Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

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 newdrug_advisory_commitee 2018-Feb-09 4796kb
2 Circular Regarding Approval of Safety and Efficacy Marketed in the Country of FDC Without Approval from DCG(I) 2014-Feb-03 323 KB
3 Updated Package Insert PI for empagliflozin Tablets 10mg and 25mg based on company Core Data Sheet (CCDS) 2014-Jan-04 60 KB
4 Draft guidance on approval of clinical trials & new drug 2014-Jan-04 643 KB
5 Draft Guidelines For Industry on Reporting Serious Adverse Events occurring in Clinical Trials ( 27 Jul 2012 ) 2014-Jan-04 415 KB
6 FAQ on Phytopharmaceutical Drugs 2014-Jan-04 372 KB
7 Twelve New Drug Advisory Committees (NDAC) ( 27 Jul 2012 ) 2014-Jan-04 4796 KB
8 Approved for Marketing in India 2013-Nov-27 433 KB
9 Report of Prof. Ranjit Roy Chaudhury Expert Committee 2013-Jul-23 826 KB
10 Draft Guidance for Industry on requirement of Chemical & Pharmaceutical Information including Stability Study data before Approval of Clinical Trials / BE Studies ( 27 Jul 2012 ) 2012-Jul-27 2599 KB
11 Draft Guidance for Industry on Fixed Dose Combinations 2010-Aug-20 422 KB
S.no Title Release Date Download Pdf Pdf Size
1 DRAFT POLICY FOR APPROVAL OF NEW DRUGS 2022-Nov-25 583 KB
2 Guidance CMC & Stability Data 2018-Feb-09 2599kb
S.no Title Release Date Download Pdf Pdf Size
1 Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient with gBRCA mutution and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy 2024-May-16 768 KB
2 Guidelines for approval of synthetically manufactured drug which has been previously approved as r-DNA derived drug. 2020-Mar-13 43 KB
3 Testing of all categories of new drugs for their approval 2020-Mar-13 47 KB
4 Requirement of process validation report for permission to conduct Clinical trial BA-BE studies. 2020-Mar-13 52 KB
5 Requirement of CMC documents for approval of additional indication of an already drug product 2020-Mar-13 45 KB
6 Notice regarding Fixing of limit of impurities in the specification of INDs 2020-Feb-21 347 KB
7 Notices for Streamlining Applications for New Drugs, Clinical Trials and Bioavailability/ Bioequivalence (BA/BE) Studies/ grant of COPP 1.Permission to conduct BA/BE study and Clinical trial. 2.Approval of FDCs containing new drugs. 3.Fixing of limit of impurities in the specification of INDs. 4.Pre-submission meeting. 5.Sub-acute toxicity study report for injectable products for BA/BE study in human for export. 6.Requirement of Stability Data for COPP 2020-Feb-21 9066 KB
8 Notice regarding Grant of Permission in Form CT-11/ CT-14/CT-15/ CT-17 under New Drugs and Clinical Trials rules 2019 2020-Feb-20 254 KB
9 Notice regarding New Drugs dated 18.02.2020 2020-Feb-18 943 KB
10 Notice regarding the FAQs on New Drugs and Clinical Trial dated 18/2/2020 2020-Feb-18 893 KB
11 Additional FAQ on New Drugs and Clinical Trial Rules, 2019 2019-Aug-23 152 KB
12 Frequently Asked Questions (FAQs) on New Drugs and Clinical Trials 2019-Apr-26 478 KB
13 Safety warning for SGLT2 Inhibitors 2019-Mar-25 9560 KB
14 Draft Guidelines for Evaluation of Nanopharmaceuticals in India 2019-Mar-07 31990 KB
15 Notice regarding sale of medicines without prescription 2018-Dec-15 84 KB
16 Filing of applications of New Drugs, FDC and SND through ‘SUGAM’ Portal only– Reg 2018-Jun-11 359KB
17 Confirmation of Drugs Inspectors after satisfactorily completion of probation period of 02 Years in CDSCO 2018-May-01 548KB
18 Notice regarding SUGAM for New Drugs FDC and SND 2018-Apr-27 372KB
19 Office Order regarding constitution of Indian Drug/Pharmaceuticals Association Forum 2018-Mar-14 295KB
20 FDC Guidelines _ Revised1 2018-Feb-23 422kb
21 Order regarding creation of 'Ayush' vertical in CDSCO 2018-Feb-05 734KB
22 Notice regarding Invitation for Inclusion of Professionals in the Subject Expert Committee Panels under CDSCO 2017-Nov-21 1.96MB
23 NOTICE regarding the SLP No.7061/2017 titled under Union of India Vs Pfizer and Ors and other connected matter relating to FDC drugs Cases Pending before the Hon'ble Supreme Court 2017-Sep-15 238KB
24 NOTICE regarding System of consultation meetings for cases of drug development of National Laboratories 2017-Sep-12 566KB
25 Notice regarding grant of licence for manufacture of new drugs including FDCs without prior approval from DCG (I) 2017-May-16 471KB
26 Public Notice regarding D-Penicillamine 2017-Feb-10 44.6KB
27 Notice regarding 32 meeting of the Apex Committee held on 03.11.2016 2017-Jan-17 47.6KB
28 Non availability of life saving drug(D-Penicillamine) across India-Regarding 2016-Sep-28 43KB
29 Office Order dated 03.07.2014 - Consideration of ethnicity for approval of new drugs 2014-Jul-03 211KB
30 Office Order 2013-Apr-16 391KB
31 Clarification with respect of the manufacturing and marketing of New Drugs 2011-Mar-10 300 KB
32 Cellular Biology Based Therapeutic Drug Evaluation Committee (CBTDEC) 2010-Sep-01 1248 KB
S.no Title Release Date Download Pdf Pdf Size
1 New Drugs and Clinical Trials Rules 2019 G.S.R. 227(E) 2019-Mar-20 3456 KB
2 CTD Guidance Final 2018-Feb-09 816kb