72 Examination of 2nd assessment report of Prof. Kokate Committee by Drugs Technical Advisory Board (DTAB) in its meeting dated 26.09.2022 2025-Apr-11 3102 KB

File No. 4-01/2013-DC (Misc. 13-PSC) (Pt. III) Govt. of India Directorate General of Health Services Central Drugs Standard Control Organization (FDC Division)

FDA Bhawan, Kotla Raod, New Delhi-110002 Dated:

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----- Start of picture text -----<br> NOTICE<br>----- End of picture text -----<br>

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Subject: Examination of 2nd assessment report of Prof. Kokate Committee by Drugs Technical Advisory Board (DTAB) in its meeting dated 26.09.2022-regarding.

This is with reference to this office letter dated 15.01.2013 whereby all the State/UT Drugs Controllers were requested to ask the concerned manufacturers in ' their State to prove the safety and efficacy of FDCs within 18 months which were permitted by State Licensing Authorities without due approval from the office of DCG(I).

Prof. Kokate Committee submitted its 2nd assessment report to the Central Government on the remaining FDCs which could not be assessed in the first lot. Based on the recommendations of the Kokate Committee, the FDCs declared as irrational were referred to the Sub-Committee of DTAB through the DGHS, Chairperson DTAB vide order no. 18-04/2019-DC dated 12.04.2019.

The DTAB Sub-Committee under the Chairmanship of Dr. Nilima Kshirsagar submitted its report on 28.12.2021 after holding a series of meetings as well as by providing hearing to the stakeholders, which was placed before DTAB in the 88" meeting held on 26.09.2022 wherein, the Committee after detailed deliberation considered following 01 FDC as rational with certain conditions: -

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olders, which was placed before DTAB in the 88" meeting held on 26.09.2022 wherein, the Committee after detailed deliberation considered following 01 FDC as rational with certain conditions: -

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public notice theena |[ aeesieemene] | ae Chlorxylenol 4.80 % w/v| After detailed deliberation, the Committee declared +Terpinol 9.0% v/v +1 the FDC of Chlorxylenol 4.80 % w/v +Terpinol v/v (Denatured) Gel Gel as rational with the following specific condition that : “Firm should clearly mention do’s and dont’s for use of the formulation in the package insert and accordingly the revised package insert shall be lm submitted.”

Accordingly, with the approval of the Ministry of Health and Family Welfare, it has been now decided to follow the following pathway for grant of product license by SLAs for above mentioned FDC:

1. Applicants shall submit the requisite fees preferably through Bharatkosh for FDC to CDSCO as specified in Sixth Schedule of New Drugs and Clinical Trial Rules, 2019.

2. The applicant shall submit application to the concerned State Licensing Authorities (SLA) as per the provisions of Drugs and Cosmetics Rules 1945

for grant of product manufacturing license giving the details of FDC, stability studies data (06 months accelerated), Test Specification of the FDC along with Method of Analysis as well as label and other documents as required for grant of product license under Drugs and Cosmetics Rules.

a (06 months accelerated), Test Specification of the FDC along with Method of Analysis as well as label and other documents as required for grant of product license under Drugs and Cosmetics Rules.

3. State Licensing Authority (SLA) shall grant the product license of such FDC without NOC from DCG (I), if conditions of license under the Drugs and Cosmetics Rules, which need to be verified by SLA, are found to have been fulfilled. The SLAs shall verified the quality of such FDC of each applicant/manufacturer, before grant of license.

4. Every manufacturer permitted to manufacture said FDC shall submit the periodic safety update reports (PSURs) as per New Drugs and Clinical Trial

Rules, 2019 to the Central Licensing Authority as defined in Rule ‘3’ i.e. DCG(I). Failure to submit the PSURs shall be considered as contravention of these Rules.

5. Manufacturers shall comply with the recommendation of the expert committee w.r.t. revision of the prescribing information/label.

In view of above, you are requested to ask the concerned stakeholders to follow the above procedure for obtaining the manufacturing license w.r.t. above FDC declared as rational.

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----- Start of picture text -----<br> Yours faithfully,<br>(Dr. Rajeev Si aghuvanshi)<br>D ;<br>----- End of picture text -----<br>

To:-

• All State/UT Drugs Controllers/All Zonal/Sub Zonal offices of CDSCO. Copy to:1. PPS to Secretary/AS(F&D)/JS(R), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.

