manufacture and sale in India. Confirm the manufacturer’s COPP and export history covers ophthalmic products specifically — not just their broader product range.

What is a COPP (Certificate of Pharmaceutical Product)?
A COPP is issued under the WHO Certification Scheme by CDSCO for products manufactured by a DCGI-licensed manufacturer at a WHO-GMP certified facility. For ophthalmic products, an existing COPP covering your exact molecule and formulation can reduce registration timelines by 6–12 months. (WHO Technical Report Series No. 986, Annex 10)

How to verify — step by step

  • Ask “Have you previously exported ophthalmic products to [country]?” — specifically, not general export history.

  • Ask “Do you hold an active COPP for this ophthalmic product in [country]?” — confirm it covers your exact molecule.

  • Ask about controlled-substance handling experience: Particularly for anti-glaucoma exports.

  • Request a CTD or ACTD dossier if available: Export-experienced manufacturers typically hold ready dossiers.

Why this check matters for export
Anti-glaucoma molecules may carry additional controlled-substance import requirements in some markets — confirm the manufacturer’s export experience covers this complexity, not just simpler antibiotic eye drop registrations.

Red Flags To Watch For
General export claims without ophthalmic-specific references · No COPP covering your exact ophthalmic molecule · No experience with controlled-substance import requirements for anti-glaucoma products · Cannot name a specific ophthalmic product previously registered

More Pharma Guide

Frequently asked questions

  • How do I verify a WHO-GMP certificate covers sterile ophthalmic manufacturing?

    Request the actual certificate and check the scope line explicitly lists ophthalmic or sterile products — a general facility certificate for oral solid dosage forms does not automatically cover eye drops.

    Reference: Central Drugs Standard Control Organisation (CDSCO)

  • Why do eye drops need the same cleanroom grade as injectables?

    Eye drops are applied directly to a mucous membrane and must be free from viable microorganisms and sub-visible particles, exactly like an injectable. WHO-GMP applies the identical Grade A/B cleanroom requirement — there is no lower sterile standard for eye drops.

  • What should an eye drop Certificate of Analysis contain?

    A complete COA must include sterility test result, bacterial endotoxin result (for aqueous formulations), particulate matter counts, pH, assay, and preservative content — with actual numerical values, not just pass/fail.

    British Pharmacopoeia 2024

  • What is the difference between multi-dose and preservative-free eye drops?

    Multi-dose bottles contain a preservative to prevent contamination after opening. Preservative-free unit-dose formats require Blow-Fill-Seal packaging and suit patients with preservative sensitivity. Confirm your manufacturer’s capability matches the format you need.

  • How long does it take to get a COPP for an ophthalmic product from India?

    A fresh COPP application typically takes 30–90 days. Manufacturers with prior ophthalmic export experience to a specific country typically hold active COPPs providable within 24–48 hours.

    WHO Technical Report Series No. 986, Annex 10

9M India — passes all 6 checks

Ready to verify 9M India against your checklist?

WHO-GMP certificate, DCGI approval, sample COA, COPP, stability data — all available within 24 hours of your first enquiry.

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WHO-GMP certified · DCGI approved · 15+ export countries · Birkoni, Chhattisgarh · Est. 2009

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