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  • CDSCO announces waiver...

CDSCO announces waiver of local clinical trials in 5 drug categories that are approved in developed markets

Ruchika SharmaWritten by Ruchika Sharma Published On 2024-08-08T14:21:37+05:30  |  Updated On 8 Aug 2024 2:21 PM IST
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New Delhi: In a significant move to improve the accessibility of new drugs in India, the Central Drugs Standard Control Organization (CDSCO) has announced a waiver of local clinical trials for certain categories of new drugs approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union. This move marks a major step forward in streamlining the approval process for innovative treatments in the country.

The waiver comes for a limited category of drugs such as orphan drugs for rare diseases, Gene and cellular therapy products, New drugs used in pandemic situations, New drugs used for special defense purposes, and New Drugs having significant therapeutic advance over the current standard care

According to a recent order, the waiver is granted under Rule 101 of the New Drugs and Clinical Trials Rules, 2019.
As per Rule 101 of New Drugs and Clinical Trials Rules, 2019 the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from tirne to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules.

The newly specified countries include the United States, the United Kingdom, Japan, Australia, Canada, and the European Union.

“In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely; US, UK, Japan, Australia, Canada and EU are, hereby, specified for following categories of new drugs…,” said the order.

The waiver applies to following categories of new drugs:

• Orphan Drugs for rare diseases
• Gene and cellular therapy products
• New drugs used in pandemic situation
• New drugs used for special defense purpose
• New Drugs having significant therapeutic advance over the current standard care.

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

To view the official order, click on the link mentioned below:
https://medicaldialogues.in/pdf_upload/dcgijpeg-246853.pdf

Read also: Drugs not yet marketed in India, Submit PSUR Data: CDSCO Panel Tells Novo Nordisk on Semaglutide injection

CDSCOCentral Drugs Standard Control Organizationorphan drugscellular therapy
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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