The New Drugs & Clinical Trial Rules, 2019 establishes the procedure for Clinical Trial of Biologicals including a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, stem cell derived product, gene therapeutic product intended to be used as drug and are considered as biologicals. CliniExperts can assist
Classification of Biologicals
Clinical trial review process for Biologicals/similar biologicals products in India
Biologicals must be validated by detailed clinical trials that prove their safety and efficacy in treating the indicated disease.
CDSCO regulates the manufacture and import of biologicals in India.
The organization is responsible for:
Approving clinical trials
Granting permission to import biologicals for local trials
Authorizing firms to export biologicals for biochemical and immunological analysis
For conducting human clinical trials, approval from the Review Committee on Genetic Manipulation (RCGM) is required.
After getting approval from the above competent authority, the application is made to CDSCO for clinical trial and/or marketing of biological/biosimilar products in India.
Clinical Trial Steps
The clinical procedures for regulating biologics and biosimilars can be exhausting.
With over a decade of experience in the clinical space, CliniExperts has all you need to ease things by taking care of all the regulatory matters and trial procedures for you.
A clinical trial application for biologics or similar biologics is submitted using Form CT-04 along with fees for various phases of clinical trial. The CDSCO then has 90 calendar days to evaluate a biological application if it is being developed outside India and 30 days if it is discovered, researched, and manufactured in India. If the CDSCO does not respond, in this time frame, permission is automatically granted. CDSCO, with the approval from the Central Government, can also waive the requirement for a local trial if the biological has already been approved outside India in certain countries as per periodic order released.
The CDSCO’s review and approval process is a three-tiered system.
Evaluation of clinical trial applications and new drugs
Review of SEC’s/IND’s recommendations
Final review and approval Final review and approval