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1. RECOMMENDATIONS OF THE NDAC (DERMATOLOGY AND ALLERGY) HELD
ON 23.03.2012-
The NDAC (Dermatology and Allergy) deliberated the proposals on 23.03.2012 and recommended the following:- RECOMMENDATIONS
Global Clinical Trials
The firm has earlier conducted similar study in India. Committee recommended for approval of the study subject to the following conditions: The study should be conducted in at least 2 The trial should be conducted only in patients Number of subjects to be enrolled from India Debrase Gel
Dressing
number of subjects to be enrolled globally. modified to include the following clause:-“In case of study related injury or death, M/s GVK Bio will provide complete medical care as well as compensation for the injury or death”. Before formal approval of the study is granted by DCG(I), the firm should submit their revised protocol as above for consideration by DCG(I). The study is to assess the efficacy and safety of Ozenoxacin 1% cream applied twice daily for 5 Ozenoxacin
days versus placebo in the treatment of patients with impetigo. In patients with impetigo, the infection cannot be left untreated by giving placebo for days together. Therefore the committee did not recommend for approval of the study. Committee recommended for approval of the study subject to the following conditions: The study should be termed as Phase I/II Hydrochloride
Upper age limit of the subjects to be enrolled There should be culture sensitivity test every 2. RECOMMENDATIONS OF THE NDAC (DERMATOLOGY AND ALLERGY) HELD ON
18.05.2012 :-
The NDAC (Dermatology and Allergy) deliberated the proposals on 18.05.2012 and recommended the following:- Drug name
Recommendations
Committee recommended that firm should initially conduct Phase II clinical trial with the drug to determine safety and efficacy of the product in wounds of different size on atleast 80 Indian patients with different sizes of wounds at a minimum of 3-4 centres geographically distributed across the country out of which at least 2 centres should be from government hospitals. Accordingly, protocols etc. should be submitted to the Office of DCG(I) for approval. Based on the results of Phase II Clinical trials conduct of further Phase Super-Oxidised
Solution
Biomodified Silk
The product is basically intended for wounds of Protein wound
larger sizes. The Phase II data generated so dressing Film
far is not supportive with respect to the safety Committee therefore, recommended that a Phase II multicentric clinical trial should be conducted in at least 40 patients with wounds of minimum size of 10cm x 10cm at 3-4 centres geographically distributed across the country out of which at least 2 centres should be from government hospitals. Accordingly, protocols etc. should be submitted to the office of DCG(I) for approval. Based on the results of Phase II clinical trials conduct of further Phase III clinical trials may be considered. Mupirocin+Sucralf
Mupirocin is generally used in condition where ate Ointment
there is no requirement of cell regeneration. Therefore, use of both Mupirocin & Sucralfate is not rational. Further, mupirocin is not effective in post surgical secondary infections. Hence, the FDC is not rational. Committee did not recommend for the grant of permission for the proposed FDC. Hyaluronic
This new strength is not approved in USA and Acid+Lidocaine
is approved in EU as a medical device. Also Prefilled syringe
there is risk of sensitivity to lidocaine on its At present there is no need for this new strength. The committee therefore, did not recommend for the grant of permission for this new strength of the FDC. 3. RECOMMENDATIONS OF THE NDAC (DERMATOLOGY AND ALLERGY) HELD ON
12.10.2012:-
The NDAC (Dermatology and Allergy) deliberated the proposals on 12.10.2012 and recommended the following:- Drug name
Recommendations
Flutrimazole Cream 1%
presentation. Committee decided to defer the proposal. Beneficial effect of Hyaluronic acid with 0.9% Dermal Filler over the existing product is not supported by the evidence. Therefore recommended that a comparative clinical trial of Hyaluronic acid with 0.9% Hyaluronic acid with 0.9%
Mannitol Prefilled Syringe
Dermal Filler
marketed by the firm should be conducted on at least 120 subjects at four sites geographically distributed in the country with 50% sites in Govt medical Accordingly protocol etc. should be submitted to DCG(I) for his approval. The clinical data so generated should be placed before the committee for examination. Committee recommended that a clinical trial with the proposed formulation in Adapalene Gel 0.3%w/w
Benzoyl Peroxide +
Microsphere Adapalene
Committee opined that there is no rationality of the combikit Ammonium Lactate lotion &Halobetasol propionate Ammonium Lactate +
Halobetasol
propionate
burden to patients where both the drugs may not be required. Hence the committee did not recommend for the combination. Committee recommended that a 3 arm statisticallypowered Tretinonin + clindamycin VsTretinoninVs clindamycin geographically in the country with at least Tretinoin + Clindamycin
Institution is required to be conducted. Accordingly submitted to the committee for further examination. rationality of combining Sodium Fusidate with Fusidic Acid +
Fluticasone Miconazole
The proposed clinical trial is for generation of data for export purpose. So Committee Clindamycin Phosphate
recommended for giving permission of the study with the condition that at least 50% 1.2% / Benzoyl
Peroxide 5% gel
Government Medical Colleges/ Institutions and other sites should be multispecialty hospitals. conducted in healthy volunteers to assess the safety and tolerability of Selegiline transdermal patch with its multiple dose administration Selegiline
Selegiline is an antidepressant drug, the proposed study in healthy volunteers has serious ethical issue involved. Therefore committee Secukinumab
should make detailed presentation on the core studies in the next meeting so as to take decision on the proposed extension study. Committee recommended that the firm should make detailed presentation on the Secukinumab
core studies in the next meeting so as to take decision on the proposed extension study. 4. RECOMMENDATIONS OF THE NDAC (DERMATOLOGY AND ALLERGY) HELD ON
25.04.2013 -

The NDAC (Dermatology and Allergy) deliberated the proposals on 25.04.2013 and
