AGENDA ITEM NO.40.1: TO CONFIRM THE MINUTES OF THE THIRTY NINETH MEETING OF CPCSEA HELD ON

Transcription

1 1 MINUTES OF THE XL MEETING OF COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF EXPERIMENTS ON ANIMALS (CPCSEA) HELD ON AT 11:00 A.M. IN THE MINISTRY OF ENVIRONMENT & FORESTS, PARYAVARAN BHAWAN, CGO COMPLEX, LODHI ROAD, NEW DELHI enclosed. A list of members who attended the meeting and those who were granted leave of absence is AGENDA ITEM NO.40.1: TO CONFIRM THE MINUTES OF THE THIRTY NINETH MEETING OF CPCSEA HELD ON The Committee confirmed the Minutes of the XXXIX Meeting, which was held on AGENDA ITEM NO. 40.2: TO REVIEW THE ACTION TAKEN ON THE MINUTES OF THE XXXIX MEETING AND PENDING ISSUES OF PREVIOUS MEETINGS OF CPCSEA : Review of experiments using animals in case of traditional medicine. The Committee perused the compliance report received from different councils under the Department of AYUSH and noted the status Approval of Animal House facility by CPCSEA (a) Bharat Serum & Vaccines Limited, Thane, Maharashtra. The Committee requested the CPCSEA Inspection team to fix the date for inspection of the Animal House Facility at the earliest Approval of Animal House Facility by CPCSEA - All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi. The committee noted the status.

2 One day Workshop of CPCSEA, Proposed to be held in Goa in the month of March, The Committee was informed that the file is under consideration of IFD. Member Secretary, CPCSEA was pursue the matter Training of CPCSEA nominees is to be organized in different cities / region to apprise them on evaluation of protocols and conduct of Institutional Animal Ethics Committee (IAEC) meetings. The committee noted the status The Member Secretary, CPCSEA proposed to hold an International Conference of CPCSEA in the month of February, 2012 instead of the National Conference. The committee was apprised regarding the proposed International Conference of CPCSEA and was conveyed to the committee that the file is under consideration. The committee noted the status Proposal for harmonization of Indian regulatory guidelines with International regulatory guidelines and introduction of valid alternatives in Indian test guidelines with a view to refine, reduce, and replace the use of animals in regulatory testing in India. Dr. Shiranee Pereira, a member of the Sub-Committee for harmonization of India regulatory guidelines informed the committee that the guidelines are in the final stage of documentation and will be placed before the committee shortly.

3 3 AGENDA ITEM NO : CONSIDERATION OF PROPOSALS RELATED TO ANIMAL EXPERIMENTATION. AGENDA ITEM NO : UPDATE REGARDING PROPOSALS SUBMITTED EARLIER AND DEFERRED/ CONSIDERED BY THE CPCSEA IN VARIOUS MEETINGS / CPCSEA SUB- COMMITTEE. S. No. Name of the institute/name of the Investigator Project Title Decision of the Committee in previous meetings of CPCSEA Decision of XL CPCSEA meeting 1 Bio-Med (P) Ltd, C-96, site No. 1, B.S. Road, Industrial Ara, Ghaziabad Dr. S.P. Garg, Testing the neurovirulence of Varicella virus (Chicken Pox) live Mother Seed in Monkeys. Species/common name : Macacca mulatta / Rhesus Monkey Age / Weight : About 3-5 kg of weight Gender / Sex : Either No. to be used : (Year wise breakups and total figures need to be given) : 10 nos. Number of days each animal will be housed: 5 months Proposed source of animals : Indian Animal Supplier, Lucknow No funding declaration The committee decided to seek clarification from the establishment regarding the duration of the study whether it is for 5 months or 24 months.

