158 Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-Committee which were earlier considered as irrational in the Expert Commiteee report of the Prof.Kokate Committee 2023-Mar-31 4207 KB

File No.04-01/2013-DC(Misc. 13-PSC Part-lll) Government of India Directorate General of Health Services Central Drugs Standard Control Organization (FDC Division) ; FDA Bhawan, Kotla Road Now Delhi-110002 NOTICE Dated: “9A5 [| MAR “ee9/9 Subject: Evaluation of 16 Fixed Dose Combinations (FDCs) by DTAB Sub-committee which were earlier considered as irrational in the Expert Committee report of the Prof. Kokate committee-regarding.

The 86th meeting of the Drugs Technical Advisory Board (DTAB) was held under the Chairmanship of the Director General of Health Services. It deliberated on the report of Prof. Kokate Committee with respect to Fixed Dose Combinations (FDCs) considered as irrational in the Expert Committee report of the committee.

DTAB examined the Expert Committee report of Prof. Kokate dated 12.03.2021 in its 86"" DTAB meeting and in principle agreed to the recommendations of the Prof. Kokate Committee and recommended that the sub-committee under Dr. Nilima Kshirsagar, Emeritus Scientist, Former Chair in Clinical Pharmacology, ICMR, Mumbai, shall examine the 16 irrational FDCs in details as per the earlier procedures.

In order to give an opportunity to the manufacturers of said FDCs and the concerned stakeholders for presenting the precise data with respect to these FDCs, the Subcommittee has desired that the manufacturers and other stakeholders submit the information in the prescribed format as per Annexure ‘A’ (along with supporting documents) which is enclosed herewith for further action.

ed that the manufacturers and other stakeholders submit the information in the prescribed format as per Annexure ‘A’ (along with supporting documents) which is enclosed herewith for further action.

Accordingly, all the manufacturers of said FDCs and the concerned stakeholders are hereby requested to submit the information in the prescribed format and the relevant supporting documents in hard copy as well as soft copy (i.e. in C. D.Form) to this office latest by 30" April 2023 till 5:00 PM. ee eriarey Deputy Drugs Controller (India)

Copy to:

1. Dr. Nilima Kshirsagar, the Chairperson, Sub-Committee of DTAB

2. Indian Drug/Pharmaceuticals Association Forum

3. Website of CDSCO for information and necessary action by manufacturers of said FDCs and concerned stakeholders

Identification number as on

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)

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||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|i|a|Item|Response|
|mares|(a)|Composition|of Product|
|la.|(FDC):|
|(Details|of all|ingredients,|
|||strengths|/dosage|forms)|
|||||(c) Name|
|||and|Address|of|
|||the|Applicant|
|Whether|the|applicant|is|
|Ie|Manufacturer:|
|||||il.|Marketer|:|
|||||ui.|Any other (please|
|specify)|:|
|||Iv.|--|
|ih.|‘Licensing|authority|with|||Name and Designation of|the|licensing|Date|&|Year of|
|Meader|ee|
|||||cuboid:|to.|Liggmiag)|
|||5|| ning|Wille|barn|ee|
|“ie.|||Whether the FDC|is|
|||approved|by DCGI,|If so|
|| Whether|the|FDC|is|Pre|
|||[ld.]|details/evidence thereof|
|||||1988,|If so|details/evidence|

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|“ie.|||Whether the FDC|is| |||approved|by DCGI,|If so| || Whether|the|FDC|is|Pre| |||[ld.]|details/evidence thereof| |||||1988,|If so|details/evidence|

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S. Item Response ———ies s- eee[(including][all][active][ingredients)] se[formulation] Particulars of the drug: Dosage form, composition of the So4, Provide a copy ofthe approved Packageainsert that is ee ll ee aes5. asState perthe Drugs andcategory Cosmeticsunder which Rules. FDC approval is claimed | Pharmacological chesifcaion S| a) Therapeutic justification / rationale for each ingredient {i b) Therapeutic value claimed or purported to be claimed of the FDC (Postulated advantage/ Therapeutic value of FDC)[{Tick (V) appropriate option(s)] i Ti Reduced incidence ofadveneeMs fC Po. Sk ee Tee ee ie Rn Booserferanotierdg Pv | “Vi Improved patentadherense/ Convenience | vil Minimization ofabuse ofotheractves [| “Vil Reduced development of microbial esisance [| ik. Anyother(plemespeni) | 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 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.

dividual 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) 

! 

i 

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```text
|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|S.|Response|
|ef|
|g,|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)|
|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|thereofconcurrently|,|
|12.||—_ioa)|Whether marketed|in|EU,|UK,|Canada,|Australia,||
||b) Tes, which|countiyfeountries?|
|c)|Specify country-wise product brand|name,|ingredients,|
|dosage|form,|its|strength,|amount|of usual|ingredients|

hether marketed|in|EU,|UK,|Canada,|Australia,||
||b) Tes, which|countiyfeountries?|
|c)|Specify country-wise product brand|name,|ingredients,|
|dosage|form,|its|strength,|amount|of usual|ingredients|
|per dosage|form,|indication/s|and dosage|frequency|
|ee|
|1|||Contes|when|eg|eee|||
|[CLeea|oo|Greaa|ENeee|ae|
|eames|
|13.2|(@)|withdrawn,|any, withreasons|||
|lnateatigeret||Restrictions|on use,|if any,|in countries where||
|ialial16.|[badeiocaimeele]|eraiaeneaeeds-- °S8Se OPEats|
|[smn||Submit|one page summaryvines of groundsSvante and reasons|in|||
|T17.|||sisciccmmateearoecommineSubmit PPT of presentation|in hard copy (Maximum|7|||
|(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)|

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3

Signature of the Authorized representative:

Name: ee es ee IDESIQ MAIO! 7S See ee Se ae gee

Date:

|

Place:

sic i si enerate

;

List of 16 FDCs in 294 FDCs recommended as irrational by Prof. Kokate Committee.

:

Sino. [NameofFDC ee | Vitamin A - 6. _| Aloe vera + Jojoba oil+ Wheat germ oil +Teatreeoll ~8.| Dicyclomine + Paracetamol + Clidinium Bromide eeChlordiazepoxide

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