Form 44 - Central Drugs Standard Control …

1 form 44 (See rules 122a , 122B, 122D and APPLICATION FOR GRANT OF PERMISSION TO IMPORT OR MANUFACTURE A NEW DRUG OR TO UNDERTAKE CLINICAL TRIAL. I/We* - - - - - - - - - - - - - - of M/s , - - - - - - - - - -( a d dr e s s )hereby apply for grant of permission for import 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 / date is given below: 1. Particulars of New Drug : (1) Name of the dr ug : (2) Do sa ge Fo rm : (3) Co mpositio n of the formulation : Ingredient Pharmacopical Monograph Category Percentage of Claim of Quantity Strength (4) Test specification : (i) Active ingredients : (ii) Inactive ingredients : (5) Pharmacological classification of the drug : (6) Indications for which proposed to be used.)

2 (7) Manufacturer of the raw material (bulk drug substances) Premises Name Premises Type Premises Address (8) Patent status of the drug Patent Name Patent Number Country Description 2. Data submitted along with the application (as per Schedule Y with indexing and page number:) A. Permission to market a new drug :- (1) Chemical and Pharmaceutical information: (2) Animal Pharmacology Study Status 1. Specific Pharmacological Actions 2. General Pharmacological Actions 3. Follow-up and Supplemental Safety Pharmacology Studies 4.

3 Conditions under which Safety Pharmacology Studies are not necessary 5. Timing of Safety Pharmacology Studies in relation to Clinical Development 6. Application of Good Laboratory Practices (GLP) (3) Animal Toxicology Study Status 1 Genotoxicity 2 Carcinogenicity 3 Single-dose Toxicity Studies 4 Repeated-dose Systemic Toxicity Studies 5 Male Fertility Study 6 Female Reproduction and Developmental Toxicity Studies 7 Local Toxicity 8 Allergenicity/Hypersensitivity (4) Human / Clinical Pharmacology (Phase I): (5) Exploratory Clinical Trials (Phase II) (6) Confirmatory Clinical Trials (Phase III) (including published review articles).

4 (7) Bio -availability, dissolution and stability study Data: (8) Regulatory status in other countries (9) Marketing information (a) Proposed product monograph : (b) Drafts of labels and cartons : (10) Application for test license : (11) New Chemical Entity and Global Clinical Trial: a) Assessment of risk versus benefit to the patients b) Innovation vis- -vis existing therapeutic option c) Unmet medical need in the country Regulatory Status Approval/Withdrawal date Country Reason for Withdrawal B.

5 Subsequent approval / permission for manufacture of already approved new drug : (a) Formulation: (1) Bio -availability / bio-equivalence protocol : (2) Name of the investigator/center : (3) Source of raw material (bulk drug substances) and stability study data. : (b) Raw material (bulk drug substances) (1) Manufacturing method : (2) Quality Control parameters and/or analytical specification, stability report. : (3) Animal toxicity data. : C. Approval / Permission for fixed dose combination: (1) Therapeutic Justification.

6 : (authentic literature in peer-reviewed journals/text books) (2) Data on pharmacokinetics / pharmacodynamics combination.: (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) Number and date of Approval / permission already granted. : (2) Therapeutic justification for new claim / modified dosage form : (3) Data generated on safety, efficacy and quality parameters. : A total fee of (in words).

7 Has been credited to the Government under the Head of Account.(Photocopy of receipt is enclosed). Name : Place : Designation Date : Signature : *Delete whichever is not applicable.