DRUG REGISTRATION SERVICES
Investigational New Drug (IND)
As per the New Drugs & Clinical Trial Rules 2019, An “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.
CDSCO through the office of Drugs Controller General India, is the Central Licensing Authority for grant of approval of manufacture or import of new drugs in India as well as permissions to conduct clinical trials in India in case of New & Investigational New Drugs.
Application Form :
An Overview of Application Forms, Licenses & Applicable Fees in case of an Investigational New drugs India are clearly prescribed in the New Drugs and Clinical Trial Rules 2019.
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APPLICATION FORM |
APPROVAL FORM |
GOVERNMENT FEES |
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Form CT-04 Application for grant of permission to conduct clinical trial of new drug or investigational new drug |
Form CT-06 Permission to conduct clinical trial of new drug or investigational new drug |
Rs-50,000/- |
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Form CT-4A Information to initiate clinical trial of new drug or investigational new drug as part of discovery, research and manufacture in india |
Automatic approval under rule 23 in Form CT 4A shall remain valid for a period of two years from the date of its issue, unless extended by the Central Licencing Authority |
Rs.50,000/- |
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Form CT-05 Application for grant of permission to conduct bioavailability or bioequivalence study |
Form CT-07 Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug |
Rs.50,000/- |
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Form CT-10 Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis |
Form CT-11 Permission to manufacture new drug or investigational new drug for clinical trial, bioavailability or bioequivalence study or for examination, test and analysis |
Rs.5000/- per product |
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Form CT-16
Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis |
Form CT-17 Licence to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis |
Rs.5000/- per product |
WHY NKG FOR Drug Regulatory Services
Regulatory approvals of a Investigational New Drug under the New Drugs & Clinical Trial Rules 2019is a complicated process. NKG experts work hand in hand with its clients and make the regulatory process smoother and predictable. Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
