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Clinical Trials

Clinical Trials

Overview of Clinical Trials in India

Clinical Trial is defined by the New Drugs and Clinical Trials Rules, 2019 as a means of systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the new drug. Whereas a global clinical trial refers to any clinical trial conducted as a part of multinational clinical development of a drug..

Before a drug product can be approved for import, manufacturing, or marketing in India, its safety and efficacy for human use must be established through such trials.

 

Regulatory Requirements for Clinical Trials

A Clinical Trial on a new drug shall be initiated only after the:

  •  Permission from the Licensing Authority under rule 21 (b),
  • Approval obtained from the respective Ethics Committee(s).

The Chapter V Part A and Second and Third Schedules of New Drugs and Clinical Trials Rules, 2019 describe the information/data required for approval of clinical trial in the country. These sections outline the data and documentation required for obtaining approval to conduct clinical trials. However, the specific requirements may vary depending on nature of new drugs which is defined as per the Rule 2(w) of New Drugs and Clinical Trials Rules, 2019.

 

Clinical Trial Phases Based on Drug Origin

· For new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I.

· For new substances discovered in countries other than India, Phase I data as required along with the application. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to:

  • repeat Phase I trials in India
  • conduct Phase II Phase III trials concurrently with other global trials for that drug.

· Phase III trials are required to be conducted in India before permission to market the drug in India is granted.

The extent of data required will depend upon the purpose of the new drug application.

 

Mandatory Trial Registration

Registration of all clinical trials in the Clinical Trials Registry India (CTRI) is mandatory as per notification of the Drugs Controller General India (DCGI). The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics, is a free and publicly accessible online record system for registration of clinical trials being conducted in India.

 

Application Process and Documentation

Permission to conduct clinical Trial in India is granted by Central Drugs Standard Control Organization(CDSCO)/Drugs Controller General of India (DCGI) in Form CT-06 under the Rule 22 of the NDCT Rules, 2019.

Applicant is required to submit application in Form CT-04 along with prescribed fees via Bharatkosh challan and all relevant data as per New Drugs and Clinical Trials Rules, 2019, for seeking permission to conduct of clinical trials in India. The Comprehensive documentation include:

· Chemical and pharmaceutical information,

· Animal pharmacological and toxicological data,

· Clinical safety and efficacy data,

· Regulatory status in other countries

· Results of clinical trials on the Indian population.

These trials and requirements ensure that all new drug intended for import, manufacture, or marketing in India meet the highest standards of safety and efficacy.

To Know More : https://cliniexperts-research.com/clinical-trial-india/drug/