India’s CDSCO Permits Simultaneous Submission of Registration and Import Filings

News date: 03 March 2020Source: https://www.raps.org/news-and-articles/news-articles/2020/3/asia-regulatory-roundup-shortage-mitigating-measu

India’s Central Drugs Standard Control Organization (CDSCO) has changed its procedures for seeking registration certificates and import licenses. CDSCO now permits companies to file for the clearances simultaneously.
 
Companies that want to import drugs into India need to register the manufacturing sites that make the products with CDSCO. For new medicines, companies need to obtain permission under the New Drugs and Clinical Trials Rules, 2019, before getting the registration certificate and import license.
 
The need to seek clearances in sequence has caused frustrations among importers, leading them to call for CDSCO to support the simultaneous submission and processing of applications. CDSCO has now agreed to the request.
 
“The applicant can submit its application for obtaining registration certificate and import license simultaneously, while submitting the application for permission for import of any new drug in the country,” CDSCO wrote in a notice to disclose the change.
 
CDSCO will process the applications simultaneously and grant the registration certificate and import license “subject to condition of issuance of the new drug permission” under the 2019 legislation.