4 4 2 Intervet India Pvt Ltd, Briahnagar, Off Pune- Nagar Road, Wagholi , Dist- Pune, India Mr. A. Bhuvaneswari Dose Response Study of Rabies vaccine virus ORA-DPC in Dogs by Parenteral Vaccination. Species/common name : Stray Dogs- Non descriptive Age / Weight : > 6 months old Gender / Sex : Either sex No. to be used : 20 Number of days each animal : NA Animal will be housed : 5 months Proposed source of animals : PCMC/ Stray Form B (Part A) item 3- statement is misleading and may be wrong also There are organized breeder available In case where nonbeagle dogs are used they need to be similar background like breed, age and health failing which failing which authenticity and quality of research may be questioned and such protocol should not considered unless revised After acquiring local dogs, it must be proven adequately, about their uniformity in health & seronegativety and then protocol may be approved Research is claimed to be for regulatory purpose No guideline reference quoted I suggest to conduct MTD/range finding study with 1+1 animal For the main study, 3 animals are recommended The committee decided to ask the establishment to specify the breed of the dog to be used for research. Further, the committee has decided that the clarification may be submitted to the Sub-Committee for pre-scrutiny of research protocol and if found satisfactory, Chairman, CPCSEA can approve the protocol.

5 5 3 Intervet India Pvt Ltd, Briahnagar, Off Pune- Nagar Road, Wagholi , Dist- Pune, India Mr. A. Bhuvaneswari PPR vaccine-seed Virus Safety and Potency Study. Species/common name : Goat kids and labs Age / Weight : > 3 month old Gender / Sex : M/F No. to be used : 80 Goat Kids and 60 Labs Number of days each animal will be housed : 5 months Proposed source of animals : Selected Contract Suppliers IBC minutes not attached as stated in Form B-item 15 Animal per group may restricted to 3/4 per group instead of 5 Additional 5 goats and 5 sheep are not rationalized in 3 rd subset, hence not to be approved Total number may be restricted to 63 & 43 respectively minutes of meeting, IAEC not attached The Committee decided to seek clarification from the establishment, regarding the number of batches to be manufacture in a year. Further, the committee decided to ask the establishment to use nonpregnant, kid and lambs and the numbers of animals as under:- For safety, Sheep - 2 numbers per group. Kid 2 numbers per group. For potency Sheep per batch Kid per batch

6 6 4 Advinus Therapeutics Private Limited, Plot Nos. 21 & 22, Phase II Peenya Industrial Area, Bangalore , Karnataka Dr. Vinay H.K. 5 Advinus Therapeutics Private Limited, Plot Nos. 21 & 22, Phase II Peenya Industrial Area, Bangalore , Karnataka Dr. S.M. Sulaiman Pharmacokinetics of test compounds in Beagle Dog. Test compounds may include compounds for the treatment of cardiovascular disorders like hypertension, respiratory disorders like asthma, endocrine disorders like diabetes mellitus, infectious disorders, gastrointestinal disorders etc. Project Cods : PK-Dog/10. Species/common name : Beagle dog Age / Weight : About 1 year to 5 years Gender / Sex : Male and Female No. to be used : The PK requirement is 75 studies, each in about 4 dogs or as per the study plan. Each study may take up to 1.5 months for completion (including dosing, washout and recovery) ; Four dogs can support 8 studies in a year [12/1.5]. Therefore 75 studies each using 4 dogs would require about 40 dogs [75 x 4/8]. (Year-wise breakups and total figures needed to be given) Evaluation of test item for Acute Oral Toxicity in Livestock (Goats) Project Cods : AT-LIVE-1/10. Species/common name : Goats Age / Weight : 6-10 months or as per the requirement Gender / Sex : Male and Female in equal number No. to be used : As per the regulatory / guideline requirements, Gaitonde Sub Committee guideline, Govt. of India. The number of animals required for each study is Pre-study : 1-2 M + (MTDapproach) Main study : limit test : 1-2 M+ 1-2F Three doses : 3-6M +3-6F (Year-wise breakups and total figures needed to be given) Number of days each animal will be housed : Duration 4-5 weeks. IAEC meeting held on 12 Aug 10, checklist with IAEC recommendation statement signed on 3 Aug 10 Check list- IAEC only recommends not approves large animal application No test item details furnished. 75 studies are propsed. Details are not provided IAEC meeting held on 12 Aug 10, checklist with IAEC recommendation statement signed on 3 Aug 10 Check list- IAEC only recommends not approves large animal application No test item details furnished. 75 studies are propsed. Details are not provided Total number of animal requested are not clear 8-16, is it 8 to 16 or 8/16 Further, the committee has decided to seek clarification from the establishment, whether, the used animals will be re-used again and if reused then approval should be taken from CPCSEA before using these animals.

