Certificate of Pharmaceutical Products (COPP)

Introduction

In the highly regulated pharmaceutical industry, obtaining a Certificate of Pharmaceutical Product (COPP) is crucial for manufacturers looking to import, license, or market their pharmaceutical products in India. The COPP is a certification that ensures compliance with the Indian Medical Device Regulations set forth by the Central Drugs Standard Control Organization (CDSCO). This comprehensive guide will walk you through the step-by-step process of obtaining a COPP in India, including the necessary documents, eligibility criteria, fee structure, and the benefits of acquiring this certification.

The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of origin and also states that the manufacturer of the drug complies with GMP and that they are regularly inspected by the national health authorities

A CoPP is issued in the format which is recommended by WHO. It is the importing country which needs the CPP for the pharmaceutical product and a special type of certificate which allows the registration and marketing of a given pharmaceutical product in the exporting country of interest and forms sections of the application for marketing authorization. The CoPP is necessary when the drug is intended by the importing country for registration or renewal (licensing, authorization, or extension) for the scope of the product being sold or marketed in that country. A certificate has been recommended to assist the undersized drug regulatory authorities (DRA) or also without sufficient quality assurance (QA) facilities in WHO importing countries and also to determine the quality of pharmaceutical products according to import or registration requirements.

It is issued by the Inspectorate and the product supplier having GMP position and also the pharmaceutical, radiopharmaceutical, biological or veterinary drug status. The approved information is varied for various pharmaceutical formulations and strengths so it is often provided for a single product.

Objective of certification

A CoPP demonstrates that imported medication is of the relevant standard of quality, safety and efficacy to allow marketing, rigorous testing and inspection in the exporting country to be carried out by regulatory authorities and shows that it meets the relevant standards and procedures of Good Manufacturing Practice (GMP) and improves the product's quality and health.

Drugs for which COPP may be issued

• Approved drug products
• Active Pharmaceutical Ingredients (API)
• Over the counter (OTC) drug product
• Unapproved product
• Homeopathic drug

To increase business in a foreign country it is necessary to obtain the COPP certificates by the pharmaceutical company

Who Can Apply

• The person/company that exports the product must present a complete application for export certification.
• The qualification is intended for a drug that meets the criteria of the Act or the criteria of the Food Drug and Cosmetic Act.

Process of obtaining the certificate

1. Send Form No. 3613b – Located on the FDA internet www.fda.gov/downloads/AboutFDA/Reports ManualsForms / Forms / UCM052388b) CoPP approval requirements:

• Applicant Contact Information
• Trade name (brand name of the drug product) 
• Bulk Material Generic Name
•  Applicant's name
• Product License holder {List of manufacturing site on CPPP}
•  Full Manufacturing Facility Address
•  Facility Registration Number
• Countries importing
•  Permission to release details
•  Number of certificates required
•  Certification Statement
•  Marketing status in the exporting country

1. Additional information

Foreign manufactured drugs Export certification from the country for the Foreign Manufacturing sites Approved drug products NDA, ANDA, BLA or approval Letter / Outer Container Label(s) / Package Insert / Package Container (Immediate)

Guideline for COPP form attachments:

1. All attachments will be required in two sets
2. Attachments should not be more than 5 pager
3. Applicant should consult with importing country for different types of information

COPP is generally issued within20 working days from the date of application and issued certificate expires in 2 years from the date of notarization.

Stepwise process to apply for WHO - COPP

Before initiating the registration process, it is important to determine whether your medical device or pharmaceutical product falls under the category of notified medical devices. The Drugs and Cosmetics Act, 1940, and Rules, 1945, regulate the import, manufacturing, sale, and distribution of medical devices in India. Currently, 22 notified medical devices require registration with the CDSCO. These include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes and needles, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. However, this list is not exhaustive, and it is important to consult the CDSCO for the most up-to-date information on notified medical devices.

Step 2: Appoint an Authorized Indian Agent

According to Indian regulations, foreign manufacturers must appoint an authorized Indian agent to act as their representative in India. The authorized Indian agent will serve as the point of contact for inspection authorities, assist in device approvals and registration processes, and handle vigilance/adverse event reporting. It is crucial to choose an authorized Indian agent who possesses a wholesale drug license (20B and 21B) and is licensed to either sell wholesale or manufacture drugs in India. The authorized Indian agent will liaise with the CDSCO's Medical Devices Division and ensure compliance with the registration process.

Step 3: Prepare and Submit the Regulatory Dossier

The next step in the COPP process is to prepare and submit the regulatory dossier to the CDSCO. The regulatory dossier includes essential documents and forms required for registration. Some of the key documents to be included in the dossier are:

1. Form 40: This form serves as the application form for registration and provides essential information about the medical device or pharmaceutical product.
2. TR6 Challan: A proof of payment for the CDSCO fees associated with the registration process.
3. Power of Attorney: A legal document authorizing the authorized Indian agent to act on behalf of the foreign manufacturer.
4. Schedule D(I): A list of all the notified medical devices and their respective classifications.
5. ISO 13485 Certificate: A certification demonstrating compliance with the international standard for medical device quality management systems.
6. Full Quality Assurance Certificate: A certificate indicating that the medical device or pharmaceutical product meets the required quality standards.
7. CE Design Certificate: A certificate issued by a European notified body confirming compliance with European Union regulations.
8. Declaration of Conformity: A document confirming that the medical device or pharmaceutical product complies with relevant regulations and standards.
9. Free Sale Certificate: A certificate issued by the regulatory authority of the exporting country, indicating that the product is freely sold in that country.
10. Certificate of Marketability from GHTF Countries: Additional certification from countries participating in the Global Harmonization Task Force (GHTF), indicating marketability of the product.
11. Other Regulatory Approvals: Any additional regulatory approvals obtained from relevant authorities.
12. Post-Market Surveillance (PMS) Report: A report detailing the surveillance activities conducted on the medical device or pharmaceutical product after it has been placed on the market.
13. Plant Master File: A comprehensive document providing detailed information about the manufacturing facility, processes, and quality control measures.
14. Device Master File: A compilation of technical information and specifications for the medical device.

Ensure that all documents are accurately completed, signed, and provided in the required format. Submit the regulatory dossier to the CDSCO along with the applicable fees. The CDSCO fees for a single manufacturing site are US $1500, and US $1000 for a single device family.

Step 4: Query Resolution and License Issuance

Upon submission of the regulatory dossier, the CDSCO will review the documents and may issue a query letter within approximately three months. It is important to promptly address the queries raised by the CDSCO to ensure a smooth registration process. Once all queries have been satisfactorily resolved, the CDSCO will issue the registration certificate in Form 41. The registration certificate is valid for a period of three years.

Step 5: Obtain an Import License

In addition to obtaining the registration certificate, foreign manufacturers must also obtain an import license to bring their medical device or pharmaceutical product into India. The import license application form, known as Form 10, should be completed and submitted directly by the distributor to the CDSCO. It is important to note that the import license is the regulatory permission required to import the product and comply with customs requirements. The import license is different from the import registration certificate, which is obtained earlier in the registration process.

Benefits of Obtaining a COPP in India

Acquiring a Certificate of Pharmaceutical Product (COPP) in India offers several benefits for manufacturers:

1. Market Access: The COPP ensures compliance with Indian regulations, allowing manufacturers to import, license, and market their medical devices or pharmaceutical products in India.
2. Regulatory Compliance: The COPP demonstrates adherence to quality standards and regulatory requirements, instilling confidence in healthcare professionals and consumers.
3. Streamlined Approval Process: By obtaining a COPP, manufacturers can streamline the approval process for their products, potentially reducing the time taken for market entry.
4. Competitive Advantage: Having a COPP enables manufacturers to compete effectively in the Indian market, ensuring their products meet the necessary regulatory standards and gain recognition among healthcare providers and patients.
5. Expansion Opportunities: With India's growing demand for high-quality medical devices and pharmaceutical products, obtaining a COPP opens doors for manufacturers to expand their business and tap into this lucrative market.

Documents Required for WHO-COPP Certificate Application from CDSCO

Application for WHO-GMP Certification & Issuance of COPP:

1. Applicant Details:

   • Name
   • Address
   • Telephone
   • Fax
   • Email

2. Manufacturing Details:

   • Copy of Manufacturing Licence
   • List of approved products
   • List of products with valid CoPP (For revalidation of CoPP)
   • List of products applied for issuance of COPP & their composition

3. Site Documentation:

   • Site Master file (as per WHO TRS 823)
   • Manufacturing Plant layout
   • Schematic diagram of water system (with circulation loop and MOC)
   • Schematic diagram of HVAC system (with terminal filter configuration)

4. Product Data:

   • Master manufacturing formula & process
   • Finished product specification & Method of Analysis
   • Stability study evaluation for 3 batches (Details as per Format-A)
   • Process validation report for 3 batches
   • Validation report of analytical method
   • Product summary sheet (as per Format B)
   • Actual labels of the products applied for WHO-CoPP
   • Certificates of Analysis for three batches of each product

5. Staff & Equipment Details:

   • List of technical staff (with qualification, experience, and approval status)
   • List of equipment and instruments

6. Operational Protocols:

   • List of SOPs (Standard Operating Procedures) and STPs (Standard Testing Procedures)

7. Export & Compliance:

   • Export data of the last 2 years (For re-validation of CoPP)
   • Proof of safety and effectiveness (As per Rule 158B of Drugs & Cosmetic Rules, 1945)
   • List of Reference standards/marker for all active ingredients/formulation
   • Undertaking regarding absence of non-herbal ingredients in products
   • Undertaking on compliance with domestic regulations (Drugs & Cosmetics Act, 1940, Drugs & Magic Remedies Act, 1954, etc.)

Connect with Our Experts

Obtaining a Certificate of Pharmaceutical Product (COPP) in India is a crucial step for manufacturers looking to import, license, and market their medical devices or pharmaceutical products in the country. The step-by-step process outlined in this guide provides a comprehensive overview of the requirements, documents, and procedures involved. It is essential to consult with experts and relevant authorities to ensure compliance with the latest regulations and guidelines. By successfully obtaining a COPP, manufacturers can gain market access, enhance their regulatory compliance, and seize opportunities in India's rapidly growing healthcare industry.

For more information and assistance with the COPP registration process in India, feel free to contact our experienced team of pharmaceutical consultants at +91 - 9999139391 or [email protected].