Module 6: New Drug Application: New Indication, Dosage form or route of administration

Approval of New Drugs in India

i. 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.

In such cases regulatory authority can rely on the safety and/or efficacy data of a previously approved drug. However, additional nonclinical and/or clinical data is necessary to substantiate the new claims of the approved drug. The additional data needed for establishing the safety and efficacy of such new drugs will usually be determined on case-by-case basis depending on the type of new claims being made.

Requirements of Animal Pharmacological, Animal Toxicological & clinical data may be abbreviated / relaxed / omitted if all the below mentioned conditions are satisfied:

  1. If the drug is already approved by various agencies and is being marketed in major countries for the proposed new claim (s).
  2. There are evidences of no difference in metabolism of drug due to ethnic differences.
  3. Availability of adequate clinical data supporting the benefit-risk ratio in favor of the drug in the proposed new claim (s).
  4. The package insert from marketed countries shows that there is no added safety concern if the drug is allowed to be given to Indian patients for the new claim (s).

Requirements of Animal Toxicological & clinical data may be abbreviated / relaxed / omitted if the proposed new claim is for serious life threatening disease or disease of special relevance to Indian health scenario.

CDSCO will examine the adequacy of such applications for the purpose of granting approval for manufacture/import of such new drugs. Wherever required the matter may also be examined in consultation with experts/expert committees.

Requests for waiver of requirements of Animal Toxicological & clinical data will be examined in consultation with expert/expert committees.

ii. A drug already approved by the Licensing Authority mentioned in Rule 21 proposed to be marketed with new indication

In such cases when application is for an already approved drug which is proposed to be marketed with a new indication the documents required to be submitted are as follows:

  1. Form 44
  2. Treasury Challan of INR 50,000 / 15,000 as the case may be.
  3. Source of bulk drugs /raw materials:
  4. Chemical and pharmaceutical information including:

i. Data requirements in respect of Chemical and Pharmaceutical information may be omitted depending on whether the applicant has already obtained permission from CDSCO for the same dosage form of the new drug for approved indication. If the applicant has already obtained permission from CDSCO for the same dosage form of the new drug for approved indication, no further chemical and pharmaceutical data is required to be submitted.

ii. If the applicant has not obtained such permission, complete chemical & pharmaceutical data is required to be submitted along with the application. Details of such data required are as follows:

6. Animal Pharmacology Data (as per Schedule-Y)
7. Animal Toxicology Data (as per Schedule-Y)
8. Human / Clinical pharmacology (Phase I) Data
9. Therapeutic exploratory trials (Phase II)
10. Therapeutic confirmatory trials (Phase III)
11. Special studies
12. Regulatory status in other countries for proposed indication.
13. Prescribing information and Draft Specimen of label & Carton
14. Copy of License in Form-29

iii. A drug already approved by the Licensing Authority mentioned in Rule 21 and proposed to be marketed as a ‘new dosage form / new route of administration’.

In such cases when application is for an already approved drug which is proposed to be marketed with a new dosage form the documents required to be submitted are as follows:

  1. Form 44
  2. Treasury Challan of INR 50,000 / 15,000 as the case may be.
  3. Source of bulk drugs /raw materials.
  4. Chemical and pharmaceutical information on API
  5. Data on Formulation
  6. Animal Pharmacology Data (as per Schedule-Y)
  7. Animal Toxicology Data (as per Schedule-Y)
  8. Human / Clinical pharmacology (Phase I) Data (as per Schedule-Y)
  9. Therapeutic exploratory trials (Phase II)
  10. Therapeutic confirmatory trials (Phase III)
  11. Special studies
  12. Regulatory status in other countries
  13. Prescribing information and 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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