7 7 6 Advinus Therapeutics Private Limited, Plot Nos. 21 & 22, Phase II Peenya Industrial Area, Bangalore , Karnataka Dr.. Vinay H.K. 7 Sree Chitra Tirunal Institute for Medical Sciences and Technology, Bio Medicla Technology Wing, Poojappura Thiruvanant hapuram , Kerala/Dr. P.R. Umasankar Bioavailability and Bioequivalence (BA/BE) studies of test compounds in Beagle dog. Test compounds may include compounds for the treatment of cardiovascular disorders like hypertension, respiratory disorders like asthma, neurologic disorders like parkinson s disease, endocrine disorders like diabetes mellitus, infectious disorders, gastrointestinal disorders etc. Project Cods : BA-BE-Dog/10. Species/common name : Beagle dog Age / Weight : About 1 year to 12 years Gender / Sex : Male and Female No. to be used : The requirement is for 50 animals. -Number of planned studies : 8 - Number of animals in each study : up to 48 (for highly variable drugs). -Each study may take up to 1.5 months for completion (including acclimatization, dosing and washout period). This enables up to 8 studies a year [12/1.5]. (Year-wise breakups and total figures needed to be given) Studies on induced cardiac regeneration through injectable scaffolds in a pig MI model. Species/common name : Swine, Ankamali Age / Weight : Adult 30 to 60 kg. Gender / Sex : Either sex No. to be used : (Year wise breakups and total figures need to be given) : 49 numbers to be used in one year. Number of days each animal will be housed: upto 8 months Proposed source of animals : DIMT, SCTIMST IAEC meeting held on 12 Aug 10, checklist with IAEC recommendation statement signed on 3 Aug 10 Check list- IAEC only recommends not approves large animal application No test item details furnished. 75 studies are propsed. Details are not provided Protocol is in order. However, PI is seeking blanket permission with out any details on the test item. No funding proof declaration Animal numbers may be restricted to 3 instead of 5 per set/group i. e total 33 instead of 49 IAEC minutes not attached, subject to use of only 3 numbers per group/set of animals.

8 8 8 Sree Chitra Tirunal Institute for Medical Sciences and Technology, Bio Medicla Technology Wing, Poojappura Thiruvanant hapuram , Kerala Dr. Annie John, Tissue-engineered ceramic for promoting osteointegration in osteoporotic animal models with relevance to clinical problem in women. Species/common name : Ovis Aries / Domestic sheep. Age / Weight : adults > 4 years kg. Gender / Sex : Female No. to be used : (Year wise breakups and total figures need to be given) : A total of 12 animals are required during the study period. Number of days each animal will be housed: Including Quarantine and study period -1 year Proposed source of animals : Large Animal Facility No funding declaration IAEC minutes not attached 9 Sree Chitra Tirunal Institute for Medical Sciences and Technology, Bio Medicla Technology Wing, Poojappura Thiruvanant hapuram , Kerala/ Dr. P.D. Nair Reversal of diabetes in a diabetic porcine animal model by xenotransplantation of encapsulated Islet like clusters derived from human mesenchymal stem cells in PU-PVP IPN macrocapsules. Species/common name: Swine, Ankamali. Age / Weight : adults, 30 to 60 kg, Gender / Sex : Either sex No. to be used : (Year wise breakups and total figures need to be given) : 16 numbers to be used in one year Number of days each animal will be housed: up to 12 months Proposed source of animals DIMT, SCTIMST. No funding declaration IAEC minutes not available Animal numbers may be restricted to 3 instead of 5 per set/group i. e total 12 instead of 16, subject to use of 3 numbers of animals per group i.e., total only 12 number of animals.