recommended the following:-
RECOMMENDATIONS
Global Clinical Trials
Parliamentary Standing Committee (PSC) for the Ministry of Health & Family Welfare had presented its 59th report to the Parliament on 08.05.2012 on the functioning of the CDSCO. The report has made various recommendations and observation on various aspects such as approval of New Drugs, Pharmacovigilance, approval of clinical trials etc. The Ministry of Health & Family Welfare has submitted final action taken report on the observation/recommendations contained in the 59th report of the Hon’ble Parliamentary Standing Committee. As per the action taken report, it has been decided by the Ministry that 73 drugs including Fixed Dose Combinations, on approval of which the Hon’ble PSC has made various observations, would be Daptomycin
referred to the NDACs for examination and review Powder for
related to continued marketing of these drugs and concentrate
updating of their product monographs in light of for solution
for infusion
overseas. Out of these 73 drugs, 1 drug is in the 350mg/500mg
category of (Dermatology and Allergy) which is Daptomycin Powder for concentrate for solution for infusion 350mg/500mg per vial The NDAC (Dermatology and Allergy) discussed the issue and noted that Ministry of Health & Family Welfare has already constituted a Committee to formulate policy guidelines and SOPs for a) approval of new drugs, clinical trials, and banning of drugs under the Chairmanship of Dr. Ranjit Roy Chaudhury and b) for approval of the Chairmanship Dr. C.K. Kokate. Therefore, the Committee opined that these drugs related to continued marketing and updating of the product monograph in the light of recent knowledge and regulatory changes overseas could be examined as per policies, guidelines and SOPs being prepared by the Dr. Ranjit Roy Chaudhury Committee and Dr. C.K. Kokate Committee. However, in the meantime the data/information on safety, efficacy of this drug including published data, PMS/PSUR, PSUR data especially on Indian patient required to be prepared in the Form of Dossier. Such data should be prepared from three different sources viz. i) by CDSCO ii) by Pharmacovigilance Programme of India (PvPI) and iii) the firm concerned. The Dossier shall be circulated to all the experts of the NDAC (Dermatology and Allergy) for their further review. If needed manufacturer may be requested to make their Presentation before the NDAC on safety and efficacy of the drug. The NDAC further recommended the following :- CDSCO may collect the following information on the drug The date of manufacturing and marketing of the The mandatory PSUR reports submitted by these Pharmacovigilance data if any from PVPI on the Clause, condition and opinion under which As soon as the above information is available, a meeting may be called. In the meeting, the recommendations of the other 2 committees may be placed which would be discussed. The data presented was an open label trial MEBO Burn
conducted in only one region. Committee opined Ointment
that a Phase III double blind trial on large number of patients should be conducted in India. 50% of the sites should be Govt hospitals and the sites should be geographically distributed across the country. Microbiological culture data before application of the test and reference drug should also be included in the protocol. Accordingly, protocol etc. should be submitted to DCGI for evaluation by the committee. Committee recommended that a Phase III clinical trial should be conducted in India on statistically significant number of subjects for evaluating the Tazarotene
safety and efficacy at sites geographically Microsphere
distributed across the country. 50% of the sites Gel 0.1% w/w
should be Govt. Hospitals/medical colleges. Accordingly, protocol etc. should be submitted to DCGI for evaluation by the committee. Isotretinoin
soft gelatin
The firm did not turn up for presentation, therefore the committee deferred the proposal. Capsules 16
mg
Committee opined that there is no Indian data on the proposed dosage form. Therefore committee recommended for conducting a Phase 3 clinical Minocycline
trial in India with the proposed formulation to prove ER tablet
its safety and efficacy. Accordingly, protocol etc. should be submitted to DCGI for evaluation by the committee. The firm should also submit adverse event data observed with the 100mg formulation. Firm could not produce any data with respect to the PK study of Finasteride. Moreover, there is no published data on the use of Finasteride as topical preparation. The proposed FDC is also not Finasteride +
approved anywhere in the world. Firm could not Minoxidil
justify any rationality for the proposed FDC. Committee opined that the proposed FDC is not rationale, hence not recommended. Committee recommended that a three arm, single Tretinoin
blind, Phase III clinical trial should be conducted in microsphere
India on statistically significant number of subjects for evaluating the safety and efficacy at sites w/w/0.1% w/w
geographically distributed across the country.50% of the sites should be Govt. Hospitals/medical Clindamycin
colleges. Accordingly, protocol etc. should be 1% w/w/1%
The committee recommended that a double-blind, randomized clinical trial should be conducted in Indian patients in a specific indication. Hence, a new detailed protocol should be submitted for the review by the committee. The committee opined that the protocol for the FDC of Gentamycin and Vancomycin and its rationality for the proposed indication requires the opinion of a surgeon. The committee recommended that the company has to submit the Phase IV and PSUR’s data prior Etanercept
Out of 6 experts; 4 experts namely Dr. Amrinderjit Kanwar, Dr. D.M. Thappa, Dr. S.N. Bhattacharya and Dr. C. Adithan strongly recommended the preparation
of epidermal
However 2 of the experts namely Dr. Vijay Kumar and Dr. H.S. Rehan opined that the investigator shall submit pre-clinical and clinical safety and PK data. The committee recommended for approval of the Azathioprine
Secukinumab
examination
Secukinumab
examination
The committee opined that the study with Selegiline patches for 21 days is not justified in Selegiline
healthy volunteers due to ethical issues. The committee rejected the proposal for the clinical examination

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