Licence in Form CT 17 for Import of New Drugs and Investigational new Drugs for clinical Trial or Bioavailability or Bioequivalence study or for examination, test and Analysis.
Introduction: Importing new drugs or investigational new drugs for clinical trials, bioavailability, or bioequivalence studies requires a license in Form CT 17 issued by the Central Licensing Authority. This article provides an overview of the licensing process, including application procedures, verification, conditions, validity, and appeal mechanisms.
When any person wants to import any New Drugs or any Investigational New Drugs as defined below for the purpose of Clinical Trial or Bioavailability or Bioequivalence Study (as defined below) or for Examination, Test and Analysis he may import subject to the condition that he should have Import licence in the prescribed form CT 17 issued by the Central Licensing Authority.
The person intending to import any such Drugs is required to electronically apply in the prescribed form CT16 to the Central licensing Authority. At present the Government Fees for application for the licence is Rs. 5000 per product. The applicant is required to submit the requisite information and documents by uploading on the web site of the Central Licensing authority.
The Central licensing Authority will verify all the information and documents submitted along with the application and if required will make further inquiry and if satisfied that the all the requirement of the New Drugs and Clinical Trials Rules, 2019 the Central licencing Authority will issue Licence in the prescribed Form CT17 to import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis in Form CT-17 within a period of ninety days from the date of receipt of its application in FormCT-16.The Central Licensing authority will intimate the applicant about the deficiency, if any, noticed in the application within the stipulated time period.
The Central Licencing Authority is if not satisfied that the New Drugs and Clinical Trials Rules, 2019 have been complied with the Central Licencing Authority will reject the application with reason for rejection in writing with in the period of ninety days from the date of the application made. If the application is so rejected by the Central Licencing authority the applicant may resubmit the application or provide further information or and documents as may be required by the Central Licencing Authority within the stipulated time period to rectify the deficiencies as may be raised by the Central Licensing Authority.
The Central Licensing Authority will again verify the information and or documents as may be required and if satisfied, will issue Licence else will reject the application within Ninety working days from the day on which the further information or and documents are provided by the applicant for removing the deficiencies. In case of rejection of the application, the applicant may after submission of required information and documents as required by the Central Licencing Authority, request the Central Licencing Authority, to reconsider the application within a period of sixty days from the date of rejection of the application on payment of the specified fee.
An applicant who has made application to the Central Licencing Authority for issue of the licence and the applicant is aggrieved by the decision of the Central Licencing Authority, the applicant may application file before the Central Government within the Sixty days from the date of the receipt of such rejection and the Central Government may, after such enquiry as may be thought fit, and after giving the requisite opportunity of being heard to the appellant, dispose of the appeal within a period of the sixty working days.
Validity period of Licence
The Licence so issued in the Prescribed form CT 17 will be remained valid for a period of Three years from the date of issue unless otherwise cancelled or suspended by the Central Licencing Authority. The Central Licencing Authority may, in exceptional circumstances and if the Licencing authority is satisfied about the necessity and exigency, on the request made in writing by the applicant, extend the validity of the Licence so issued further period of one year.
Condition of the Licence
The licence issued in the Form CT 17 is subject to the following conditions:
- It is the licensee’s responsibility that the new drugs has been manufactured in accordance with the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the New Drugs and Clinical Trials Rules, 2019 and Principles of Good Manufacturing Practices.
- The licensee shall make use of a new Drugs or substance relating thereto imported on the basis of the licence issued in the Form CT 17 only for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis and no part of such new drug of substance relating thereto shall be sold in the market or supplied to any other person or agency or institution or organization.
- the licensee shall maintain records of imported new drug or substance relating thereto to indicate the quantity of drug imported, used, disposed of in any manner and other matters related thereto;
- where the imported new drug or substance relating thereto is left over or remains unused or gets damaged or its specified shelf life has expired or has been found to be of sub-standard quality, the same shall be destroyed and details of action taken in such cases shall be recorded.
Inspection of the imported new drugs for clinical trial or the bioavailability or bioequivalence study or for examination, test and analysis.
