Fixed Dose Combination

Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s). FDCs can be divided into the following groups and data required for approval for marketing is described below:

  1. The first group of FDCs includes those in which one or more of the active ingredients is a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials) [see rule 122E, item (a)].
    • The second group FDCs includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature [see rule 122E, item (c)]. If clinical trials have been carried out with the FDC in other countries, reports of such trials should be submitted. If the FDC is marketed abroad, the regulatory status in other countries should be stated. (see Appendix I, item 9).
    • For marketing permission, appropriate chemical and pharmaceutical data will be submitted. In case such a combination is not marketed anywhere in the world but these drugs are already in use concomitantly (not as an FDC but individually) for the said claim, marketing permission may be granted based on chemical and pharmaceutical data. Data showing the stability of the proposed dosage form will also have to be submitted.
    • For any other such FDCs, clinical trials may be required. For obtaining permission to carry out clinical trials with such FDCs a summary of available pharmacological, toxicological and clinical data on the individual ingredients should be submitted, along with the rationale for combining them in the proposed ratio. In addition, acute toxicity data (LD 50) and pharmacological data should be submitted on the individual ingredients as well as their combination in the proposed ratio.
  2. The third group of FDCs includes those which are already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim. For such FDCs, the appropriate rationale including published reports (if any) should be submitted to obtain marketing permission. Permission will be granted depending upon the nature of the claim and data submitted.
  3. The fourth group of FDC includes those whose individual active ingredients (or drugs from the same class) have been widely used in a particular indication(s) for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience. It will have to be demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a pharmacodynamic or pharmacokinetic nature. No additional animal or human data are generally required for these FDCs, and marketing permission may be granted if the FDC has an acceptable rationale.

RULES GOVERNING FIXED DOSE COMBINATIONS

The clinical trials are conducted in accordance with the Drugs and Cosmetics Rules. The specific Rules are-

  1. Rule 122 D -permission to import or manufacture fixed dose combination
  2. Rule 122 DA -Mandatory requirement of permission from DCG (I) for conduct of clinical trial of new drug;
  3. 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;
  4. 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;
  5. Rule 122 DD -Requirements and guidelines for registration of Ethics Committee;
  6. Rule 122 E-Definition of new drug;
  7. Schedule Y-Detailed guidelines and requirements for conduct of clinical trial and approval of new drug
  8. FDC Draft Guidelines -issued by CDSCO, Directorate General of Health Services, Govt. of India
  • Evaluation of applications for, finished formulations approval, Additional dosage form, modified dosage form, Additional indication, additional strength and additional route of administration for the purpose of manufacture and marketing/ import and marketing in India and also processing of applications for Clinical Trials, review, approval and follow-up until end of study as per Schedule Y, Rule 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945)
  • Review and approval of Test License applications (Form 12) to import the Investigational Medicinal Products (IMP) for BA/BE and Clinical Trials.
  • Conducting various expert committee meetings
  • Handling of complaints, parliament questions and RTI queries related to Fixed Dose Combination.
  • Data-base management (receipts/files/other misc. data including permissions generated, maintenance of guard files of query/approvals, parliament questions answered, etc.)

Currently there is no data available.

