Key Insights from the Genome Analysis of the Novel Coronavirus · Cliniexperts

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

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.

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.

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.

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986.

Any biological product manufactured under Form CT-14 & Form CT-15 shall be kept in containers bearing labels, indicating the name of the biological product or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organization or the center where the CT is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been manufactured.

The permission granted in Form CT-11/CT-14/CT-15 to manufacture a biological product or substance to conduct CT shall remain valid for a period of 3 years from the date of its issue, unless suspended or cancelled by CLA. In exceptional circumstances the CLA may extend the period of the permission granted for a further period of 1year.

Related Articles

Biologicals |
Biosimilars in India – Things you need to know · Cliniexperts

Biosimilars in India – Things you need to know Biological agents show significant clinical benefits, but their high cost limits their accessibility. The demand for cost-effective options and the patent expiry of biologics have propelled the development of biosimilars or similar biologics. This article covers the key takeaways from the Indian regulatory guidelines for the

Biologicals |
Human Vaccines – Vaccines Developmental Paradigm India · Cliniexperts

Vaccines are one of the most beneficial and valuable disease prevention measures contributing to long-term health gains. Advancements in research have led to the development of novel vaccines and delivery technologies and this is has caused a paradigm shift in the way diseases are prevented and treated. Even though the field of vaccines have evolved


*All the above fields are mandatory
contact us 2
Enquire now