DRUG REGISTRATION SERVICES
BA/BE
Definitions
Bioavailability (BA) :
Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.
Bioequivalence (BE):
Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
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:
Overview of Application Forms, Licenses & Applicable Fees in case of an Imported new drugs as well as new drug manufactured in India are clearly prescribed in the New Drugs and Clinical trial Rules 2019.
BA/BE Study for EXPORT
Any person/sponsor or investigator who intends to conduct BA/BE study for Export of new drug or investigational new drug in human subjects should submit application in Form CT-05 to CLA along with necessary documents specified under Table 2 of fourth schedule and fees as specified under sixth schedule to obtain permission in Form CT-07.
|
Form Applied |
Approval Received |
Government Fees |
|
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/- |
The permission to conduct bioavailability or bioequivalence study granted under rule 34 in Form CT-07 shall remain valid for a period of one year from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.
BA/BE Study for import
Any person or institution or organization who intends to import a new drug or any such substance for BA/BE study for Export shall make an application in Form CT-16 to the CLA. The application shall be accompanied by a fees specified in the Sixth Schedule and such other information and documents as specified in Form CT-16.
|
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
Our team works efficiently to ensure timely communication of documents and submission so that clients can obtain permissions smoothly.
NKG experts are well versed with dossiers for registration under the New Drugs & Clinical Trial Rules 2019 . Our team makes the process of filing and approval under these rules efficient and predictable.
Trust NKG experts to help you with regulatory permissions under the above rules.
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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.
