Application for Registration certificate and import licence may be submitted with application for permission for New Drug

The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) vide a notice dated 26th February 2020 has provides for submission and processing of application for Registration Certificate and import License in parallel with application for permission to import New Drug.

New drug means a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent; and has not been approved as safe and efficacious by Central Licensing Authority (CLA); or a drug approved by the CLA for certain claims and proposed to be marketed with modified or new claims.

As per Drugs and Cosmetics Rules 1945, for import drugs, the overseas manufacturing sites and the drugs are required to be registered with (Central Drugs Standard Control Organization) CDSCO. But for new drugs, the permission is to be obtained under new Drugs and Clinical Trials Rules 2019. Such permission to be obtained before obtaining registration certificate and import licence.

 In this regard, CDSCO is receiving representations seeking a system of simultaneous submission of permission and registration to avoid undue delay. So, to give relief to the stakeholders, CDSCO allows the applicant to submit the application for registration and import licence along with the application for permission to import any new drug to India.

These applications shall be processed simultaneously and registration certificate and import licence shall be granted subject to the condition of issuance of new drug permission under the Drugs and Clinical Trials Rules 2019.

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