India supplies approximately 20% of the world’s generic medicines by volume, making it the largest provider of affordable pharmaceuticals globally. However, for international buyers — whether patients sourcing personal medication or procurement professionals building supply chains — the question of quality assurance is paramount. This guide walks through the concrete steps you can take to verify the quality and authenticity of Indian generic medicines before making a purchase.
🔍 Step 1: Check CDSCO Manufacturing License (Form 25/28)
Every pharmaceutical manufacturer in India must hold a valid manufacturing license issued by the Central Drugs Standard Control Organisation (CDSCO) or the relevant State Drug Control Authority. These licenses are issued in the form of Form 25 (for manufacturing drugs other than those specified in Schedule C and C1) or Form 28 (for Schedule C drugs like injectables and vaccines).
How to verify:
- Ask the manufacturer or distributor for their CDSCO license number and state-level drug license number.
- Cross-check against the CDSCO’s online database at
https://cdscoonline.gov.in(the “Approved Drug Manufacturers” search). - Verify that the manufacturing address on the license matches the actual production facility — not just a registered office.
- Check the expiry date of the license — expired licenses mean the facility is not currently authorized to manufacture.
As reported by Medical Dialogues (November 2025), CDSCO routinely conducts quality testing of drug samples across states, and in October 2025 alone, 148 medicine samples failed CDSCO quality tests. This underscores why checking the manufacturer’s regulatory standing is a critical first step — not all licensed facilities maintain consistent quality.
🏭 Step 2: Verify WHO-GMP Certification
WHO-Good Manufacturing Practices (WHO-GMP) certification indicates that a manufacturing facility meets the World Health Organization’s international standards for quality production. In India, the revised Schedule M (aligned with WHO-GMP standards) came into effect in stages, with the DCGI issuing directives for full enforcement by January 2026 following the contaminated cough-syrup incidents that drew global scrutiny.
Key points about WHO-GMP for Indian manufacturers:
- WHO-GMP is not a single permanent certification — it must be renewed periodically (typically every 2-3 years) after facility re-inspection.
- A WHO-GMP certificate lists the specific manufacturing areas and product types it covers. A certificate for tablets does not automatically cover injectables.
- Many Indian manufacturers prominently display their WHO-GMP certificate on their website. Check that the certificate number matches the WHO database or the issuing authority’s records.
- After the revised Schedule M implementation (2024-2026), manufacturing facilities must meet upgraded standards for HVAC systems, water purification, contamination control, and quality management systems — as highlighted in a BioSpectrum India analysis of the Schedule M changes.
If a manufacturer or exporter cannot produce a valid WHO-GMP certificate, consider this a red flag — especially for products destined for regulated markets like the EU, USA, or Australia.
🔬 Step 3: Verify Product-Specific Approvals
Even if a manufacturer holds a valid license and WHO-GMP certification, individual drug products also require specific regulatory approvals before they can be marketed in India or exported.
For Indian domestic sales: Each drug formulation must have a Drug Marketing Authorization (DMA) from CDSCO or the State Drug Authority. This is typically evidenced by a Form 46 (for drugs manufactured in India) or Form 46A (for imported drugs).
For exports: The manufacturer must hold a Certificate of Pharmaceutical Product (COPP), which is issued by CDSCO and attests that the product is manufactured in a facility meeting WHO-GMP standards. In July 2025, CDSCO extended the COPP application deadline for pharma units to August 15, 2025 via the Online National Drugs Licensing System (ONDLS), as reported by Business Standard — manufacturers transitioning to this system should have completed the migration.
Practical tip: Ask the supplier for a copy of the COPP for each specific product you intend to purchase. Cross-reference the product name, strength, and dosage form against the COPP. Generic products sometimes share certificates improperly — each distinct product should have its own or be clearly listed on a product schedule attached to the COPP.
🧪 Step 4: Independent Lab Testing and Batch Analysis
For bulk procurement or high-value purchases, independent third-party laboratory testing is the gold standard for quality verification.
- Request batch analysis certificates (CoA) — A Certificate of Analysis for each batch shows the actual test results for active pharmaceutical ingredient (API) content, dissolution rate, uniformity of weight, microbial limits, and impurity profile.
- Compare against pharmacopoeial standards — Indian generics should conform to the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), or United States Pharmacopeia (USP) standards, depending on the target market.
- Send samples to accredited labs — Independent labs such as SGS, Eurofins, or Intertek can perform full pharmacopoeial testing on submitted samples.
- Check for WHO prequalification — The WHO Prequalification Programme (WHO PQ) is a rigorous assessment of medicinal products. A product with WHO PQ status has passed stringent evaluation and is suitable for procurement by UN agencies and many national health programs.
🤝 Step 5: Work with Verified Distributors and Industry Bodies
One of the most reliable ways to avoid substandard medicines is to source through established, verified distributors rather than unknown online vendors.
The Indian Medicine Suppliers and Distributors Association (IMSDA) maintains a directory of member distributors who have been vetted for regulatory compliance and business legitimacy. For a list of verified and reliable pharmaceutical distributors, refer to the IMSDA’s verified member directory. IMSDA membership provides an additional layer of accountability — members are known to the association and subject to its code of conduct.
Additional verification resources:
- Pharmexcil (Pharmaceuticals Export Promotion Council of India) — Maintains a database of export-worthy Indian pharma companies. Visit
https://pharmexcil.orgto check if a manufacturer is registered. - Import alert databases — The US FDA maintains an import alert list (Red List) for companies with detected violations. Check the FDA online database before sourcing from unknown manufacturers.
- WHO Alert System — WHO issues medical product alerts for substandard and falsified medicines. Subscribe to their alerts.
✅ Checklist: Quick Quality Verification Before Purchase
- ✅ CDSCO/State manufacturing license verified (valid, non-expired, correct address)
- ✅ WHO-GMP certificate obtained and verified (covering the specific product type)
- ✅ Product-specific COPP or marketing authorization confirmed
- ✅ Certificate of Analysis for the batch provided and matched against pharmacopoeial standards
- ✅ Manufacturer is registered with Pharmexcil (for exports)
- ✅ No import alerts or FDA red-listing for the manufacturer or product
- ✅ Distributor is a known, verified entity (e.g., IMSDA member)
- ✅ Product packaging matches expected design, expiry date is more than 18 months away
- ✅ Shipment includes manufacturer invoice, packing list, and batch traceability documentation
For more information, contact IMSDA at contact@indiamedicine.org.