---**<br>

To:-

• All State/UT Drugs Controllers/All Zonal/Sub Zonal offices of CDSCO. Copy to:1. PPS to Secretary/AS(F&D)/JS(R), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.

• 2. Drug Manufacturing Associations/Website of CDSCO.

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File No. 4-01/2013-DC (Misc. 13 PSC Part Ill) Govt. of India Directorate General of Health Services Central Drugs Standard Control Organization (FDC Division)

FDA Bhawan, Kotla Road New Delhi-110002 Dated: n 11 APR 202

NOTICE

Subject:-: Examination of 2nd assessment report of Prof. Kokate Committee by Drugs Technical Advisory Board (DTAB) in its meeting dated 26.09.2022-regarding. This is with reference to this office letter dated 15.01.2013 whereby all the State/UT Drugs Controllers were requested to ask the concerned manufacturers in their State to prove the safety and efficacy of FDCs within 18 months which were permitted by State Licensing Authorities without due approval from the office of DCG(I).

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----- Start of picture text -----<br> ;<br>----- End of picture text -----<br>

Prof. Kokate Committee submitted its 2nd assessment report to the Central Government on the remaining FDCs which could not be assessed in the first lot. Based on the recommendations of the Kokate Committee, the FDCs which were declared as irrational were referred to the Sub-Committee of DTAB through the DGHS, Chairperson DTAB vide order no. 18-04/2019-DC dated 12.04.2019.

The DTAB Sub-Committee under the Chairmanship of Dr. Nilima Kshirsagar submitted its report on 28.12.2021 after holding a series of meetings as well as by meeting held on 26.09.2022 wherein, the Committee after detailed deliberation recommended for generation of data w.r.t. following 06 FDCs: -

12.2021 after holding a series of meetings as well as by meeting held on 26.09.2022 wherein, the Committee after detailed deliberation recommended for generation of data w.r.t. following 06 FDCs: -

||SS<br>Dosage form|SS<br>Dosage form|SS<br>Dosage form|SS<br>Dosage form|
|---|---|---|---|---|
||2|Heparin|Sodium IP 50 IU + |To conduct Phase-IV Clinical trial to show||
|||Benzyl|Nicotinate<br>2mg<br>+/||efficacy and<br>safety of the<br>product,<br>with|
|||.|Sorbic|Acid<br>1.97<br>mg]|efficacy<br>as<br>the<br>primary<br>objective<br>in|
|||(Preservative)<br>per<br>gm|||statistically significant number of patients.|
|||ointment||Protocol should be approved by SEC and|
|||||study should be completed within one year|
||2.|Ketoconazole IP 2.00 %w/v|||To<br>conduct<br>double<br>blind<br>clinical<br>trial|
|||+<br>Shale<br>Oil<br>Sulfonate|||comparing Ketoconazole alone with<br>this|
|||(Ichthyol pale) 0.50%w/v +|FDC<br>to show superiority<br>of FDC over<br>D-Panthenol BP 0.2%w/v + |Ketoconazole<br>alone<br>for<br>treatment<br>of<br>"<br>:<br>condition mentioned in the indication and<br>Aloevera 1% wivShampoo | thus providing therapeutic justification for|||
|||||the<br>ingredients<br>contained<br>in<br>this<br>FDC.|
|.||||Protocol should be approved by the SEC|
|||||and study should be completed within one|
|||||ear.|

;

tic justification for||| |||||the<br>ingredients<br>contained<br>in<br>this<br>FDC.| |.||||Protocol should be approved by the SEC| |||||and study should be completed within one| |||||ear.|

