Module 2: Regulatory Dossier

Approval of New Drugs in India

This module is basically compilation of overall documentation requirement for filing a new drug regulatory dossier in India.

1. Form 29: For development of any new drug the applicant is required to obtain license in Form-29 from State Licensing Authority based on NOC obtained from CDSCO. Test batches of new drugs for development and generation of data of any new drug should be manufactured only after obtaining the license in Form-29.

2. Form 44: For permission to import or manufacture of new drug substances and its formulations for marketing in the country, applicant is required to file application in Form 44 along with prescribed fees in the form of treasury Challan and all relevant data as per Schedule Y to Drugs and Cosmetics Rules which include chemical & pharmaceutical information, animal pharmacological & toxicological data, clinical data of safety & efficacy regulatory status in other countries etc. and results of clinical trials on local population. Application in Form 44 complete in all respect duly signed and stamped by authorized person of the firm.

3. Treasury Challan of INR 50,000 (new drug introduced first time in India or approved for less than one year) and INR 15,000 (new drug approved in India for more than one year), of duly signed and stamped by Bank of Baroda – should mention the name of the new drug including correct head of the account, payable at, bank clearance, etc.

4. Copy of valid manufacturing license in Form 25/28/26

5. Source of bulk drugs along with current regulatory status of the source with copy of Form 46A/45A. (If obtained). For manufacturing of bulk drug – Copy of manufacturing license in Form-25/ Form-26 for any bulk drug to manufacturer and Form-29 and for import of bulk Copy of drug sale license in Form 20B and 21B is required

6. If the study drug is intended to be imported for the purposes of examination, test or analysis, the application for import of small quantities of drugs for such purpose should also be made in Form 12.

7. New Drug Information required

a) Name of the New Drug
b) Composition of the New Drug
c) Dosage Form
d) Proposed indication for the New Drug
e) Approved Dosage Form
f) Approved composition
g) Approved indication

8. Information on active ingredients – Detail provided in module 03

9. Data on formulation: Detail provided in module 03

10. Animal Pharmacology and Toxicity Data: Detail provided in module 03

11. Clinical Trial Report of Phase I to Phase III : Detail provided in module 04

12. Protocol of Bioequivalence study along with Informed Consent document and undertaking by Investigator in case of Oral Dosage Forms having systematic absorption. In case of Biowaiver, justification should be submitted.

13. Regulatory status in other countries, as appropriate.

a) Names of the countries where the drug is marketed / approved along with package insert circulated in those countries and since when it is marketed in those countries. Specific names of countries where the drug is marketed should also be mentioned in the covering letter.

b) Names of the countries where the drug is withdrawn, if any, with reasons (Information in respect of restrictions imposed, if any, on the use of the drug in other countries, e.g. dosage limits, exclusion of certain age groups, warning about adverse drug reactions etc.)

c) In case import of drug, free sale certificate (FSC) or Certificate of Pharmaceutical Product (COPP), as appropriate.

14. Copy of proposed prescribing information. The prescribing information (package insert) shall comprise the following sections: generic name; composition; dosage form/s, indications; dose and method of administration; use in special populations (such as pregnant women, lactating women, pediatric patients, geriatric patients etc.); contra-indications; warnings; precautions; drug interactions; undesirable effects; overdose; pharmacodynamics and pharmacokinetic properties; incompatibilities; shelf-life; packaging information; storage and handling instructions.

15. Proposed Draft specimen of the label and carton. The drafts of label and carton texts should comply with provisions of Rules 96 and 97.

16. Samples and Testing Protocol/s

Samples of pure drug substance and finished product (an equivalent of 50 clinical doses, or more number of clinical Doses, if prescribed by the Licensing Authority), with testing Protocol/s, full impurity profile and release specifications.

  • All items mentioned above may not be applicable to all drugs. The items not relevant to a particular new drug should be marked with “Not Applicable (NA)”.
  • Application for both bulk as well as formulation is required to be submitted. Proposal for grant of permission to manufacture only bulk drug will be considered after approval of its formulation.

Dr. Manoj Karwa

Auriga Research Ltd.
Email: [email protected]


Did you get here from a link from a friend, or twitter? This lesson is the 2 part of 10 parts Approval of New Drugs in India online Free e-course. To get more information about free e-course and sign up Click here