CDSCO’s updates for Test Kits and Drugs – Imports and Regulatory Approvals

CDSCO’s COVID-19 Fast-Track Rules
During the COVID-19 pandemic, the Indian regulatory body CDSCO introduced several quick changes to keep up with the urgent need for medical devices, drugs, and test kits. A major amendment came on 11 February 2020, bringing almost all medical devices (not just the earlier 37 notified ones) under regulation. These rules, called the Medical Devices (Amendment) Rules, 2020, became effective on 1 April 2020, with voluntary registration open until October 2021. Alongside this, CDSCO issued updates for test kits, drugs, and import processes to speed up availability during the crisis. To support companies, CDSCO created a fast-track approval system for COVID-19-related products like diagnostics, therapeutics, vaccines, and supportive medicines. Test kits used to detect COVID-19 were given high priority import and marketing applications were processed within 7 days. Kits already approved by the USFDA did not require additional validation, while CE-IVD, non-USFDA, and indigenous kits needed validation for the first shipment. In some cases, CDSCO even waived clinical data requirements depending on the company’s situation. CDSCO also allowed emergency use of certain drugs such as Remdesivir and Favipiravir, but only under strict conditions and with a doctor’s prescription. They issued guidance on using convalescent plasma for patients whose oxygen levels were not improving, along with key safety requirements like blood group compatibility and monitoring. Additional changes covered imports and research. Diagnostic kits imported for research could only be used for Research Use Only (RUO), and the applicant had to declare their restricted use. For BA/BE (Bioavailability–Bioequivalence) studies related to COVID-19 drugs, CDSCO allowed certain modifications but only after consulting an ethics committee to ensure the safety and rights of participants.

CDSCO’s COVID-19 Fast-Track Rules

During the COVID-19 pandemic, the Indian regulatory body CDSCO introduced several quick changes to keep up with the urgent need for medical devices, drugs, and test kits. A major amendment came on 11 February 2020, bringing almost all medical devices (not just the earlier 37 notified ones) under regulation. These rules, called the Medical Devices (Amendment) Rules, 2020, became effective on 1 April 2020, with voluntary registration open until October 2021. Alongside this, CDSCO issued updates for test kits, drugs, and import processes to speed up availability during the crisis.

To support companies, CDSCO created a fast-track approval system for COVID-19-related products like diagnostics, therapeutics, vaccines, and supportive medicines. Test kits used to detect COVID-19 were given high priority import and marketing applications were processed within 7 days. Kits already approved by the USFDA did not require additional validation, while CE-IVD, non-USFDA, and indigenous kits needed validation for the first shipment. In some cases, CDSCO even waived clinical data requirements depending on the company’s situation.

CDSCO also allowed emergency use of certain drugs such as Remdesivir and Favipiravir, but only under strict conditions and with a doctor’s prescription. They issued guidance on using convalescent plasma for patients whose oxygen levels were not improving, along with key safety requirements like blood group compatibility and monitoring.

Additional changes covered imports and research. Diagnostic kits imported for research could only be used for Research Use Only (RUO), and the applicant had to declare their restricted use. For BA/BE (Bioavailability–Bioequivalence) studies related to COVID-19 drugs, CDSCO allowed certain modifications but only after consulting an ethics committee to ensure the safety and rights of participants.

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.