Last Updated on April 11, 2023 by The Health Master
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Notifications: New Drugs, FDC, Clinical Trial
Other details about New Drugs, FDCs, Clinical trial
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.
RULES GOVERNING CLINICAL TRIALS
- 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
FDCs – Fixed Dose Combinations
DCGI dt 18-11-2022 Procedure to be followed for subsequent in respect of FDCs declared as rational by prof. Kokate Committee
DCGI Notice dt 26-07-2021 – Evaluation of certain Pre 1988 permitted FDCs – without due approval from CLA
DCGI Circular 08-09-2020 – regarding 294 rational FDCs – procedure to be followed
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
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-Guidelines-for-approval-of-synthetically-manufactured-drugs
DCGI Notice 13-03-20 – Requirement of CMC documents for approval of additional indication of an already approved drug product
DCGI has issued notice on 21-02-2020 regarding fixing of limit of impurities in the specifications of INDs
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.
DCGI dt 27-02-2019 procedure to be followed for regularisation of FDCs declared rational in respect of 294 FDCs by DTAB
Also read: Approval procedure of 2,131 FDCs: DCGI
List of Approved FDCs – Fixed Dose Combinations
Here are the lists of fixed dose combinations (FDCs) which have been approved by DCGI till date, Click on the links below to download the list of approved FDCs for the relevant year:
2023
Fixed dose combinations – Updated List of 2610 FDCs as on 05-04-2023
2022
2021
2020
2061 to 2019
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.
DCGI Circular 23-07-2021 Already approved drugs is New Drug, if certain changes occur in Active substance
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 – 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-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
FAQs on New Drugs and Clinical trial
FAQ dt 18-02-2020 by CDSCO on New Drugs and Clinical trial
FAQ dt 23-08-19 CDSCO on New Drugs and Clinical Trail
FAQ dt 26-04-19 CDSCO on New Drugs and Clinical Trial
FAQs by CDSCO on Pharma, Cosmetics, MDR, Clinical Trial
FAQs by CDSCO on Pharma, Cosmetics, MDR, Clinical Trial
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
Draft policy for approval of new drugs
CDSCO 25-11-2022 Draft policy for approval of new drugs, click the link below to downlaod:
List of new drugs
Here are the lists of new drugs which have been approved till date, Click on the links below to download the list of new drugs for the relevant year:
For notifications of Drugs Act, Drugs Rule and New Drugs, click below links:
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