19 th SEC- (Antimicrobial, antiparasitic& antifungal, antiviral) meeting held on at CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi

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1 19 th SEC- (Antimicrobial, antiparasitic& antifungal, antiviral) meeting held on at CDSCO (HQ), FDA Bhawan, Kotla road, New Delhi Recommendation:- The 19th SEC (Antimicrobial, antiparasitic& antifungal, antiviral) meeting deliberated the proposals on and recommended the following Agenda No File Name & Drug name, Strength Firm Name New Drug Proposals /15-DC Ceftarolinefasamil injection M/s. Astrazeneca /14-DC Cadexomer Iodine Powder/ Ointment M/s. Virchow Biotech Pvt. Ltd. Recommendations The Firm presented the data of Global clinical trial which have 771 subjects of which 200 were from India. Of which only 100 were given Ceftarolin. The firm could not present the subset analysis with respect ot safety and efficacy of Indian subject. The study was conducted at many centres in India. It could not be ascertained how many centres actually participated and how many patients were enrolled in each centres. The Committee recommended that the firm should present the above information along with the details of the approved protocol before the Committee for further review. The firm presented its proposal. After detailed deliberation, the Committee recommended the study subject to the following amendment in the Protocol 1. The claim of the ointment/powder should be appropiate. 2. The application of investigational product on the wound must be done by the Investigator by the competent paramedic, trained for dressing the wound as per the protocol. 3. All subject should be provided with the diary to record any adverse effect. The diary should also have symptoms checklist. 4. In no case, the standard care should be compromised. In case where the wound requires Iodine application, it must not be put on simple saline dressing at any stage of the study. 5. The informed consent must include the information about the need of option of saline and Iodine. 6. The number of subjects mentioned in the protocol should be followed for both powder and ointment separate.

2 /15-dc Sofosbuvir + Ledipasvir tablet Fixed Dose Combination Proposals /2006-dc(Pt- Sigma) Dihydroartemisinin +Piperaquine (DHA+PQP) Euraatesim (160mg PQP/20mg DHA) Medical Devices Proposals M/s MD/2012 -DC M/s Hetero labs M/s Sigma tau India. Biomet Orthopaedics India Pvt. Ltd. Mumbai 7. The informed consent should be corrected. The firm did not turn up for the presentation. The committee noted that the FDC is the need of the country for use in children. The adult formulation is already approved in India. The paediatric use of the FDC is approved in EU, UK, France etc. The PSUR data of 1275 paediatric patients receiving the formulation was presented and there was no safety concern. There was 1 death as per PSUR which was deliberated and it was observed that it was not related to the trial. The committee recommended that the present trial with the lower strength can be considered with following suggestions: 1. A special precautionary step shall be defined for children for extreme low age i.e 6 months to 2 years. 2. Normal BMI in subjects shall be included as per Indian standards. 3. Number of 100 subjects is neither statistically nor biologically valid. However, considering this that the drug is already approved in other countries, a review of data generated on proposed 100 patients may be done by the committee for assessing safety and efficacy and if acceptable, permission will be conducted for marketing. 4. In the extreme low body weight, accurate dosing shall be enclosed. The Company imports Septocoll E manufactured by M/s. Syntacoll GmbH, Saal/Donau, Germany. It holds valid Import Regiatration Certificate & Import Licence (Form -10) vide MD-1121 dated 25/06/2013 valid till 30/04/2016. The product is Equine Collagen containing Gentamicin in two salt forms. The product was approved in 2009 as absorbable haemostat. The SEC (Antimicrobial, Antiparasitic, Antifungal & Antiviral) in it s meeting held on , in reference to a similar product, expressed its concern over the development of the microbial resistance in wound healing. In addition, gentamycin is not effective against gram positive organisms which are commonly found in wounds. The company was asked to provide explanation and data as to why gentamycin in Equine Collagen should be allowed to continue with the changed scenario.

3 Further the company s IFU and medical literatures in record with CDSCO has much expanded indication than approved which are not valid. The company should provide evidence in support of their claims. 6 CT/11/15 Rifampicin +Isoniazide+Pyrizin amide+ethambutal/ Levofloxacin Global Clinical Trial Proposal National Institute Risk versus Benefit to the patients- In light of the for research in fact that the test drugs are old drugs and marketed in T.B India, the safety profile of the test drugs justify the conduct of the trial. Innovation vis a vis existing therapeutic option- The purpose of the study is to evaluate the Pharmacokinetic, Safety and Treatment outcomes of multidrug Treatment including high dose Rifampicin with or without Levofloxacin versus standard treatment for Paediatric Tuberculous Meningitis. Unmet need- The test drug may be an alternative treatment option for Pediatric Tuberculous Meningitis. 7 CT/12/15 Rifampicin +Isoniazide+Pyrizin amide+ethambutal/ Levofloxacin B.J Govt medical college,pune After detailed deliberation the committee recommended the conduct of the study subject to the following conditions: 1. For analysis purposes only definite TBM cases must be included. 2. The study should be conducted with ARM 1 and ARM 3 of the proposed protocol. The committee did not recommend the inclusion of ARM 2 (RhighHZ+L) at this stage. Accordingly the applicants should submit the revised protocol for the further approval by CDSCO. The data generated with the revised protocol ( Arm 1 and Arm 3) will be further reviewed. Risk versus Benefit to the patients- In light of the fact that the test drugs are old drugs and marketed in India, the safety profile of the test drugs justify the conduct of the trial. Innovation vis a vis existing therapeutic option- The purpose of the study is to evaluate the Pharmacokinetic, Safety and Treatment outcomes of multidrug Treatment including high dose Rifampicin with or without Levofloxacin versus standard treatment for Paediatric Tuberculous Meningitis. Unmet need- The test drug may be an alternative treatment option for Pediatric Tuberculous Meningitis. After detailed deliberation the committee recommended the conduct of the study subject to the

4 8 CT/27/15 Artemether lumefantrine + amodiaquine : National Inst. Of malaria research, New Delhi following conditions: 1. For analysis purposes only definite TBM cases must be included. 2. The study should be conducted with ARM 1 and ARM 3 of the proposed protocol. The committee did not recommend the inclusion of ARM 2 (RhighHZ+L) at this stage. Accordingly the applicants should submit the revised protocol for the further approval by CDSCO. The data generated with the revised protocol ( Arm 1 and Arm 3) will be further reviewed. The applicant presented that the proposal is an academic study and is not meant to generate data for Market authorization or new claims of the drugs used in the trial. The applicant presented that the individual drugs are approved for use in the same dosage form, indication, route of administration and do not fall under the definition of New Drug. The committee examined the proposal and opined that complete details have not been presented before the Committee. Further, the intervention is proposed to be used in patients aged 6 months to 65 yrs, drugdrug interaction study and PK-PD interactions which require clarifications. The Committee recommended that the applicant should submit the detailed data/information as mentioned above for further consideration. Dr.Y.K Gupta did not participate in this discussion

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