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Registration Certificate is a certificate issued under Rule 27A of Drugs and Cosmetics Rules, 1945 by the Licensing Authority in Form 41 for registration of premises and the drugs manufactured by the manufacturer meant for import into and use in India.

Import License is either a license in Form 10 to import of drugs excluding those specified in Schedule X, or a license in Form 10-A to import of drugs specified in Schedule X.

As per regulations, a Manufacturer means a manufacturer of drugs which is either a company or a unit or a body or a corporate or any other establishments in the country (other than India) and have drug manufacturing facilities duly approved by the National Regulatory Authority of the concerned country. They have their free sale approval of the drugs approved by NRA in that country and any other major countries.

Import of Drugs for commercial use in India require Registration Certificate in Form 41 and Import License in Form 10 as per the Drugs and Cosmetics Act, 1940.

Application for Registration Certificate to the Licensing Authority is made in Form 40. According to the rules, this is done by either a manufacturer having a valid wholesale license for sale or distribution of drugs or by the authorized agent in India having valid wholesale license. It needs to be submitted along with fees specified in sub-rule (3) of rule 24 A of the Drugs and Cosmetics Rules 1945 along with the information and undertakings specified in Schedule D- I and D-II duly signed by or behalf of the manufacturer. The applicant submits an application as per the checklist available at https:cdscoonline.gov.in through SUGAM Online Portal.