Biosimilars in India – Things you need to know · Cliniexperts

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

Related Articles

Biologicals |
Drug |
Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Covid-19 vaccines approved for use in India – What you need to know Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin.

Biologicals |
Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon · Cliniexperts

  Phase 2-3 Clinical Trials for Covaxin To Commence On Children Aged 2-18 Years Soon On the 13th of May, 2021, as per one of the country’s top health officials, India’s very first trial of a domestically manufactured Covid-19 vaccine is all set to commence on children in the next 10-12 days. At the forefront

Biologicals |
COVID-19 – Can patent waivers increase vaccine coverage? · Cliniexperts

COVID-19 – Can Patent Waivers Increase Vaccine Coverage? With the new virus variant causing a surge in infections, India has been crippled by the pandemic. Apart from the shortage of medicines, oxygen and healthcare staff, several states in India face a shortage of vaccines – one of the most effective tools to end the pandemic.


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