9 9 10 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II,Peenya Industrial Area,Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-11 in Beagle dogs Project Code : DRF-5/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Dogs Sex G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M 1. In all the protocols the requirement of animals are given in range. 2. PI may be advised to justify as why exact number cannot be proposed. 3.Therapeutic indication of the coded compound may be given where applicable

10 10 11 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-12 in Beagle dogs Project Code : DRF-6/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M

11 11 12 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-12 in Beagle dogs Project Code : DRF-7/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M

12 12 13 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-14 in Beagle dogs Project Code : DRF-8/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M

13 13 14 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-15 in Beagle dogs Project Code : DRF-9/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is : -do- Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M

14 14 15 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item for Dose Range finding Study with PS-16 in Beagle dogs Project Code : DRF-10/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 4-8 M F When single gender is used : 8 M or 8 F In the case of combined repeat dose with escalation study, 2 (1 M+1 F) will be used in Phase I and 4-8 animals in equal sexes will be used for Phase II repeat dose study. Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M F G2 xx 1-2 M G3 xx 1-2 M G4 xx 1-2 M

15 15 16 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-11 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-5/2011 Age : 4-9 months or as per the requirement Gender: Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is 1. In all the protocols the requirement of animals are given in range. 2. PI may be advised to justify as why exact number cannot be proposed. 3. In case of MTD studies animals may be reduced to 2 instead of Therapeutic indication of the coded compound may be given where applicable Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

16 16 17 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-12 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-6/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

17 17 18 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-13 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-7/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

18 18 19 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-14 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-8/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

19 19 20 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-15 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-9/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

20 20 21 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item DE-16 for Maximum Tolerated Dose assessment in Beagle dogs Project Code : MTD-10/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers or as per Study requirement Number to be used : (Year-wise breakups and total figures needed to be given) -do- As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : 1-2 M + When single gender is used : 4 M or 4 F Typical DRF study Design: Group Dose No. of Sex Dogs G1 xx 1-2 M

21 21 22 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Evaluation of test item SCT-13 for Subchronic toxicity in Beagle dogs Project Code : SCD-5/2011 Age: 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is 1. In all the protocols the requirement of animals are given in range. 2. PI may be advised to justify as why exact number cannot be proposed. 3.Therapeutic indication of the coded compound may be given where applicable, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Group Dose No. of Se Dogs x G1/GIR Xx 5-8 M 5-8 F G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F G4/G4R Xx 5-8 M 5-8 F

22 22 23 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao 1 Evaluation of test item SCT-14 for Subchronic toxicity in Beagle dogs Project Code : SCD-6/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is -do-, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Group Dose No. of Sex Dogs G1/GIR Xx 5-8 M 5-8 F G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F G4/G4R Xx 5-8 M 5-8 F

23 23 24 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Received on Evaluation of test item SCT-15 for Subchronic toxicity in Beagle dogs Project Code : SCD-7/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is -do-, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Group Dose No. of Sex Dogs G1/GI Xx 5-8 M R 5-8 F G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F G4/G 4R Xx 5-8 M 5-8 F

24 24 25 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Received on Evaluation of test item SCT-16 for Subchronic toxicity in Beagle dogs Project Code : SCD-8/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Group Dose No. of Sex Dogs G1/GI Xx 5-8 M R 5-8 F G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F G4/G 4R Xx 5-8 M 5-8 F - do -, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine

