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.


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Subsequent New Drug Application

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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Frequently Asked Questions

What is an “orphan drug” as per the New Drugs and Clinical Trial Rules, 2019?

“Orphan drug” means a drug intended to treat a condition which affects not more than five lakh persons in India.

“New drug” means, (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) 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; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug; Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v), shall continue to be new drugs for a period of four years from the date of their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses (iv) and (v) shall always be deemed to be new drugs;

Yes. As per clause (w) of rule 2 of the New Drugs and Clinical Trials Rules, 2019 modified/sustained/prolonged/controlled release and NDDS of an approved drug are always considered as new drug and hence, require prior permission from CLA before obtaining the manufacturing license from the SLA for such products.

Any new drugs or investigational new drugs imported for the purpose of clinical trial shall be kept in containers bearing labels, indicating the name of the drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation or the centre where the clinical trial is proposed to be conducted, name and address of the manufacturer, and the purpose for which it has been imported. Where a new drug or an investigational new drug is imported by the licencee on behalf of another person, the licencee shall indicate on the label of the container of the such drug, the name and address of the importer and the person to whom it is being supplied along with the scientific name of such drug, if known, or the reference which shall enable such drug to be identified and the purpose for which it is manufactured. No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

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.

Any person or institution or organisation having permanent establishment in India who intends to conduct clinical trial study of a new drug or an investigational new drug can submit application for clinical trial study

Yes. Any sponsor or investigator intended to initiate a clinical trial for new drug or investigational new drug shall obtain permission from CLA in Form CT-06. The applicant shall submit application in Form CT-04 along with all other necessary documents specified under Second Schedule and fees as specified under Sixth Schedule of CT Rules 2019.

In general, the timeline for disposal of an application for conduct of clinical trial study is 90 working days from the date of receipt of application. However, if the drug is discovered in India or research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India then the timeline for disposal of an application for conduct of such clinical study is 30 working days from the date of receipt of application. In such case, if no response is issued by the CDSCO within 30 working days, the clinical trial will be considered to be deemed approved.

Minimum of seven members from medical, non-medical, scientific and non-scientific areas with at least, one lay person; one woman member; one legal expert; one independent member from any other related field such as social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian At least 50% of members not affiliated with the institute or organization in which EC is constituted Every member of the EC shall be required to undergo such training and development programs

An application for grant of permission to conduct clinical trial of new drug or investigational new drug shall be made in Form CT-04. The application should be accompanied by the necessary documents as specified under Second Schedule along with the fees as specified under Sixth Schedule of the NDs & CTs Rules, 2019. Order issued by CDSCO on 10th Apr 2019, Form CT-04 (and other Forms) can be manually completed and uploaded in SUGAM, till all the new Forms are integrated into the online submission portal.


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