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Drug Regulatory
  • Investigational New Drug (IND) means a new chemical entity or a product having therapeutic indication but which have never been earlier tested on human beings.
     
  • 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. The Rules 122A, 122B and 122D, 122 DA, 122E of Drugs and Cosmetics Rules and Appendix I, IA and VI of Schedule Y, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country.

       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 of clinical trials  and  new drugs may vary depending on nature of new drugs Like New Drugs viz. Investigational New Drugs, New drugs substances, additional strength, additional indication, modified  release form etc.

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