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```text
|ES <br>3.|PE<br>ee<br>Propranolol<br>hydrochloride |To<br>conduct Phase<br>IV<br>Clinical<br>Trial<br>to|
|---|---|
||20mg/20mg/40mg<br>-<br>+]<br>evaluate efficacy and safety of the FDC in|
||Etizolam<br>comparison with Etizolam, with efficacy as|
||0.25mg/0.5mg/0.5mg<br>the<br>primary<br>objective<br>in<br>statistically|
||Tablets<br>significant<br>number<br>of<br>patients<br>for<br>the|
||indication as approved bySEC. The Clinical|
||Trial protocol must receive approval of the|
||SEC and the study must be completed|
||within one<br>year.|
|4.|Glucosamine<br>sulphate |To conduct<br>non-inferiority,<br>double<br>blind,<br>(added<br>as<br>glucosamine |comparative<br>Phase<br>IV<br>Study<br>wherein,<br>sulphate<br>sodium<br>chloride)|efficacyofthisFDC (Glucosamine Sulphate|
||500mg<br>+<br>Chondroitin |potassium<br>chloride 500mg<br>+Chondroitin<br>Sulphate 400mg (added as| Sulphate400mg gelatincoated tablet) given<br>chondroitin sulphate sodium)| three times a day should be compared with|
||film coated tablets<br>FDC of Glucosamine Sulphate potassium|
||chloride 750mg<br>+<br>Chondroitin<br>Sulphate|
||600mg gelatin coated tablet given twice a|
||day.

es a day should be compared with|
||film coated tablets<br>FDC of Glucosamine Sulphate potassium|
||chloride 750mg<br>+<br>Chondroitin<br>Sulphate|
||600mg gelatin coated tablet given twice a|
||day. The Protocol should be approved by|
||the SEC and study should be completed|
||within one<br>year|
|5.|Taurine<br>500mg<br>+_<br>N-|<br>After detailed deliberation, the Committee<br>Acetylcysteine<br>150mg<br>film |recommended<br>that firms<br>in<br>the current|
||coated tablets<br>scenariowhile continuingthe manufacturing|
||and marketing are required to conduct a|
||well-designed structured Phase IV Clinical|
||trial<br>in<br>adequate<br>sample<br>size<br>keeping|
|elliCa<br>=.<br>DiiMary ODJe<br>><br>and<br>e<br>| |<br>should be completedwithin one year.<br>Flupirtine<br>maleate<br>+ |To conduct Active PMS Study on this FDC.<br>Thiocolchicoside IP (100mg|The study should be completed within one<br>+4mg & 100mg +8mg) film | year.||
||coatedtablets|

With the approval of Ministry, it has been now decided to follow the pathway for clearance of such subsequent applications as under: -

1. Documents required in case of manufacturers already holding licenses from State Licensing Authority (SLA) before 01.10.2012 for the proposed FDCs shall at least contains: -

   • a) Form CT-21 (duly filled, signed and stamped)

   • b) Fees as specified in sixth schedule of New Drugs and Clinical Trials Rules 2019 through Bharatkosh Name and composition of the FDC

   • c) Product Permission issued by SLA

   • d) Copy of Manufacturing license in Form 25/28

edule of New Drugs and Clinical Trials Rules 2019 through Bharatkosh Name and composition of the FDC

• c) Product Permission issued by SLA

• d) Copy of Manufacturing license in Form 25/28

• e) Phase IV trial protocol / commitment for conducting Active Post Marketing Surveillance study protocol, as the case may be.

2. Documents required in case of new manufacturers for the proposed FDCs shall at least contains: -

   • a) Form CT-21 (duly filled, signed and stamped)

   • b) Fees as specified in sixth schedule of New Drugs and Clinical Rules 2019 through Bharatkosh.

   • c) Name and composition of the FDC

   • d) Product Permission issued by SLA in Form 29

   • e) Copy of Manufacturing license in Form 25/28

   • f) Stability studies data (06 months accelerated) g) Test Specifications of the FDC along with Method of Analysis h) Phase IV trial protocol / commitment for conducting Active Post Marketing Surveillance study protocol, as the case may be.

3. All the manufacturers who are already holding licenses from State Licensing Authorities for such FDCs before 01.10.2012 and did not apply to DCG(I) are required to submit their applications to this Directorate at the earliest but not later than 6 months, failing which their applications will not be considered and their licenses will be considered as without legal validity.

In view of above, all concerned stakeholders are required to follow above procedure for clearance of such cases.

Yours faithfully,

(Dr. Ra i uvanshi)

be considered as without legal validity.

In view of above, all concerned stakeholders are required to follow above procedure for clearance of such cases.

Yours faithfully,

(Dr. Ra i uvanshi)

To:All State/UT Drugs Controllers/All Zonal/Sub Zonal offices of CDSCO.

• Copy to:1. PPS to Secretary/AS(F&D)/JS(R), Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.

  2. Drug Manufacturing Associations/Website of CDSCO.