The person who imports a new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis under CT 17 shall allow any officer authorized by the Central Licensing Authority to enter in the premises where a new drug or substances relating thereto imported has been manufactured, imported and stocked or stored or is being used for the purpose of inspection or investigation of the such premises, with or without notice, in the manner in which such drug is being stocked or used or take sample thereof if so required by the Central Licencing Authority or his authorized person.
Cancellation or Suspension of import licence of new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis.
The Central Licencing Authority is of the opinion that the person to whom the licence has been issued or granted fails to comply with the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and Rules and the New Drugs and Clinical Trials Rules, 2019 may, at any time after giving opportunity of being heard and to show cause, by order in writing cancel or suspend the licence so issued or granted to such person for import of the new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis for such period as may be considered appropriate either wholly or in respect of the specified substance to which the violation of the applicable provisions of the Act the Drugs and Cosmetics Act, 1940 (23 of 1940);or rule relates and also direct that the imported new drugs to be disposed off in the manner as may be specified in the order.
Appeal to the Central Government
Where the person whose licence has been cancelled or suspended by the Central Licencing Authority by order in writing such person may within forty five day from the date of the receipt of the order of cancellation or suspension and aggrieved by such order may prefer appeal before the Central Government. The Central Government may, after such enquiry as may be considered necessary, pass within Sixty working days from the date of filing of the appeal.
Requirement of Labelling and Manner of labelling.
Where any new drug or substance or investigational new drugs is imported for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis ,such drugs should be packed in container and the container should be bearing labels. The label should be showing the following:
1. Name of the drug or code number of the drug.
2. Name and address of the manufacturer of the drug.
3. Name of the actual manufacturing site of the drug.
4. Batch number or lot number of the drug (wherever applicable).
5. Date of manufacturing of the drug.
6. Use before date (date of expiry of the drug).
7. Storage condition of the drug (Required Temperature for storage of the drug)
8. Name of the institution or organisation or the centre where the clinical trial or bioavailability or bioequivalence study or for examination, test and analysis is proposed to be conducted.
9. Purpose for which the drug has been imported.
A licensee may imports new drug or an investigational new drug is imported by the licensee on behalf of another person, in such case the label should show the following detail also:
1. The name and address of the importer
2. The person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified
- The purpose for which it is manufactured.
Alteration, obliteration or defacement of any inscription or mark made on the container, label or wrapper of any new drug imported shall not be made by any person or importer without permission of the Central Licensing Authority.
Definition
As per Rule 2 of the New Drugs and Clinical Trials Rules, 2019.
(f) “bioequivalence study” means a study to establish the absence of a statistically significant difference in the rate and extent of absorption of an active ingredient from a pharmaceutical formulation in comparison to the reference formulation having the same active ingredient when administered in the same molar dose under similar conditions;
(g) “bioavailability and bioequivalence study centre” means a centre created or established to undertake bioavailability study or bioequivalence study of a drug for either clinical part or for both clinical and analytical part of such study;
(j) “clinical trial”
in relation to a new drug or investigational new drug means any systematic study of such new drug or investigational new drug in human subjects to generate data for discovering or verifying its,-
(i) clinical or;
(ii) pharmacological including pharmacodynamics, pharmacokinetics or;
(iii) adverse effects, with the objective of determining the safety, efficacy or tolerance of such new drug or investigational new drug;
(r) “investigational new drug” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country;
(w) “new drug” means,
(i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act the Drugs and Cosmetics Act, 1940 (23 of 1940); and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or
(ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or
(iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or
(iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or
(v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug;
Explanation.- The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new.
Conclusion: Obtaining a license in Form CT 17 for importing new drugs or investigational new drugs is essential for conducting clinical trials and related studies in India. Compliance with the licensing process, including thorough documentation, adherence to reporting requirements, and maintaining quality standards, is crucial to ensure regulatory approval and avoid penalties. By following the prescribed procedures and meeting regulatory standards, stakeholders can contribute to the advancement of medical research while ensuring patient safety and regulatory compliance.
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