S.no Title Release Date Download Pdf Pdf Size
1 System of preliminary scrutiny by C.D.S.C.O at the time of receipt of application for approval of Fixed Dose Combinations ( 27 Jul 2012 ) 2014-Jan-04 198 KB
S.no Title Release Date Download Pdf Pdf Size
1 List of FDCs (under category 'c') permitted for continu ed manufacturing and marketing under 18 month policy decision dated 11.12.2018 2018-Dec-11 321 KB
S.no Title Release Date Download Pdf Pdf Size
1 Procedure for regularisation of FDCs w.r.t. payment of fees regarding 2019-Dec-05 345 KB
2 Manufacturing and marketing of FDC of Aceclofenac 100mg + Drotaverine Hydrochloride 80mg tablet-regarding 2019-Sep-19 503 KB
3 Notice regarding Consideration of the directions of Hon'ble Supreme Court of India in case of 294 FDCs 2019-Aug-27 233 KB
4 Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I)-regarding 2019-Aug-19 56 KB
5 Notice regarding Evaluation of Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier considered as irrational in the assessment report of the Prof. Kokate Committee 2019-Jul-01 1660 KB
6 Notice regarding Evaluation of FDC by DTAB Sub-Committee which were ealier Considered as irrational in the assessment report of the Prof.Kokate Committee 2019-May-29 768 KB
7 Procedure to be followed for subsequnt applicants in respect of FDCs falling under category 'd' as per Prof. Kokate Committee report (i.e. FDCs which require generation of data)-regarding 2019-May-22 1110 KB
8 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs in respect of FDCs which require further generation of data 2019-Apr-12 396KB
9 Procedure to be followed for subsequent applicants in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2019-Apr-12 312KB
10 Consideration of Directions of Hon'ble Supreme Court of India in the case of 294 FDCs-regarding 2019-Apr-12 7,670KB
11 Condition for supply of Buprenorphine 2mg/0.4mg sublingual tablet and FDC of Buprenorphine+Naloxone sublingual tablets 2019-Mar-28 1098 KB
12 Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Pro. Kolate Committee and approved by DCG(I) 2019-Mar-20 432 KB
13 Procedure to be followed for regularisation of FDCs declared as rational in respect to 294 FDCs by the DTAB which were licensed to manufacture and market by State Licensing Authority without prior approval from DCG(I) 2019-Feb-27 679 KB
14 Manufacture and market FDC of Atenolol+Losartan+Hydrochlorthaizide 2019-Feb-25 1430 KB
15 Public notice regarding Consideration of orders of High Court of Karnataka dated 14.08.2013 &24.07.2017 to examine the issue of safety and efficacy of Fixed dose combination of Flupenthixol +Melitracin for human use in light of notifications G.S.R. 377(E) dated 18.06.2013 & G.S.R. 498(E) dated 11.07.2014 and to provide hearing to the petitioners/manufacturers 2019-Feb-13 1297 KB
16 Prohibition of 80 fixed Dose combinations by the Central Government vide Gazette notification nos S.O 180 (E) to S.O 259 (E) 2019-Jan-22 351 KB
17 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
18 DTAB Committee Meeting from 5 June,2018 till 22 June,2018 2018-Jun-06 302KB
19 Public Notice regarding Meeting of DTAB sub Committee w.ef 05.06.2018 to 22.06.2018 in the office of DCGI to examine the344 FDCs+05 FDCs and to provide hearing to the petitioners/appellants reg.28.5.2018 2018-May-28 6,757KB
20 Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344 FDCs+05 FDCs probibited Vide S.O No. 705(E) to 1048(E) dated 10.03.2016 and S.O. No. 1851 (E) to 1855 (E) dated 08.06.2017 and Consitution of a sub-committee for having a relook in these cases 2018-May-24 2,322KB
21 Meeting of DTAB sub Committee for examining the 344 FDCs+05FDCs and to provide hearing to the petitioner/appellants including AIDAN regarding 2018-May-24 342KB
22 Notice regarding consideration of the directions of Hon'ble SC India in the Case of 344 FDCs+05 FDCs probibited Vide S.O No. 705(E) to 1048(E) 2018-Apr-20 378KB
23 Notice regarding consideration of the directions of the Hon'ble Supreme Court of India in the Case of 344 FDCs + 05 FDCs prohibited vide S.O.no. 705 (E) to 1048(E) dated 10.3.3.2016 and S.O No. 1851 (E) to 1855 (E) dated 08.06.2017 and Constitution of a sub-Committee for having a relook in these cases 2018-Mar-12 1.02MB
24 NOTICE regarding Procedure to be followed for subsequent applicants in respect of FDCs declared as rational by Kokate Committee and approved by DCGI 2017-Oct-05 314KB
25 NOTICE regading Supreme court hearing in the matters relating to FDC 2017-Sep-07 8.02MB
26 Notice regarding Pocedure to be followed for subsequent application in respect of FDCs declared as rational by Kokate Committee and approved by DCG(I)Notice regarding Pocedure to be followed for subsequent application in respect of FDCs declared as rational by Kokate Committee and approved by DCG(I) 2017-Jun-05 416KB
27 Notice regarding Examination for safety and efficacy of FDCs Licensed for manufacture for sale in the country without due approval form DCG(I) 2017-Jun-05 386KB
28 Notice regarding Procedure to be followed for subsequent applicant in respect of FDCs declared as rational by Prof. Kokate Committee and approved by DCG(I) 2017-Mar-16 704kb
29 Notice regarding Examination for safety and Efficacy of FDCs licensed for manufacture for sale in country without due approval form office of DCG(I) 2017-Mar-01 349kb
30 Office memorandum regarding approval of the safety and efficacy of FDCs 2016-Oct-26 320KB
31 Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I) 2016-Oct-17 338KB
32 Notice Order regarding Examination of Safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from DCG(I) 2016-Oct-14 373KB
33 Notice regarding Examination for safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from office of DCG(I) 2016-Sep-01 310KB
34 Notice regarding Examination for safety and Efficacy of FDCs 2016-Jun-17 310KB
35 Notice dated 12.05.2016 regarding FDC Court cases pending before the Delhi High Court alongwith notification wise list of matters 2016-May-12 1,050KB
36 Prohibition of Fixed Dose Combination of drugs for human use under Section 26A of Drugs & Cosmetics Act, 1940 2016-Mar-12 147KB
37 Office Order 2015-Feb-16 300Kb
38 Order Dated 06.02.2013: "Expert Committees to formulate Policy Guidelines and SOPs for approval of new Drugs clinical trials, banning of drugs and FDCs" 2013-Feb-06 790KB
S.no Title Release Date Download Pdf Pdf Size
1 2019.01.11_S.O. 180(E) to S.O.259(E)_Prohibition of certain FDCs appeared in the list of 294 FDCs, under Section 26A 2019-Jan-11 1964 KB