What is the complete and exact list of documents required to import a pharmaceutical product from foreign countries into India?

What is the complete and exact list of documents required to import a pharmaceutical product from foreign countries into India?

In India, import, manufacturing, sale, and distribution of the drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. Further license varies upon the type of Drug. Mainly Drug and New Drugs As classified under the act. If drug to be imported, comes under the category of drug as per Section 3B of the act you need to register the drug for Import. If the drugs, fall within the definition of New Drug (Rule 122 E of the Act), the new drug approval is required prior to application for Registration and or import of drug. Not only drug but you also need to register the manufacturing site for import. such an application is made to Drugs Controller General (I) at CDSCO, New Delhi by an Authorised Agent of Manufacturer or person having a wholesale license. Form 40 is required to be filled along with prescribed fees for Premises(1500 USD) and each drug (1000 USD) per drug. Other fees are also to be paid for the purpose of Inspection. 1. Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B. 2. Free Sale Certificate (FSC) stating that the proposed drug is freely sold in Country of Origin and can be legally exported. 3. Certificate of Pharmaceutical Products (COPP) as per WHO scheme for each drug issued by the National Drug Regulatory Authority of the country of origin in prescribed format 4. A valid copy of Manufacturing License or Market Authorization certificate issued by the National Drug Regulatory Authority of the Country of origin If available, free sale certificate also be submitted 5. Product Registration Certificate: The valid copy of Product Registration Certificate wherever applicable in respect of the foreign manufacturing site 6. Soft copy of the Plant Master File and Drugs Master File shall be submitted along with the application. 7. Valid copy means Duly notarized/Attested (by Indian Embassy the country of origin). 8. And Last but not least is Custom Clearance and IEC


Visit HireCA.com Now