Conducting clinical trial during COVID-19 · Cliniexperts



Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

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.

An audio-video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.

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.

Related Articles

Clinical Trials |
Drug |
Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments

Unveiled Clinical Trials For Drugs: Exploring Research for New Treatments Summary Clinical trials for drugs are essential to ensure their safety and efficacy. Drug trials usually progress through four phases: I, II, III, and IV. India is an emerging hub for clinical trials due to its diverse population and cost-effectiveness. Regulatory bodies like CDSCO ensure

Clinical Trials |
What are Clinical Trial Phases?

What are Clinical Trial Phases? Introduction Clinical trials are conducted in four or more different phases to evaluate an investigational new drug (IND) and its effect on human health. Through these phases, the drug is discovered, the disease needing treatment is identified, and finally, the drug is submitted for regulatory approvals and launched for sale

Biologicals |
Diagnostic Kits |
Drug |
Medical Devices |
The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug


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