DRUG REGISTRATION SERVICES
Test License
Effective 19 March 2019 New Drugs are regulated under New Drugs and Clinical trial Rules 2019 which ultimately fall under the ambit of Drugs & Cosmetics Act 1940 & Rules 1945.
download actApplication Form:
Test License for Manufacturer
Where a manufacturer of a pharmaceutical formulation intends to procure active pharmaceutical ingredient, which is not approved under rule 76 or rule 81, for development of formulation and to manufacture batches for test or analysis or clinical trial or bioavailability and bioequivalence study of such formulation, the application for permission to manufacture such drug shall be made to the Central Licencing Authority by the manufacturer of pharmaceutical formulation in Form CT-12 and manufacturer of the active pharmaceutical ingredient in Form CT-13.
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Form Applied |
Approval Received |
Government Fees |
|
Form CT-12 Application For Grant Of Permission To Manufacture Formulation Of Unapproved Active Pharmaceutical Ingredient For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Form CT-15 Permission To Manufacture Unapproved Active Pharmaceutical Ingredient For The Development Of Formulation For Test Or Analysis Or Clinical Trial Or Bioavailability Or Bioequivalence Study |
Rs-5000/- Per Product |
The permission granted under rule 60, as the case may be, shall remain valid for a period of three years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
Test License for Importer
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or bioavailability or bioequivalence study or for examination, test and analysis shall make an application in Form CT-16 to the Central Licencing Authority.
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Form Applied |
Approval Received |
Government Fees |
|
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 |
The licence granted under rule 68 in Form CT-17 shall remain valid for a period of three years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
Why NKG for Drug Regulatory Services
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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regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
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NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
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we help you meet your compliance needs
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.