25 25 26 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Received on Evaluation of test item SCT-17 for Subchronic toxicity in Beagle dogs Project Code : SCD-9/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Group Dose No. of Sex Dogs G1/GIR Xx 5-8 M 5-8 F G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F Xx 5-8 M G4/G4R 5-8 F - do -, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine

26 26 27 Advinus Therapeutics Limited Plot Nos. 21 & 22, Phase II Peenya Industrial Area Bangalore , Karnataka / Dr. K. Venugopala Rao Received on Evaluation of test item SCT-18 for Subchronic toxicity in Beagle dogs Project Code : SCD-10/2011 Age : 4-9 months or as per the requirement Gender : Male and Females in equal numbers Number to be used : (Year-wise breakups and total figures needed to be given) As per regulatory / guidelines requirements (OECD, OPPTS, US, FDA, ICH, EMEA, Schedule Y, Drugs and Cosmetics Act, (2 nd Amendment) 2005, Govt. of India). The number of animals required for each study is Main Study : M F When single gender is used : M or F only. In the case of combined repeat dose with pre-study, 2-8 of equal sex may be used for the purpose of pre-study. At any circumstances, the total no. usage shall not exceed 48 animals. Grou Dose No. of Dogs Sex p G1/G IR Xx 5-8 M 5-8 F - do -, subject to use of only 5 numbers of animal. Further, the establishment has been asked to specify the product / define the molecule, whether agrochemical / drug / vaccine. 28 Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat, India Dr. Hemanshu J. Kavani Received on G2 Xx 3-4 M 3-4 F G3 Xx 3-4 M 3-4 F G4/G Xx 5-8 M 4R 5-8 F Single dose oral Pharmacokinetics Study in Beagle Dogs. (Canis familiaris) Age / Weight : months Gender / Sex : Male and Female No. to be used : Total 4 (2M + 2F) (Total figures needed to be given) Number of days each animal : 15 days Proposed source of animals: Marshall Bioresources, China 1.Check list- Incomplete information about type, number, age, sex of animals 2.Justification for sampling time points is necessary to declare no undue physiological stress on animals 3.Test item/code may be stated. 4.Name of Test item is not stated

27 27 29 Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat, India Dr. Hemanshu J. Kavani Received on Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat, India Dr. Hemanshu J. Kavani Received on Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat, India Dr. Hemanshu J. Kavani Received on Cross over Pharmacokinetics Study in Beagle dogs. (Canis familiaris) Age / Weight : > 4 months Gender / Sex : Male No. to be used : Total 4 male (Total figures needed to be given) Number of days each animal : 21 days Proposed source of animals : Marshall Bioresources, China Pharmacokinetic study in beagle dog. (Canis familiaris) Age / Weight : >4 months Gender / Sex : Male No. to be used : (Year-wise breakups and Total figures needed to be given): Total : 4 Number of days each animal : 30 days Proposed source of animals : Marshall Bioresources, China Repeated dose 30 days toxicity study in beagle dogs (including dose range finding) (Canis familiaris) Age / Weight : 4-6 months Gender / Sex : Male and Female No. to be used : (Year-wise breakups and Total figures needed to be given): For range finding (MTD & 14 days) : 9 M + 9 F = 18 For Main study (30 days with recovery) : 20 M + 20 F = 40 Total : 2 M +29 F Number of days each animal : 7 days / week for 4 months Proposed source of animals : Marshall Bioresources, China 1.Check list- Incomplete information about type, number, age, sex of animals 2.Justification for sampling time points is necessary to declare no undue physiological stress on animals 3.Test item/code may be stated. 4.Name of Test item is not stated 1.Check list- Incomplete information about type, number, age, sex of animals 2.Justification for sampling time points is necessary to declare no undue physiological stress on animals 3. Test item/code may be stated. 4.Name of Test item is not stated 1.Check list- Incomplete information about type, number, age, sex of animals 2. Sacrificed of MTD study animals is not justified, as per protocol annexure, no Gross or Histopathology required on these animals th MOM proposal no. 895 & 896 (dog), study titles same

