Form 44(INDIA)
(See rules 122 A, 122 B, 122 D, and 122 DA)
Application for grant of permission to import or manufacture a New Drug or to
undertake clinical trial.
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I/we ________________________________________________________ of M/s.
_________________________________________________ (address)
hereby apply for grant of permission for import of and/or clinical trial or for approval
to manufacture a new drug or fixed dose combination or subsequent permission for
already approved new drug. The necessary information / data is given below:
1. Particulars of New Drug:
(1) (1) Name of the drug:
(2) (2) Dosage Form:
(3) (3) Composition of the formulation:
(4) (4) Test specification:
(i) (i) active ingredients:
(ii) (ii) inactive ingredients:
(5) (5) Pharmacological classification of the drug:
(6) (6) Indications for which proposed to be used:
(7) (7) Manufacturer of the raw material (bulk drug substances):
(8) (8) Patent status of the drug:
2. Data submitted along with the application (as per Schedule Y with indexing and page
nos.)
A. Permission to market a new drug :-
(1) (1) Chemical and Pharmaceutical information
(2) (2) Animal Pharmacology
(3) (3) Animal Toxicology
(4) (4) Human/Clinical Pharmacology (Phase I)
(5) (5) Exploratory Clinical Trials (Phase II)
(6) (6) Confirmatory Clinical Trials (Phase III) (including published review
articles)
(7) (7) Bio-availability, dissolution and stability study Data
(8) (8) Regulatory status in other countries
(9) (9) Marketing information:
(a) (a) Proposed product monograph
(b) (b) Drafts of labels and cartons
(10) Application for test license
B. Subsequent approval / permission for manufacture of already approved
new drug:
(a) Formulation:
(1) (1) Bio-availability/ bio-equivalence protocol
(2) (2) Name of the investigator/center
(3) (3) Source of raw material (bulk drug substances) and stability study
data.
(b) Raw material (bulk drug substances)
(1) (1) Manufacturing method
(2) (2) Quality control parameters and/or analytical specification,
stability report.
(3) (3) Animal toxicity data
C. Approval / Permission for fixed dose combination:
(1) (1) Therapeutic Justification
(authentic literature in pre-reviewed journals/text books)
(2) (2) Data on pharmacokinetics/pharmacodynamics combination
(3) (3) Any other data generated by the applicant on the safety and
efficacy of the combination.
D. Subsequent Approval or approval for new indication – new dosage form:
(1) (1) Number and date of Approval/permission already granted.
(2) (2) Therapeutic Justification for new claim / modified dosage form.
(3) (3) Data generated on safety, efficacy and quality parameters.
A total fee of rupees __________________________________________ (in
words). ____________________________) has been credited to the Government
under the Head of Account ________________________ (Photocopy of receipt is
enclosed).
Dated _____ Signature __________________
Designation ________________
Note- Delete, whichever is not applicable.
