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.
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
To increase business in a foreign country it is necessary to obtain the COPP certificates by the pharmaceutical company
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:
COPP is generally issued within20 working days from the date of application and issued certificate expires in 2 years from the date of notarization.
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.
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.
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:
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.
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.
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.
Acquiring a Certificate of Pharmaceutical Product (COPP) in India offers several benefits for manufacturers:
Staff & Equipment Details:
Export & Compliance:
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@example.com.
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