GUIDANCE ON TEST LICENSE OF DRUGS AND MEDICAL DEVICES

Medical devices are the devices that are used in the diagnosis, treatment, prevention, or mitigation of disease or any disorder in human beings or animals. These medical devices are regulated by the Drugs and Cosmetics Act 1940, Medical Devices Rule, 2017, and Drug & Cosmetic Rules, 1945. Not all medical devices and drugs are regulated by the above-mentioned Act. Only the government notified medical devices are regulated.

WHAT IS A TEST LICENSE (FORM 11)

A test License is an approval to import small quantities of drugs or medical devices, the ones that are banned under section 10 of the Drugs and Cosmetics Act and Rules,1945 for tests, or analysis. It is essential to import New drugs for testing or clinical trials. Furthermore, narcotic drugs obtain the license through the company, that applies for the test license and reaches CBN Gwalior to collect NOC for the same.

PROCEDURE TO OBTAIN FORM 11

Prior to obtaining form 11, form 12 has to be filled, which is available on the CDSCO’s SUGAM portal. While applying, the applicant has to consider certain conditions in accordance with Rule 33 of the Drugs and Cosmetics Acts and Rules:

• The drugs shouldn’t be imported for achieving any other commercial purpose

• The imported substances must be used for the purpose of test analysis

• Drug Inspector is empowered by the licensing authority to scrutinize the premises with or without the notice

• The licensee has to keep a record and report the same to the authority

• The package inserts of such drugs have to be tested

DOCUMENTS REQUIRED FOR FORM 11

• Covering letter

• Form 12

• TR 6 challan utilization

• Testing protocol

• Product labels and brochures

• Free sale certificate in the originating country

• Notarized agreement

• Ethics committee approval

The license shall be valid for one year from the date of issue, however, it doesn’t have a renewal facility. The company needs to apply for a new Form 11 along with the necessary documents and challan.

The Licensee can be rejected on grounds, such as

• Banned drugs

• Starting material

• Herbal/ agricultural products

• Excipients

WHAT IS A PERSONAL LICENSE?

Any individual or hospital, on the issuance of a doctor’s prescription, can import new drugs under CT Form-16. Form 16 is issued under the Drugs and Cosmetics Act,1940, and Rules 1945.

HOW TO GET NOC FOR DRUGS?

If any goods need to be imported or exported, which are medical-related goods, it has to get approval with a NOC from the Drug controller office of government. No objection Certificates can be obtained from Form-25 and Form-28. This is a permit provided to manufacturers of medical products who are authorized by government agencies of their manufacturing country. 

Necessary documents for filing the form for NOC for the export of drugs in India are listed below:

• Covering letter

• Purchase order

• Manufacturing license

• Perform invoice

• Registration Certificate from the NRA of importing country

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Author:

Ruprekha Jena
Bhubaneswar
3rd Year Law Student from KIIT School of Law, Bhubaneswar