Indian drug regulatory system is governed by the provisions laid down under Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder. With changing times many new rules viz. Medical Device Rules, 2017, New Drugs and Clinical Trial Rules, 2019 and Cosmetics Rules, 2020 have been introduced. As per the legal requirements any firm who wish to manufacture or import any drug in India shall have a licensed issued by the appropriate Licensing Authority. Any firm, who intend to manufacture or import a drug in India for the sole purpose of examination, test and analysis shall have test license.

Various question comes to our mind when we thought of applying for a test license viz. What is test license?, Where to apply?, When to apply?, How to apply?, Why to apply? And many more. In present article we intend to reply to each of these questions for better clarification.

 

 

What is Test License?

 

Any manufacturer who intends to introduce a drug product for the first time in their facility and is not having valid manufacturing license in Form 25 or Form 28 to manufacture such product, he shall obtain a test license i.e., Form 29 from its respective State Licensing Authority.

In case of an importer who wish to import a drug product from any other country not intended for sale shall obtain a test license i.e., Form 11 from Central Licensing Authority (Drugs Controller General of India or an Authorized Authority).

This is to reemphasize that test license is required only for those manufacturers who do not have license in Form 25 or Form 28 to manufacture that particular drug product. Similarly, in case of import, the importer shall not be holding import license on Form 10 for that particular drug product.

 

 

Can the quantities manufactured or imported on test licenses can be sold?

 

No, the quantities manufactured or imported on test licenses cannot be sold or marketed. The test license only permits to manufacture or import a drug solely for the purpose of examination, test or analysis.

 

 

What activities are covered under the phrase “examination, test or analysis”?

 

Practically everything except the sale of drugs for human or veterinary consumption. After obtaining the test license, the firm can initiate the product development, manufacture pilot/ exhibit batches, perform process validations, analytical method validations, drug-excipient compatibility studies, degradation studies, stability studies, clinical studies, BE studies etc.

 

 

Can the data generated from the batches manufactured on test license be used for regulatory filing?

 

Absolutely! In fact test license is the only way to manufacture drug substance or drug products for generation of data. The regulator will grant the commercial license i.e. Form 25 and/or Form 28 only after the assessment of CMC data submitted by the firm.

 

 

When to apply for the test license?

 

Before introduction of any new product in the facility for which the firm is not holding any license in Form 25 or Form 28.

 

 

Which are the licensing authorities for test licenses?

 

  1. For manufacture: State licensing Authorities of the respective state where the manufacturing plant is located are responsible for grant of Form 29 i.e. License to manufacture drugs for examination, test and analysis. However, please be noted that in case of New Drugs as defined under New Drugs and Clinical Trial Rules, 2019, the manufacture shall obtain permission from CDSCO Zonal Offices as applicable and then shall proceed for Form 29 from State Licensing Authorities.
  2. For Importer: Central Licensing Authority (Drugs Controller General of India or an Authorized Authority)

 

 

What are the various types of License/ permission forms applicable?

 

Form 29: License to manufacture drugs for the purpose of examination, test or analysis. This license is granted by State Licensing Authority (SLA). The application for the same is made on Form 30. This License can be directly obtained from SLA in case the drug being applied does not fall in the category of new drug or investigational new drug.

Form 11: License to import drugs for the purpose of examination, test or analysis. This license is granted by Central Licensing Authority (CLA) i.e. Drugs Controller General of India or an Authorized Authority. The application for the same is made on Form 12. This License can be directly obtained from CLA in case the drug being applied does not fall in the category of new drug or investigational new drug.

Form CT11: Permission to manufacture new drug or investigational new drug (ND or IND) for bioavailability or bioequivalence, clinical trial or for examination, test and analysis. This is basically a permission or an NOC to manufacture a ND or IND whose API source is already approved in India and is licensed to manufacture and sale the particular API. In such a case the applicant shall make an application on CT 10 and then he will be granted CT 11. Post receipt of CT11, an application shall be made to SLA, for grant of Form 29.

Form CT15: Permission to manufacture unapproved API for the development of formulation for test or analysis or clinical trial or Bioavailability or Bioequivalence study. This is basically a permission or an NOC to manufacture an unapproved API which shall be used to manufacture a ND or IND. In such a case the applicant shall make an application on CT 13 and then he will be granted CT 15. Post receipt of CT15, an application shall be made to SLA, for grant of Form 29.

Form CT14: Permission to manufacture formulation of unapproved API for test or analysis or clinical trial or Bioavailability or Bioequivalence study. This is basically a permission or an NOC to manufacture a ND or IND whose API source is not yet approved in India. In such a case the applicant shall make an application on CT 12 and then he will be granted CT 14. An important pre-requisite in this case is CT-15 issued to API manufacturer as mentioned above. CT15 has to be submitted along with CT 12 application. Post receipt of CT14, an application shall be made to SLA, for grant of Form 29.

Form CT17: License to import new drug or investigational new drug (ND or IND) for the purpose of bioavailability or bioequivalence, clinical trial or for examination, test and analysis. In such a case the applicant shall make an application on CT 16 and then he will be granted CT 17.

 

Note: One has to understand the difference between the roles of CLA and SLA in grant of License and Permission. Permission is basically an NOC issued by the CLA for the ND or IND or unapproved API to be manufactured in India. In such cases, the applicant has to take license on Form 29 from the respective SLA. However, in cases of import CLA itself is the Licensing Authority, hence, no other licensure from SLA is required.

Concept of test license for manufacturing and import of drugs in India

Fig. Concept of Test license for manufacture and import of drugs in India

 

 

What is the Pathway to obtain a test license for the manufacture of drugs on Form 29?

 Process to obtain test license for manufacture of drugs in India

 

 

What is the Pathway to obtain a test license for the import of drugs on Form 11?

Process to obtain test license for imports of drugs in India

 

 

What is the Pathway to obtain a test license for the manufacture of new drugs/ investigational new drugs/ unapproved API for the purpose of bioavailability or bioequivalence, clinical trial or for examination, test and analysis?

Process to obtain test license for manufacture of new drugs in India

 

 

What is the Pathway to obtain a test license for the import of new drugs/ investigational new drugs for the purpose of bioavailability or bioequivalence, clinical trial or for examination, test and analysis?

Process to obtain test license for import of new drugs in India

 

Note: For understanding new drug approval process in India, please click here.

 

Note: The above pathway is a general overview and process flow for obtaining test license for manufacture/ import of drugs in India. Minor variations to this general pathway may happen on case-to-case basis.

 

To further understand the process of obtaining test license for manufacture/ import of drugs and new drug approval in India or any support in filing of the application, please feel free to write to us on vaayath@gmail.com

 

Author:

Ms. Neha,

Senior Executive – Regulatory Affairs,

Vaayath,

Panchkula, India