28 28 32 Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat, India Dr. Hemanshu J. Kavani Received on Single treatment, parallel group comparative bioavailability study of Olanzapine pamoate in Dogs. (Canis familiaris) Age / Weight : >4 months Gender / Sex : Male No. to be used : (Year-wise breakups and Total figures needed to be given): Total : 6 male Number of days each animal : 30 days Proposed source of animals : Marshall Bioresources, China 1. Check list- Incomplete information about type, number, age, sex of animals. 2.Justification for sampling time points is necessary to declare no undue physiological Stress on animals. 3. Test item/code may be stated. 4.Name of Test item is not stated 33 BAIF Development Research Foundation, Central Research Station (CRS), Uruli Kanchan, Tal. Haveli, Dist, Pune , Maharashtra / Dr. S.B. Gokhale and Dr. S.S. Majumdar Received on Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat / Dr. Hemanshu J. Kavani Received on A feasibility study to generate transgenic livestock to express human proteins of therapeutic value in the milk. a) Species / Common Name Buffalow, Cow and Goat. b) Age/ Weight/ Size Pubertal age. c) Gender Female. d) Number to be used Just five animals of each species for preliminary study, over period of two years. e) Number of days each animal will be housed Will be kept in farm under natural condition during study period. f) Proposed sources of animals From farm near Pune. Three treatment, 6 period, Crossover comparative bioavailability study of Aprepitant in Male Beagle Dogs. a) Species / Common Name Beagle Dog (Canis Familaris). b) Age/ Weight/ Size - > 8 months c) Gender Male d) Number to be used Total 5 male e) Number of days each animal will be housed 40 days f) Proposed sources of animals Marshall Bioresources, China. The Committee desired a presentation from the establishment. Further, the Chairman, CPCSEA is of the view that comments may be sought from Review Committee on Genetic Manipulation (RCGM) and the research protocol should be forwarded to Dr. Ranjini Warrier Additional Director & Member Secretary (GEAC), Ministry of Environment & Forests, for comments. The committee desired a presentation., provided the establishment must obtain all other mandatory/relev ant regulatory requirements. The committee decided to ask the establishment to validate the analytical method before further consideration / approval of the research protocol CPCSESA. by

29 29 35 Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat / Dr. Hemanshu J. Kavani Received on Jai Research Foundation (JRF), Valvada , Dist. Valsad, Gujarat / Dr. Hemanshu J. Kavani Received on National Research Centre on Equines, Sirsa Road, Hisar , (Haryana) Dr. Suresh Chandra Yadav Received on : Ocular pharmacokinetic and tolerance study in beagle dog. a) Species / Common Name Beagle Dog (Canis Familaris). b) Age/ Weight/ Size - > 4 months c) Gender Male or Female d) Number to be used Total 20 male or 20 Female (Preliminary 1 and for main 19) e) Number of days each animal will be housed 08 days f) Proposed sources of animals Marshall Bioresources, China. Repeated dose 30 days toxicity Study of NRC-AN-024 in Beagle Dogs (Including MTD / DRF) a) Species / Common Name Beagle Dog (Canis Familaris). b) Age/ Weight/ Size months age c) Gender Male or Female d) Number to be used For Range finding (MTD / DRF)- 2M+2F=04 For Main study (30 days with recovery) 16 M +16F= 32 e) Number of days each animal will be housed 7 days / week for 6 months f) Proposed sources of animals Marshall Bioresources, China. Cysteine prroteinase, a defined antigen of Trypanosoma evansi for control of Trypanosomosis. Species/common name : Horse ponies Age / Weight : years/ 200kg/ Young Gender : Female No. to be used : 16 -do- It has been informed to the committee that the establishment has cancelled the protocol and hence, the committee decided to Reject the research protocol. -do- No person / Representative came for presentation of the research protocol. The committee decided to take up the research protocol and ask the establishment to depute a person for presentation of the research protocol in the next meeting of CPCSEA. Decision of XXXIXth CPCSEA Meeting, subject to use of only 12 number of animals for a period of one year.

