Biosimilars in India – Things you need to know · Cliniexperts

Biologicals
Clinical Trials
Consumer Claims - Cosmetic
Consumer Claims - Food
Consumer Claims
Diagnostic Kits
Drug
Medical Devices
Biostatistics
Clinical Study Report
CTRI
Data Management
Ethics Committee
Medical Writing (Protocol)
Project Management
Vendor Management
Site Management
Claim Support Studies - Cosmetic
Claim Support Studies - Food
Clinical Investigation of a Device
Clinical performance evaluation for IVD MD
Phase 1 Trial
Phase 2 Trial
Phase 3 Trial
Phase 4 Trial (PMS)
Pilot clinical investigation
Pivotal clinical investigation
Biologicals - Stem cells and cell-based products
Biologicals Blood Products
Biologicals rDNA Products
Biologicals Vaccines
Drug - SND
Drug-FDC
Drug-IND
Drug-New Drug
Drug-Phytopharmaceuticals
IVD - Class B
IVD - Class C
IVD - Class D
IVD-Class A
Medical Device - Class A
Medical Device - Class B
Medical Device - Class C
Medical Device - Class D

Frequently Asked Questions

In which cases the extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible?

The extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible if following conditions are met: Similarity with respect to quality has been proven to reference biologic Similarity with respect to preclinical assessment has been proven to reference biologic Clinical safety and efficacy is proven in one indication Mechanism of action is same for other clinical indications Involved receptor(s) are same for other clinical indications New indication not mentioned by innovator will be covered by a separate application.

The permission to initiate clinical trial granted in Form CT-06 or automatic approval in Form CT 4A shall remain valid for a period of 2 years from the date of its issue, unless extended by the CLA.

Form MD 24 is an application form to get the grant or permission to conduct a performance evaluation of a new in-vitro diagnostic kit.

Yes. Clinical trial at each site shall be initiated after the approval of the clinical trial protocol and other related documents by the Ethics Committee for that site, registered with the CLA.

Yes. Before enrolment of first participant in any clinical trial, registration in CTRI is mandatory.

The three tier mechanism comprises the following authorities: 1. Institutional Biosafety Committee (IBSC) at the Institute/ company – To ensure biosafety on-site . 2. Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology - Managed genetically engineered cell banks. 3. Genetic Engineering Appraisal Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)- for genetically modified organisms/ living modified organisms.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial of a biological product can submit application for clinical trial.

The study must be initiated within one calendar year of receiving the permission. If permission is not granted, it will need to be approved in advance. The sponsor should submit an annual status report on the study to Central Licensing Authority. If the investigation ends, it should also be reported within thirty days.

After obtaining permission in CT-11 or CT-14 or CT-15 as the case may be, the person, who intends to manufacture the biological product for CT, shall make an application for grant of license to manufacture the biological product by the respective State Licensing Authority (SLA) in accordance with the provisions of the Act and the Drugs and Cosmetics Rules, 1945.

No. For biological product and substances discovered or developed in countries other than India, Phase I data should be submitted along with the application. After submission of Phase I data generated outside India to the Central Licensing Authority, permission may be granted to repeat Phase I trials or to conduct Phase II trials and subsequently Phase III trial concurrently with other global trials for that biological product.

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