Subsequent New Drug Application



• Bulk Drug already approved in the country (approved within 4 years). • New drug (Formulation) already approved in the country (approved within 4 years). • A drug already approved and proposed to be marketed with new indication. • A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’. • A drug already approved and proposed to be marketed as a ‘Modified release dosage form’. • A drug already approved and proposed to be marketed with additional strength

Subsequent New Drug Application


A subsequent new drug means a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form. A subsequent new drug also includes a new drug already approved in the country.

Subsequent new drug application can be made for the following cases:

  • Bulk Drug already approved in the country (approved within 4 years).

  • New drug (Formulation) already approved in the country (approved within 4 years).

  • A drug already approved and proposed to be marketed with new indication.

  • A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’.

  • A drug already approved and proposed to be marketed as a ‘Modified release dosage form’.

  • A drug already approved and proposed to be marketed with additional strength

Data required to be submitted with Subsequent New Drug Applications

Documents for the Subsequent New Drug Application are submitted online through CDSCO SUGAM portal. Requirement of the data differs for subsequent application depending upon the years of approval.

Only bioequivalence data is required to be submitted for the drugs approved in India within 4 years of the first approval of the same molecule; whereas only chemical equivalence proof is required for drugs after 4 years of the first approval in India of the same molecule.

Content of Subsequent New Drug Application

1. Number and date of permission or license already granted for the approved new drug

2. Therapeutic justification for new claim- New indication or modified dosage form/new route of administration

3. Chemical and Pharmaceutical information

  • Chemical name, code name or number, if any; non-proprietary or generic name, if any, structure; physicochemical properties

  • Dosage form and its composition

  • Test specifications (a) active ingredients (b) inactive ingredients

  • Tests for identification of the active ingredients and method of its assay

  • Specifications of finished product

  • Outline of the method of manufacture of active ingredient and finished product

  • Stability data

4. Therapeutic justification for new claim or modified dosage form

5. Animal pharmacological and toxicological data

6. Clinical trial data

7. Regulatory status in other countries

8. Marketing information

  • Proposed package insert or promotional literature

  • Draft specimen of the label and carton

A. Bulk Drug already approved in the country (approved within 4 years)

Documents to be submitted in such case:

1. Name of Applicant with address

2. Name of Drug

3. Therapeutic Class

4. Date of Approval

5. Application signed by the competent authority

6. Treasury Challan of fees paid

7. For import:-Copy of drug sale license

8. Pharmaceutical & Chemical Information

  • Manufacturing Process including flowcharts detailed manufacturing procedure,

  • Complete monograph Specifications, methods of analysis including analytical method validation report, with structural elucidation data

  • Three batch Certificate of analysis

  • Stability data of three different lots ( should be presented in tabular form with details of Batch no, Batch size, Date of manufacturing, Date of initiation, Packaging details)

  • Material Safety data sheet

  • Reference product characterization

  • Draft specimen Label

9. Sub-acute toxicity data generated with the applicant’s bulk drug in two species.

10 Central Drug testing laboratories (CDTL) / Indian Pharmacopoeia Commission (IPC) test report

B. New drug (Formulation) already approved in the country (approved within 4 years).

Documents to be submitted to the regulatory bodies in this case are:

1. Application for permission to Manufacture /Import: (Purpose should be mentioned clearly)

2. Name of the applicant and address

3. Information related to the new drug including name,Composition, Dosage Form, Proposed indication and therapeutic rational for proposed dosage form

4. Details of the approval of the New Drug in the country including approved Dosage Form, composition and indication

5. Application signed and stamped by authorized personal

6. Treasury challan of fees paid

7. Copy of valid manufacturing license

8. Copy of valid Test license

9. Source of bulk drugs along with current regulatory status of the source

10. Consent letter and copy of manufacturing licence form supplier of bulk drug

11. Information on active ingredients

12. Data on Formulation

13. Regulatory status in other countries, as appropriate.

14. Bio Equivalence/Bioavailability study Protocol

15. Justification on Bio equivalence study waiver, if requested

16. In case of parenteral formulation, Sub-acute toxicity data conducted with the proposed drug formulation.

17. Submit 11 sets of technical literature (whenever applicable) (10 soft copy and one hard copy) for expert opinion.

a. A drug already approved and proposed to be marketed with new indication

Documents to be submitted include:

All the above documents as mentioned in section B except sr. no. 10 to 12, if applicant holds manufacturing or Import and marketing permission for the proposed drug product. (For Sr. no. 11: copy of proposed package inserts and draft specimen of Label and carton should be submitted)

In addition, following documents should be submitted:

  • Clinical trial protocol (in case of proposed additional dosage form is not approved in key countries)

  • Justification on clinical trial waiver, if requested

  • Published report of Clinical trial/ Journal/literature with respect to proposed additional information

b. A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’

In addition to documents mentioned in section B, Bio-equivalence study requirement, justification for the dosage form and New route Administration and documents related to animal toxicological data should be submitted.

c. A drug already approved and proposed to be marketed as a ‘Modified release dosage form’

  • In addition to the document in Section B, along with published report of clinical trial/journal/ Literature with respect to proposed Modified Dosage form

  • And in case of injectable formulation only sub-acute toxicity data conducted with the applicant drug formulation need to be submitted instead of the entire animal toxicological test.

Clinical Trial Requirement

Just like New drugs, for subsequent new drug application, applicant needs to conduct phase I, Phase II and Phase III trial and submit the data to the Central Licensing Authority for marketing authorization as per the “New Drugs and clinical trial rules 2019”. After getting permission to market the drug, phase IV needs to be conducted.

Clinical trial shall be initiated at the site only after getting approval letter by the registered Ethics Committee. Approval granted by the Ethics Committee shall be informed to the Central Licensing Authority within fifteen working days.

Clinical trial needs to be registered with the Clinical Trial Registry before enrolling the first subject for the trial.

Six monthly status report of each clinical trial should be submitted electronically to the Central Licensing Authority through SUGAM portal.

In case of serious adverse event (SAE), analysis report for SAE should be submitted to Central Licensing Authority and Ethics Committee within 14 days of its occurrence

Cliniexperts can help navigate through the numerous regulations and steps involved in subsequent new drug application. CliniExperts provide full spectrum services for the following types of Drug Clinical Trials:

  • Local Clinical Trial -

    Phase I Trial

    ,

    Phase II Trial

    ,

    Phase III Trial

    and Phase IV Trial or Post Marketing Studies (PMS) (exclusively in India)

  • Global Clinical Trial -

    Phase I Trial

    ,

    Phase II Trial

    and Phase III Trial

References

  • Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry Of Health & Family Welfare Govt. Of India. Available at
    https://cdsco.gov.in/opencms/opencms/en/Drugs/Subsequent-New-Drugs
    for subsequent new drug. Accessed on: 21 April 2020.

  • New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019).



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