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CDSCO to allow processing of application for RC and import license simultaneously

Laxmi Yadav, Mumbai
Friday, February 28, 2020, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organization (CDSCO) has issued a notice allowing submission and processing of application for registration certificate (RC) and import license simultaneously with new drug application.

The notice was issued to all the stakeholders on February 26, 2020.

As per the CDSCO notice, RC and import license shall be granted subject to condition of issuance of the new drug permission under New Drugs and Clinical Trials Rules, 2019.

For import of drugs, the overseas manufacturing sites and the drugs are required to be registered with CDSCO as per the requirements of Rule 24 (A) and 24 of Drugs and Cosmetics (D&C) Rules, 1945. Import of drugs is regulated under chapter III of the D&C Act, 1940 and Part IV of the D&C Rules, 1945.

However, for new drug, permission is required to be obtained under the New Drugs and Clinical Trial Rules, 2019 before obtaining the RC and import license.

Drug industry has been raising concern time and again seeking a system of simultaneous submission and processing of such applications to avoid undue delay.

To address the issue, the national regulatory authority issued the notice stating that the applicant can submit its application for obtaining RC and import license simultaneously, while submitting the application for permission for import of any new drug in the country.

These applications shall be processed simultaneously and RC and import license shall be granted subject to condition of issuance of the new drug permission under New Drugs and Clinical Trials Rules, 2019.

Welcoming the CDSCO circular, SM Mudda, chairman, Regulatory Affairs Committee, Indian Drug Manufacturers' Association (IDMA) said, “It allows concurrent activities of import license as well as registration of clinical trial of new drug which is similar to many other activities taken by CDSCO in recent times. Its simplification of the approval process by maintaining quality, standard as well as compliance.”

Said Amit Chawla, general secretary, Madhya Pradesh Small Scale Drug Manufacturers' Association, “Earlier exporters were required to get import license for new drug and apply for certificate of a pharmaceutical product (CoPP) after conducting clinical trial on it. Now import license and product registration would be issued simultaneously. It will save a lot of time of the industry.”

 

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