The Indian CDSCO has issued several notices in order to keep up pace with requirements for the ongoing pandemic. They have implemented rules to fast track approvals and also bought in a new amendment on 11th February 2020, wherein apart from 37 notified devices, all the other devices which includes – instruments, apparatus, appliances etc., will be regulated under this legislation. These rules are called the Medical Devices (Amendment) Rules, 2020 and came into force on the 1st day of April, 2020. Apart from this major amendment they have also brought in notices for – test kits, drugs, approvals and several import validations. CDSCO’s updates for Test kits and Drugs including Imports and Regulatory Approvals are :
Change in the Regulatory Approval Process
In order to support manufacturer’s the CDSCO has implemented a new rule to fast tract the approval process for diagnostics, therapeutics, vaccines and precautionary medicines used in the treatment of COVID-19.
Also, all the other devices (apart from the 37 notified devices) will have to be regulated. Registration under this chapter will be on a voluntary basis for 18 months from 1st April 2020 to 1st October 2021
Test Kits used in the Detection of COVID-19
The import and marketing of COVID-19 test kits would be processed in high priority within 7-days.
USFDA approved test kits will not have to undergo validation.
CE-IVD approved/ Non US-FDA approved/ Indigenous Kits will have to undergo validation in the first shipment post which they will be tested as per medical rules in 4 months time
Clinical data requirements may be waived off based on company to company basis.
Approvals of several drugs used in the treatment of COVID-19
Taking into account, the acerbity of the situation – the CDSCO has granted approvals for several drugs (Remdesivir Injectable Formulations and Favipiravir Tablets)
However, the above mentioned drugs will be used under several conditions and restrictions in India (i.e) prescription has to be provided
Information on Convalescent Plasma used in COVID-19
Convalescent plasma for patients will be used for patients whose oxygen levels are not stabilizing.
They have issued several prerequisites – ABO compatibility, cross matching of the donor plasma, monitoring of the patient, etc.
Import of Diagnostic Kits
The import of diagnostic kits and reagents can be used only for Research Use Only (RUO)
An undertaking has to be submitted by the applicant wherein he/she declares the use of these kits only by academic institutions.
Conduct of BA-BE Study for Export purposes
In Bioavailability and Bioequivalence study of drugs related to COVID-19, CDSCO has stated that modifications can be undertaken after prior consultation with the Ethics Committee.
It has however been emphasized/clarified that rights, safety and well being of the subjects are being maintained.
Contact us in order to ensure sales are maximum post COVID-19, every manufacturer must look into trying to obtain approvals during these times. Every Manufacturer must know the CDSCO’s updates for Test kits and Drugs including Imports and Regulatory Approvals. To know how Morulaa can help, email us on [email protected] or visit our website to know more.