Investigational New Drug (IND)

Investigational New Drug (IND)

Investigational New Drug (IND) means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country.

The office of the Drugs Controller General (India) [DCG(I)] grants approval of manufacture/import of new drugs for marketing in the country. This office is also responsible for grant of permission to conduct clinical trials of new drugs including Investigational New Drugs.

During a new drug’s early preclinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial use in humans and if the compound exhibits pharmacological activity that justifies commercial development. Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country. As per the Rules 2, 21, 23, 33 , Chapter VIII , and as per the requirements of Schedule 1 to 8 of New Drugs & Clinical Trials Rules-2019, the information/data required for approval of clinical trial and/or to import or manufacture of new drug/investignational New Drug for marketing in the country needs to be submitted at CDSCO Sugam online portal for further review by authorities at CDSCO for grant of permission for various stages of clinical trials and Bioequivalence studies till the marketing authorization/New Drug Approval is obtained.

The IND application must ideally contain information in three broad areas:

  • Animal Pharmacology and Toxicology Studies
  • Manufacturing Information
  • Clinical Protocols and Investigator Information

However, the requirements for approval may vary depending upon the suggestions receives from the IND committee, SECs (Subject Experts Committee) and Technical Committee at various stages of IND approvals till receipt of marketing authorization/new Drug Approval for first time in India.

Reference

  1. GSR 227(E): New Drugs and Clinical Trials Rules-2019, Ministry of Health & Family Welfare, Department of Health and Family Welfare, Government of India, 19 March 2019.
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