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

F. No. 04-01/2013-DC (Misc. 13-PSC Part III) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (FDC Division) FDA Bhawan, Kotla Road, New Delhi NOTICE Dated: 0 JoL ai‘s Subject:- Evaluation of Fixed Dose combinations (FDCs) by DTAB Su- Committee which were earlier considered as irrational in the assessment report of the Prof. Kokate Committee reg- Sir, This is in continuation to this office notice 4-01/2013-DC (Misc. 13-Part III) dated 29.05.2019 on the subject cited above whereby all the manufacturers/stakeholders were requested to submit the information in the prescribed format as per Annexure A by 30" June 2019 till 5:00 P.M. for further action. In this regard, various representations have been received requesting for further extending the timeline for submission of the information. The issue was considered and it has been decided that manufacturers/stakeholders may be permitted to submit the information in the prescribed format by 16.08.2019. In view of above, all the manufacturers/stakeholders may note that the date for submission of information in the prescribed format is extended upto 16.08.2019 till 5:00 p.m. D ’ (Sanjeev mar) Convener Encl: As above Sub-Committee of DTAB To:- 1. Indian Drug/Pharmaceuticals Association Forum 2. Web site of CDSCO for information and necessary action by manufacturers of said FDCs and concerned stakeholders. Copy to: 1. Dr. Nilima Kshirsagar, the Chairperson, Sub-Committee of DTAB 2. Drugs Controller General (|), Central Drugs Standard Control Organization, FDA Bhawan, Kotla Road, New Delhi-110002 Copy for information to: Directorate General of Health Services, Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.File No. 4-01/2013-DC (Misc. 13 PSC Part Il) Directorate General of Health Services Office of Drugs Controller General (India) (FDC Division) FDA Bhawan, Kotla Road New Delhi-110002 Dated: $ Q MAY 2019 . NOTICE ‘ Subject: acE sova sml m eu i sa t st t mi e eo en n t wo rf h e pi ocF rhi tx e owd f e tr hD e eo s Pre e oa fr .lC io Kem r o b ki acn toa ent s ci i oo d mn e ms r i e td t( eF eD a -C s rs e) g i ar rb r day t i i noD gn .aT lA B i n Su tb he- 2° ApriT l h 2e 0 18 92 " u nm de ee rt i tn hg e o Cf h at ihe r mD ar nu sg hs i pT e oc fh tn hi ec a Dl i rA ed cv ti os ro r Gy e nB eo ra ar ld o( f D HT eA aB lt) h w Sa es rv h ice el sd . on It Cde ol mi bb ie nr aa tte id o no sn (t Fh De C sr )e po cr ot n so if d ePr ro ef d. 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Dr. Nilima Kshirsagar, the Chairperson, Sub-Committee of DTAB 2. Indian Drug/Pharmaceuticals Association Forum 3. FWe Db Cs si t ae n dof cC oD ncS eC rnO e dfo r s ti an kf eo hr om la dti eo rn s and necessary action by manufacturers of saidAnnexure A - May 2019 FDC Identification number as on the website: Version 1 dated 17.05.2019 Format for submission of information on FDC to DTAB Sub-Committee (Submit all the information including full text of references as hard copy as well as soft copy) S. Item Response No. (a) Composition of Product la. (FDC): (Details of all ingredients, strengths /dosage forms) (b) Brand name/s if any: (c) Name and Address of the Applicant Whether the applicant is i. Manufacturer: ii, | Marketer : iii. Any other (please specify) : iv. -- Ib. | Licensing authority with | Name and Designation of the licensing Date & Year of year of license and Authority Product License informations, if any submitted to Licensing Authority while obtaining the License Ic. | Whether the FDC is approved by DCGI, If so details/evidence thereof ld. | Whether the FDC is Pre 1988, If so details/evidence thereofS. Item Response No. 2. Particulars of the drug: Dosage form, composition of the formulation (including all active ingredients) 3; Indication(s) 4. Provide a copy of the approved Package insert that is currently provided 5: State the category under which FDC approval is claimed as per Drugs and Cosmetics Rules. 6. Pharmacological classification a) Therapeutic justification / rationale for each ingredient 7. and quantity contained in the FDC b) Therapeutic value claimed or purported to be claimed of the FDC (Postulated advantage/ Therapeutic value of FDC)[Tick (V) appropriate option(s) ] i. Increased efficacy ii. | Reduced incidence of adverse effects iii. | Dose reduction iv. Reduced cost v. Booster for another drug vi. Improved patient adherence/ Convenience vii. Minimization of abuse of other actives viii. | Reduced development of microbial resistance ix. _ Any other (please specify) c) Submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five relevant full text articles in peer-reviewed journals/ relevant information from textbooks 8. Pharmacokinetic/ pharmacodynamics rationality with half-life details of individual ingredients, dosage schedule of individual drugs and dosage schedule of FDC (Submit a one-page summary with highest level of evidence, supporting the claim of _ postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five most relevant full text articles in peer-reviewed journals/ relevant information from textbooks)S. Item Response 9. Published data regarding safety and efficacy of FDC (Submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five most relevant full text articles in peer-reviewed journals/ relevant information from textbooks) 10. | Safety & Efficacy data if any, regarding the FDC, generated by the applicant (Submit a one-page summary. Also submit the article based on these data, if published or one-page abstract of each study if unpublished with CTRI number if available) 11. | Please specify the guidelines National/international/ professional Association/Chapters/bodies) if any, that have recommended the use of the above FDC or use of the ingredients thereof concurrently 12. | a) Whether marketed in EU, UK, Canada, Australia, Japan and the USA? b) If yes, which country/countries? c) Specify country-wise product brand name, ingredients, dosage form, its strength, amount of usual ingredients per dosage form, indication/s and dosage frequency 13. | Regulatory status of the FDC in other countries 13.1 | Countries where the drug is: (a) Marketed (b) Approved (c) Approved as IND (d) withdrawn, if any, with reasons 13.2 | Restrictions on use, if any, in countries where marketed/approved 14. | Specimen of labels and cartons 15. | Any other relevant information 16. | Submit one page summary of grounds and reasons in support of FDC with not more than 5 relevant references 17. | Submit PPT of presentation in hard copy (Maximum 7 slides) which the company will present to the committee (Note: Individual Form shall be submitted for each FDC and all above information shall be provided for each strength/ dosage in the same Form of FDC) 3Signature of the Authorized representative: Name: Designation: Date: Place: For Office Use: Identification No.