30 30 S. No. 1 AGENDA ITEM NO : NEW PROPOSALS FOR CONSIDERATION OF CPCSEA: Company Name Proposal/Proposal Remarks of the Sub- Decision of XL Committee CPCSEA meeting Aurigene Discovery Technologies Limited (ADTL), Bollaram Road, Miyapur, Hyderabad , Andhra Pradesh / Dr. Sunil Kumar K.B. Received on 2 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. Karmati Srinivas Received on Ascending dose Maximum tolerated Dose Study in Beagle dogs a) Species : Dog (Beagle) b) Age /weight/size : years/12-15 kg, large c) Gender : Male / Female d) Number to be used : (Year-wise breakups and total figures need to be given) Total number of dogs required for the proposed study is 8 (4 males and females each) e) Number of days each animal will be housed : 2 males and 2 females for 14 days and remaining 2 males and females for 28 days f) Proposed source of animals : In-house bred animals or imported from outside source Evaluation of potency and safety for Enterotoxaemia and Tetanus combined Vaccine, Inactivated Animals required : Enterotoxaemia component : I. Safety : a) Species : Sheep b) Age/Weight/Size : 18 Kg c) Gender : Male/Female Details of reference drug and the purpose for its inclusion may be provided. Intended clinical use of the coded drug may be stated. Test guidelines copy to be provided. Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Animal usage /requirement for sheep studies is given per batch, but numbers of batches to be evaluated are not mentioned. Investigator declaration, certificate not dated Investigator, chair person- member secretary all same. Some other competent Scientist may perform the expt Sheep must be The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman,

31 31 rehabilitated after experimentation - to include a statement to this effect in the proposal. Clarification has been submitted. CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. 3 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Preparation of chaltenge virus for Bovine herpes Virus 1. Animals required : a) Species : Cattle b) Age/Weight/Size : 3-6 months old c) Gender : Male e) Gender : Male d) Number to be used : 15 (4 animals per virus passage and the passaging will be done thrice, Additional 3 animals will be used for contract exposure study during third passage) e) No of days each animal will be housed : 1 month Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Justification for number of animals not provided. 4 animals per virus passage requested. To justify with experience of the laboratory or from reference. Clarification has been submitted. The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. 4 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Evaluation of safety of Brucella abortus glycolconjugate vaccine candidate in cattle calves Animals required : a) Species : Cattle b) Age/Weight/Size : 6-7 Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Justification for number of cattle requested - 30 The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while

32 32 months old c) Gender : Male d) Number to be used : (Year-wise breakups and total figures need to be given) 60 Nos. (30 cattle for glycolconjugate (GC) vaccine derived from S19 & 30 for GC vaccine from M22P50 e) No of days each animal will be housed : 45 days f) Proposed source of animals : Holding farm cattle per strain is not justified. Since end points are only clinical observation why not use less number of animals (10-12) to derive statistically valid data. Clarification has been submitted. preparing Protocols. the Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. 5 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Evaluation of BCG as vaccine candidate in cattle Animals required : a) Species : Cattle calves b) Age/Weight/Size : 6-12 months old c) Gender : Male d) Number to be used : (Year-wise breakups and total figures need to be given) 50 Nos. (5 groups, 10 animals/group) e) No of days each animal will be housed : 120 days f) Proposed source of animals : Holding farm Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Animal usage/ requirement is huge (50). Clear study design / outline is not available to judge requirement. Why not the study can be conducted on sheep instead of cattle. Justification for 10 animals per group to be provided. Clarification has been submitted. The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the

