Module 5: New Drug Application

Approval of New Drugs in India

In all upcoming modules we have listed the required documents for different category of new drug. For ease of understanding the new drugs approval permission can be categorized as below:

  1. New Chemical Entity – developed in India as an IND and not marketed anywhere in world.
  2. New Chemical Entity approved & marketed in other countries not approved in India.
  3. New Chemical Entity being developed in other countries and not marketed anywhere in world.
  4. A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
  5. A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.
  6. New Drug already approved in the country (within four years of approval of new drugs).
  7. Import and Registration for foreign manufacturer

This module covers required data for following new drug application for

a) IND developed in India
b) Not approved in country

New Drugs – developed in India as an IND and not marketed anywhere in world.
New Chemical Entity approved & marketed in other countries not approved in India.
New Chemical Entity being developed in other countries and not marketed anywhere in world.

For such New Drugs to be approved for marketing, data required to be submitted will be similar as per Appendix I of Schedule Y which is similar to data required for any new chemical entity (NCE). For such New Drugs the clinical trials are required to be carried out right from Phase I. CDSCO will initially examine such applications, if any particular data is lacking same will be informed to the applicant or else the applications will be forwarded to the members of IND committee.

Generally, the new drugs which are approved in one or more countries like USA, UK, Canada, European Union, Japan, and Australia will be considered for approval of manufacture/import & marketing of the drug in the country unless there are specific reasons.

For such new drugs, Phase III studies need to be carried out locally primarily to generate evidence of efficacy and safety of the drug in Indian patients when used as recommended in the prescribing information. Prior to conduct of Phase III studies in Indian subjects, Licensing Authority may require pharmacokinetic studies to be undertaken to verify that the data generated in Indian population is in conformity with the data already generated abroad.
As per the provisions given in the Drugs & Cosmetics Rules requirement of submitting results of local clinical trials may not be necessary, if the drug is of such a nature that the licensing authority may in public interest decide to grant such permissions on the basis of data available from other countries.

Applicants seeking such waiver of local clinical trials of new drugs should submit formal request to CDSCO along with adequate justification and data. CDSCO will initially examine such applications, if any particular data is lacking same will be informed to the applicant or else the applications will be forwarded to the members of New Drug Advisory Committee (NDAC). Decision on requests for waiver of local clinical trials before approval of new drugs for marketing in the country will be taken as per recommendation of NDAC.

For new drug permission of such New Drugs the documents required to be submitted are as follows:

1. Form 44
2. Treasury Challan of INR 50,000.
3. Source of bulk drugs /raw materials.
4. Chemical and pharmaceutical information including:
a) Information on active ingredients
b) Data on Formulation
6. Animal Pharmacology
7. Animal Toxicology
8. Human / Clinical pharmacology (Phase I)
9. Therapeutic exploratory trials (Phase II)
10. Therapeutic confirmatory trials (Phase III)
11. Special studies if applicable
12. Regulatory status in other countries
13. Prescribing detail
a. Prescribing information Proposed full prescribing information containing the following information:
b. Draft Specimen of label & Carton
14. Copy of License in Form-29
15. Samples and Testing Protocol/s

Dr. Manoj Karwa

Head-PPM
Auriga Research Ltd.
Email: [email protected]


P.S

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