Certificate of Pharmaceutical Product (COPP) for Export from India

What is a Certificate of Pharmaceutical Product (COPP)?

A Certificate of Pharmaceutical Product (COPP) is an official document required for the export of pharmaceutical products from India. It certifies that the medicinal product is manufactured and approved for sale in India and complies with the WHO-GMP (Good Manufacturing Practices) guidelines.

📌 Issued By: Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India
📌 Regulated By: WHO-GMP (World Health Organization - Good Manufacturing Practices)
📌 Purpose: Ensures that the exported pharmaceutical product meets international quality, safety, and efficacy standards.
📌 Required For: Exporting medicines, vaccines, medical formulations, and pharmaceutical products

Who Needs a COPP?

✅ Pharmaceutical Manufacturers – Companies producing medicines and drugs for export.
✅ Pharmaceutical Exporters – Required for registration in the importing country.
✅ Medical & Healthcare Product Suppliers – Selling to international markets.
✅ Contract Manufacturing Organizations (CMOs) – Producing medicines for foreign clients.

Products Requiring COPP

🔹 Allopathic Medicines – Tablets, capsules, injections, syrups, ointments.
🔹 Ayurvedic & Herbal Medicines – Herbal formulations and nutraceuticals.
🔹 Vaccines & Biotech Products – Human and veterinary vaccines.
🔹 Medical Devices & Diagnostics – In some cases, as per importing country requirements.

How to Obtain a COPP?

📌 Apply through the CDSCO Online Portal: https://cdscoonline.gov.in

Application Process

1️⃣ Register with CDSCO – Obtain a WHO-GMP certificate first.
2️⃣ Submit Application Online – Provide product and manufacturer details.
3️⃣ Inspection by Drug Authority – CDSCO or State Drug Controller inspects the facility.
4️⃣ Laboratory Testing – Ensures product safety, efficacy, and compliance with WHO standards.
5️⃣ Approval & COPP Issuance – Certificate is granted after compliance verification.

Documents Required for COPP

📜 WHO-GMP Certificate – Mandatory for COPP application.
📜 Manufacturing License – Issued by the State Drug Authority.
📜 Product Registration Certificate – Proof of drug approval in India.
📜 Batch Release Certificate – For vaccines and biotech products.
📜 Quality Control & Testing Reports – From an approved laboratory.
📜 Details of the Importing Country – Regulatory requirements and product specifications.

Validity of COPP

🔹 Usually valid for 2-3 years, depending on the importing country’s requirements.
🔹 Must be renewed before expiry for continued exports.

Importance of COPP in Pharma Exports

✅ Mandatory for Drug Registration in Importing Countries
✅ Ensures Compliance with WHO-GMP Standards
✅ Builds Trust with International Buyers & Regulatory Authorities
✅ Facilitates Market Entry in Multiple Countries