33 33 Protocols to the committee. 6 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Determination of Immunogenicity of different recombinant PPD (ESAT6/MPB83/MPB70/CFP 10) in cattle Animals required : a) Species : Cattle calves b) Age/Weight/Size : 6-12 months old c) Gender : Male d) Number to be used : (Year-wise breakups and total figures need to be given) 50 Nos. (5 groups, 10 animals/group) e) No of days each animal will be housed : 120 days f) Proposed source of animals : Holding farm Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Animal usage/ requirement is huge (50). Clear study design / outline is not available to judge requirement. Why not the study can be conducted on sheep instead of cattlejustification for 10 animals per group tobe provided. Details of the study including parameters of immunogenicity must be provided. IBSC approval letter attached but the meeting was conducted on 29 th Sept. but proposal was signed on 8 th Sept.Animals must be rehabilitated but not sold to prospective buyers. Study can be combined with the previous one- PI may consider this option The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. Clarification has been submitted. 7 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Evaluation of Novel adjuvant systems for Rabies Vaccine in cattle Animals required : a) Species : Cattle b) Age/Weight/Size : 6-8 months c) Wight : Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached As per check list- IBSC approval obtained but no enclosure available The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the

34 Kgs d) Gender : Male e) Number to be used : 30x One test (Year-wise breakups and total figures need to be given) Vaccination on 0 th day, 7 th day and 21 st day S.No. Group Num ber requi red 01 Regular 5 Formulati on 02 Adjuvant 5 Formulati on 1 03 Adjuvant 5 Formulati on 2 04 Adjuvant 5 formulatio n 3 05 Control 5 06 Un- Vaccinate d 5 (Form B-Item 15 declares contradictory statement to checklist). Please correct. The product may not require IBSC approval at all. No. of animals to be reduced to 4 instead of 5 per group (total approval 24 instead of 30). Protocol / reference / previous work done by the institute may be provided in support of number of animals. Rehabilitation of the animal must be done by the institution. Animals cannot be returned to the dairy farmers. Whether safety of such adjuvant was established in lower species of animals, if so, please provide results/data. Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. Bleeding on 0 th day, 7 th day, 21 st day, 28 th day, 35 th day and 90 th day f) No. of days each animal will be housed : 90 days 8 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Determination of safety and immunogenicity of TSOL18 in swine Animals required : a) Species : Pigs b) Age/Weight/Size : 6-8 months/60 Kg c) Gender : Male/Female Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Since already information available on the efficacy of this recombinant in pigs, why this study is The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols.

35 35 d) Number to be used : 30 Nos. (Year-wise breakups and total figures need to be given) Cattle : 60 nos (8 animals per potency test x 6 potency tests with 2 controls per test) Buffalo : 60 nos ( 8 animals per potency text x 6 potency tests with 2 controls per test) e) No of days each animal will be housed : 120 days f) Proposed source of animals : Holding farm planned. PI may explain the purpose of repetition and also justification of number of animals. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee. 9 Indian Immunological Ltd., Gachibowli, Hyderabad , Andhra Pradesh /Dr. V.A. Srinivasan Received on Development of polyelonal antibodies against measles live attenuated virus in Sheep Animals required : a) Species : Sheep b) Age/Weight/Size : 6-7 months c) Gender : Male d) Number to be used (Yearwise breakups and total figures need to be given) : 4 nos. e) No. of days each animal wii be housed : 365 days f) Proposed source of animals : Holding farm Date of AH inspection shown differently in different proposal from this Institute. IAEC minutes not attached Animal usage /requirement for sheep studies is given per batch, but numbers of batches to be evaluated are not mentioned. Investigator declaration, certificate not dated Investigator, chair person- member secretary all same. Some other competent Scientist may perform the experiment. Sheep must be rehabilitated after experimentation - to include a statement to this effect in the proposal. Clarification has been submitted. (RP-18) The committee decided to Reject the protocols due to lack of proper diligence and casual/reckless approach while preparing the Protocols. Further, the Chairman CPCSEA has asked to send a D.O letter from the Joint Secretary (MoEF) & Vice Chairman, CPCSEA to the Director regarding the casual approach of the concerned persons while presenting the Protocols to the committee.