On March 19, 2020, the Central Drug Standard Control Organization has published a notice regarding the regulatory pathway for R&D of IVD kit for diagnosis of COVID-19 in order to encourage the research and development of the kit. Any individual who wishes to propose any new development should submit the application to CDSCO which will be processed on priority basis. CDSCO will also provide regulatory guidance on such matter.1
Following are the details under this provision:
- Any firm having in-vitro diagnostic kit under development for COVID-29 can directly submit the application through Public Relations Office for seeking guidance on regulatory pathways.
- Any firm having in-vitro diagnostic kit under development for COVID-29 in any other country can directly submit the application through Public Relations Office regarding expedited approval in Indian market.
- Data requirement for clinical evaluation may be waived on case-to-case basis depending on type and nature of diagnostic kit, existing data on the product and evidence of available clinical evaluation data of such kit.
- All applications required for manufacturing, import and evaluation of the COVID-19 kit may be processed on priority within 7 days.
- Application required for manufacturing, import and evaluation of the COVID-19 required for sale and distribution would be processed on priority through accelerated review.
Note: For any additional information contact Public Relations Office through toll-free number 1800 11 1454 & write to email@example.com.
Novel Corona-virus Disease (COVID-19) has spread over 118 countries with now more than 191.127 cases and 7807 people have lost their lives as on 18.03.2020. World Health Organization (WHO) has declared it as pandemic. However, there is no current evidence from randomized clinical trials to recommend any specific treatment for suspected or confirmed patients with COVID-19. In order to make new advancements in treating disease, CDSCO has come up with proposal on submitting application based upon the regulatory pathways in developing COVID-19 kit. This will help the society to identify and tackle the disease in a better way with a positive outcome.
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