June 17, 2020
UPDATE: The CDSCO updated their lists of approved PCR Kits and Rapid Detection Kits for COVID-19.
June 4, 2020
The CDSCO has released Guidlelines for Validation and Batch Testing for COVID-19 Diagnostic Kits along with the Centers approved to provide validation and batch testing of kits. Also included is the format for information for validation of RT-PCR/MA Extraction Kits/VTM and Rapid Antibody Test, Elisa and CLIA
May 19, 2020
- The CDSCO’s approved list of Rapid / CLIA / ELISA Kits for the testing of Covid-19
- The CDSCO’s approved list of PCR Kits for the testing of Covid-19
April 23, 2020
No. 29/Misc/03/2020-DC (60)
RE: Notarized/Apostilled Documents for Applications for Import of MDs and IVDs
The CDSCO has decided that they will allow manufacturers to provide self attestments in lieu of providing authenticated documents as part of the application process with the understanding that the authenticated documents will be provided once the COVID-19 situation normalizes or within 4 months, whichever is earlier.
April 9, 2020
Government of India Exempts Some Products from Customs Duties – Notification No. 20/2020– Customs
Qualifying Products include:
- Artificial respiration or other therapeutic respiration apparatus (Ventilators)
- Face masks and surgical Masks
- Personal protection equipment (PPE)
- Covid-19 testing kits
Manufacturers and Importers of the above items are subject to the condition that the importer follows the procedure set out in the Customs (Import of Goods at Concessional Rate of Duty) Rules, 2017.
March 22, 2020
Commercial International Flights Banned for one week from March 22 – The Indian government on Thursday 19 March 2020, banned commercial international airlines to operate to India for a week from 22 March, following an effort to curb the outspread of COVID-19, which has already seen the country temporarily ban foreigners from entering it.
- “No scheduled international commercial passenger aircraft shall be allowed to land in India from March 22, 2020 for one week,” the government said in an advisory.
March 20, 2020
Regulatory Pathway for IVD Test Kits – X-11026/07/2020 – Regulatory pathways for IVD test kits, expedited approvals and regulatory guidelines.
CDSCO’s Rapid Response Regulatory Framework for COVID-19 – No. BT/03/27/2020-PID
Review Committee on Genetic Manipulation (RCGM) will issue approvals within 7 days if all essential criteria is met.
Initiating research work will be approved within 7 days if essential criteria is met.
Examination of physico chemical and molecular characterization data and approval within 10 days.
Clinical Trial Recommendations from RCGM – 10 days after submission
Approval of FORM 29/Test License/NOC to manufacturer by CDSCO within 10 days of receipt.
CDSCO is creating a CORONA unit to address queries on development and treatments for COVID-19.
Port of Entry Instructions – DGS Order No. 04 of 2020 (March 20) – Instructions for major and minor ports on dealing with Coronavirus Pandemic
Urgent Need for COVID Test Kits, Vaccines and R&D – X-11026-07-2020-PRO
- Any firm having IVD under development for COVID-19 can directly approach DCG(I) through the Public Relations
- Department for guidance on regulatory pathway.
- Any firm that already has an approved IVD in any other country can approach the DCG(I) to discuss an expedited review/accelerated approval.
- Data requirements for clinical performance evaluations may be abbreviated deferred or waived on a case by case basis.
- Applications to manufacture or import COVID IVD test kits for testing and evaluation will be processed on priority within 7 days.
- Applications to manufacture or import COVID IVD test kits for sale and distribution will be processed on priority through expedited review/accelerated approval.