Importance of COPPs in a Pharma Company
October 5, 2021
India is one of the leading countries when it comes to pharmacy and medicine. It is one of the largest suppliers of generic drugs. The domestic market has more than 3000 medicine franchise companies and around 10,000 manufacturing units. India has always been known for its human resource, we have the best scientists, researchers, and engineers who have helped us achieve this and can further take us to new heights. India stands at the 12th position when it comes to the exportation of medical goods.
What are COPPs?
COPP stands for Certificate of Pharmaceutical Product. This certificate is granted by the National Health Authorities or the drug supplier in that country. This certificate shows whether a certain product is to be sold in the country or not. It also ensures that the manufacturer complies with the rules of GMP, they are subject to regular inspection by the drug suppliers of the country. COPP is issued as recommended by WHO. The importing country must have this certificate for registration, licensing, authorization, and renewal purposes. CPPs are essential in regions like Latin America, Middle East, CIS, etc. these are not mandatory in the countries that fulfill ICH CTD and QSE full reviews criteria. A person or a PCD pharma distributor company that exports the particular product must do a full application for export certification. The drug should meet the criteria of the Food Drug and Cosmetic Act.
The products for which COPP may be issued are API (Active Pharmaceutical Ingredients), OTC (Over the Counter), a homeopathic drug, etc.
Process of getting a COPPs in India:
- The application for the certificate has to be presented to the zonal or sub-zonal officer. Once they perform the inspection and are satisfied, the clearance is given. The certificate is then issued on the behalf of DGCI (Drug Controller General India).
- The application needs to be addressed to the ADC or DDC of the respective officer (zonal or sub-zonal). A cover letter and summary of the pharmaceutical product should be attached with the application.
- It has to be made clear in the application if it is for a new certification or reissue. The CDSCP officer reviews the whole application and gives a green signal if found alright.
- Prepare a forwarding letter, along with that the pharma franchise company also needs to submit the accurate list of products with a summary, the manufacturing license, and site file.
- The medicine franchise companies also need to send documents like quality manuals, validation plans, formula records, and layout along with the application itself.
- Lastly, a list of names of people with their respective qualifications, post, and years of experience needs to be provided too.
Process of COPPs being accepted:
CDSCO checks the application according to the WHO guidelines. A report is made to mention the faults or discrepancies in the application. If rejected, the medicine franchise company has to apply again for the certification after the compliance is done within 5 months. If there is no error in applying then the company might get the certification in a single attempt.
Why is COPP important for Medicine franchise companies in India?
- It is required by the importing country when a certain product is intended for licensing, registration authorization, and prolongation of registration.
- The scope of distribution and commercialization in the importing country.
- WHO recommends the certification to help the small drug regulatory bodies or drug regulatory bodies without proper quality guarantee services in importing nations to examine the quality of the products as an essential for registration or importation.
- If used rationally, the COPP promotes convergence and simplification and also enhances the globalization of the pharmaceutical industry and the medicine franchise companies.
The pharmaceutical industry plays a very significant role in the GDP of India. This industry has boomed due to heavy scientific research, R&D, and many other factors. The COPP is more important now than ever. It is recommended by WHO and the importing country needs to have this certification. Countries like India, Indonesia, Malaysia, Singapore, Saudi Arabia, Argentina, Russia, Turkey, etc need COPP mandatorily.
If you want more ideas and insights regarding the COPP (Certification of Pharmaceutical products), from the leading pharma experts, then get in touch with the support members of Albia Biocare. In case you are looking for expert help in the domain of PCD Pharma distributors, you can definitely consider getting in touch with the members of Albia Biocare. Get ready to make your brand stand out among the top PCD pharma franchise companies in India. Contact the team at 9988289049 for the same.