Key Highlights of New Drugs & Clinical Trial Rules, 2019

Key Highlights of New Drugs & Clinical Trial Rules, 2019 1Ministry of Health and Family welfare, India, notifies New Drugs and Clinical Trials Rules, 2019 vide G.S.R. 227 (E) dated 19 Mar 2019. These rules will apply to clinical trial, bio-availability or bio-equivalence study, new drugs and regulation of ethics committee relating to clinical trial and biomedical health research.

Clinical Trial List:

1. Heading: Approval timelines for conducting clinical trial

Provisions as per Clinical Trial Rules 2019:

For drugs discovered outside India: The disposal of clinical trial application by way of approval or rejection or seeking further information within 90 working days from the date of receipt of the application by the authority for drugs developed outside India

For drugs discovered in India:

The application for conducting clinical trial of a new drug or investigational new drug as part of discovery, research and manufacture in India is to be disposed within a period of 30 working days from the date of receipt of the application by the authority.

Provided that, where no communication has been received from the Central Licencing Authority (CLA), the permission to conduct clinical trial shall be deemed to have been granted by the CLA.

Reference: Chapter V, Part A of Rules, Page No. 156 & Chapter V, Part A of Rules, Page No. 156

2.Heading: Manufacture of new drugs or investigational new drugs for clinical trial, bioavailability or bioequivalence study or for examination, test and analysis

Provisions as per Clinical Trial Rules 2019:

Permission is required from CLA to manufacture a new drug or an investigational new drug to conduct clinical trial or bioavailability or bioequivalence study or for examination, test and analysis

Reference:

Chapter VIII of Rules, Page no. 166-167

3.Heading: Waiver for conducting local clinical trials in India

For drugs discovered in India:

Requirement of local clinical trial may be waived for approval of new drug if drug is approved and marketed in countries specified by CLA and if no major unexpected serious adverse events have been reported.

Local clinical trial may also be waived if the application is for import of a new drug for which the CLA had already granted permission to conduct a global clinical trial which is ongoing in India and in the meantime such new drug has been approved for marketing in a country specified by the CLA; and There is no probability or evidence, on the basis of existing knowledge, of difference in Indian population of the enzymes or gene involved in the metabolism of the new drug or any factor affecting pharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and The applicant has given an undertaking in writing to conduct Phase IV clinical trial to establish safety and effectiveness of such new drug as per design approved by the CLA. CLA may relax this condition, where the drug is
indicated in life threatening or serious diseases or diseases of special relevance to Indian health scenario or for a condition which is unmet need in India such as XDR tuberculosis, hepatitis C, H1N1, dengue, malaria, HIV, or for the rare diseases for which drugs are not available or available at a high cost or if it is an orphan drug.

Reference:

Chapter X of Rules, Page 173 & Chapter X of Rules, Page 173

4.Heading: Validity period of permission to initiate a clinical trial

For drugs discovered in India:

The permission to initiate clinical trial granted by CLA shall remain valid for a period of two years from the date of its issue, unless extended by the CLA.

Reference: Chapter V, Part A of Rules, Page No.157

5.Heading: Post-trial access of Investigational new drug or new drug

For drugs discovered in India:

The sponsor shall provide post-trial access of the investigational drug by giving the drug free of cost to the trial subject as per directions of the CLA in special circumstances on the recommendations of the investigator and the ethics committee and written consent of the patient and; The investigator has certified and the trial subject or his legal heir, as the case may be, has declared in writing that the sponsor shall have no liability for post-trial use of investigational new drug or new drug.

Reference:

Chapter V, Part A of Rules, Page No. 157-158

6.Heading: Pre-submission & Post-submission meetings

For drugs discovered in India:

CLA has included the provision of pre-submission and post submission meeting for seeking guidance about the requirements of law and procedure of license or permission of manufacturing process, clinical trial and other requirements.

Reference:

Chapter XIII of Rules, Page No. 180

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Key Highlights of New Drugs & Clinical Trial Rules, 2019

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