Schedule-12
(Relating to Sub-rule (1) of Rule 8)
Application for license to conduct clinical trial
The Administrator,
Department of Drugs Administration.
Sir,
Whereas, I/we intend to conduct the clinical trial of the following drug;
Now, therefore, I/we have made this application, setting out the following matters
and affixing a stamp of one rupee hereto, to obtain the license for the same.
1. Of the new drug of which clinical trial is to be conducted:

2. Of the disease to be suffered by a patient or person on whom clinical trial is
conducted:
(a) Name:
(b) Method of diagnosis:
3. Of the consumption of the new drug to be administered in the course of clinical
trial:
(a) Method:
(b) Mode:
(c) Dosage (daily):
(d) Period:
4. Mode of clinical trial:–
5. Place where clinical trial is or intended to be conducted:
(a) Name and address of hospital:
(b) Name and address of other doctor:
6. Of the person on whom clinical trial is intended to be conducted:
(a) Name and surname:
(b) Address:
(c) Occupation:
(d) Qualifications:
7. Mention whether the following details of the new drug are attached or not:
(a) Toxicological report:
(b) Quality control method:
(c) Other necessary matters:
Applicant’s:
Signature:
Name and surname:
Address: