CDSCO issues course of action for regulatory approvals for combination products for HIV (Antiretroviral), Hepatitis B and C
The Central Drugs Standard Control Organization (“CDSCO”) issued a notice informing about the course of action to be followed with a view to fast track the process of regulatory approvals for combination products for HIV (Antiretroviral), Hepatitis B and C (“combination products”).
In the 33rd Meeting of the Apex committee of CDSCO, held on 21st February 2017, the issue of regulatory approval for the combination products was discussed.
The Apex Committee agreed with the following course of action with regard to the issue of regulatory approvals for combination products:
- The manufacturer must apply for BE NOC and New Drug Application simultaneously to ensure early availability of the important combination products for Indian population.
- Many of the combinations for concomitant use may not have been approved internationally, but may have been approved individually. Given the risk-benefit and recommendations by World Health Organization (“WHO”), the requirement of generated data may be waived based on the fact that the product has been approved for concomitant use by WHO.
- Application for BE NOC for export of such products will be made for pilot studies on batches manufactured at pilot scale and followed by pivotal studies on batches manufactured at pivotal scale.
- The manufacturer must ensure adequate clinical and quality oversight on the conduct of these bioequivalence studies.
- The new application will be accepted by the CDSCO with abbreviated data at pre-screening stage with firm commitment or undertaking to submit complete data prior to grant of approval.
- Waiver for clinical trial may be given for the products recommended by WHO for concomitant use.
This circular is applicable to the products that are recommended by WHO guidelines and Expression of Interest for rational combination of products used for HIV and Hepatitis B and C.