New Drugs, FDCs, Clinical trial

Last Updated on August 4, 2021 by The Health Master

Tablets drug medicine
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What is new drug

Rule 122-E

Definition of new drug.-

1[(a) A drug, as defined in the Act including bulk drug substance [or phytopharmaceutical drug] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:

Provided that the limited use, if any, has been with the permission of the licensing authority.]

(b) 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.

(c) 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. (See items (b) and (c) of Appendix VI to Schedule Y.)

Explanation.- For the purpose of this rule−

(i) all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;

(ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval

Also read: FAQs about New Drug, Banned drugs etc.

About new drugs

Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country.

The Rules 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and Appendix I- XII of Schedule Y, describe the information/data required for approval of clinical trial and / or to import or manufacture of new drug for marketing in the country.


  1. Rule 122-A -Application for permission to import new drug

Rule 122-B -Application for approval to manufacture new drug

Rule 122-DA-Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;

Rule 122 DAB -Provision for examination of serious adverse event (SAE) of injury and death and payment of compensation in clinical trial related cases. Provision for debarment of the applicant in case of failure to pay compensation;

Rule 122 DAC -Conditions of permission for conduct of clinical trial which includes mandatory requirement to follow Good Clinical Practice (GCP) guidelines, guidelines and requirements specified in Schedule Y of Drugs and Cosmetics Rules and other applicable regulations. Provision for debarment of applicant and investigator in case of non- compliance

Rule 122 E-Definition of new drug

Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug

Good Clinical Practice Guidelines

Good Clinical Practice Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India

DCGI Notice dt 26-07-2021 – Evaluation of certain Pre 1988 permitted FDCs – without due approval from CLA


DCGI Circular 23-07-2021 Already approved drugs is New Drug, if certain changes occur in Active substance


DCGI Circular 08-09-2020 – regarding 294 rational FDCs – procedure to be followed

GSR 99(E) dt 05-02-2021 -Draft notification For inclusion of provisions related to the registration of stand alone bio analytical laboratories in the NDCT Rules, 2019


GSR No. 354(E) dt 05-06-2020 – Regarding New Drugs and trial (Amendment) Rules 2020 draft

DCGI Notice 17-04-20 Clinical trial of convalescent plasma in COVID-19 Patients

DCGI Notice 13-03-20 – Guidelines for approval of synthetically manufactured drugs which has been previously approved as r-DNA derived drug


DCGI Notice 13-03-20 – Requirement of CMC documents for approval of additional indication of an already approved drug product


DCGI Notice 13-03-20 – Requirement of process validation report for permission to conduct Clinical trial / BA-BE studies


DCGI Notice 13-03-20 – Testing of all categories of new drugs for their approval


DCGI has issued notice on 26-02-2020 regarding submission and processing of application for registration certificate and import license in parallel with new drug application

DCGI has issued notice on 21-02-2020 regarding pre-submission meeting for new drugs and clinical trials

DCGI has issued notice on 21-02-2020 regarding fixing of limit of impurities in the specifications of INDs

DCGI has issued notice on 21-02-2020 regarding approval of FDCs containing new drugs

DCGI has issued notice on 20-02-2020 regarding Considerations-of Honb’le Supreme Court of India in the case of 294 FDCs

FAQ dt 18-02-2020 by CDSCO on New Drugs and Clinical trial

DCGI has issued notice on 07-02-2020 regarding Pathway for subsequent manufacture of category d FDCs as per Prof. Kokate Committee Report-extension in time limit for submission of application

DCG(I) has issued a letter on 28-01-2020 regarding the procedure to be followed for subsequent application in respect of 450 FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I). To download click below link.

FAQ dt 23-08-19 CDSCO on New Drugs and Clinical Trail

FAQ dt 26-04-19 CDSCO on New Drugs and Clinical Trial

Also read: Approval procedure of 2,131 FDCs: DCGI

New Drugs and Clinical Trials Rules 2019

Earlier stability data was to be submitted only for the Patent and Proprietary drugs. Now as per the notification GSR 360 (E) dated 10.04.2018 submission of stability data of every drug (including Patent and Proprietary and drugs mentioned in IP) is mandatory while applying for approval. Click below link for notification.

List of BA / BE centre

DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019


List of new drugs

Here are the lists of new drugs which have been approved till date, Click below links to download the list of new drugs for the relevant year:

For notifications of Drugs Act, Drugs Rule and New Drugs, click below links:

Notifications – Drugs Act

Notifications – Drugs Rule

Notification – New Drugs

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