ICMR & Y.pptx experimental pharmacology pharmacy

pharmacology

1. SHEDULE Y AND ICMR

2. SHEDULE Y 2

3. RULES UNDER SHEDULE Y RULES PERMISSION TO 122 A IMPORT NEW DRUG 122 B MANUFACTURE OF NEW DRUGS 122 D IMPORT OR MANUFACTURE FIXED DOSE COMBINATIONS 122 DA CONDUCT CLINICAL TRIALS FOR NEW DRUGS/IND 122 DAA DEFINITION OF CLINICAL TRIAL 122 DAB COMPENSATION IN CASE OF INJURY OR DEATH DURING CT 122 E DEFINITION OF NEW DRUG 122 DB SUSPENSION/CANCELLATION OF APPROVAL 3

4. APPENDICES OF SCHEDULE Y APPENDIX I Data to be submitted along with the application to conduct clinical trials/import/manufacture of new drugs for marketing in the country. IA Data required to be submitted by an applicant for grant of permission to import to import&/or manufacture a new drug already approved in the country II Structure ,contents & format for clinical study reports III Animal toxicology(non-clinical toxicology studies) V Informed consent VI Fixed dose combinations VII Undertaking by investigators VIII Ethics committee IX Stability testing of new drugs X Contents of proposed protocol for conducting CTs XI Data elements for reporting serious adverse effects occurring in CT 4

5. APPENDIX I 5

6. APPENDIX I A 6

7. APPENDIX II 7

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9. APPENDIX III-ANIMAL TOXICOLOGY 9

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11. 11 TERATOGENICITY STUDIES:

12. Recommended if the drug is to be given to pregnant or nursing mothers for long periods or where are indications of possible adverse effects on fetal development. One rodent species(preferably rat) At least 4 groups(including control),each consisting of 15 animals. The drug should be administered throughout the last trimester of pregnancy and continued throughout lactation Animals should then be sacrificed and examined Observation parameters-(dams)body weight,food intake,general signs of intoxication,progress of gestation/ pups,the clinical signs,sex -wise distribution in dose groups,body weight,growth parameters,histopathology 12 PERINATAL STUDIES

13. LOCAL TOXICITY: Drug applied on appropriate site: guinea pig or rabbits. Observed for hypersensitivity/allergenicity CARCINOGENECITY :if drug metabolite is having carcinogenic potential. 2 species-not having incidence of tumor. A control group 3 doses-highest dose produce sub-lethal effect&toxicity Lowest dose-comparable to for human dose 13

14. APPENDIX VI-FIXED DOSE COMBINATIONS FDC s products containing one or more active ingredients used for a particular indication. First group :one or more of the active ingredients is a new drug. Data submitted for marketing approval will be similar that for any new drug(including clinical trials) Second group :active ingrdients are already approved/marketed individually and are combined for the first time Reports of clinical trials carried out in other countries with the FDC 14

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16. Third group: those which are already marketed,but in which it is proposed either *to change the ratio of active ingredients or *to make a new therapeutic claim. Data to be submitted for obtaining marketing permission: Appropriate rationale including published reports if any. Fourth group:those whose Individual active ingredients (or drugs from the same class)have been widely used in a particular indication(S)for years Their concomitant use is often necessary No claim is proposed other than convenience. Data for marketing permission The proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a PD or PK nature. No additional animal or human data are generally required. 16

17. APPENDIX VII –UNDERTAKING BY INVESTIGATOR 17

18. APPENDIX IX-STABILITY TESTING OF NEW DRUG Evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors To establish shelf life for the formulation/recommended storage Stress testing of the drug substance on single batch to identify degradation products TWO TYPES: Long term testing :should cover a minimum of 12 months’duration on atleast three primary batches of the drug substance or the formulation at the time of submission Accelerated testing :should cover a minimum of 6 months duration at the time of submission 18

19. APPENDIX X-PROPOSED PROTOCOL 19

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21. 9)Study assessment 10)Study conduct 11)Discontinued subjects 12)Study treatment(dosing schedule,drug supplies,administration,dose modification,possible druginteractions,concomitant therapy,blinding/unblinding procedures) 13)Adverse events….etc 21

22. APPENDIX XI-DATA FOR REPORTING SAE 22

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26. AMMENDED SCHEDULE Y Regulations and guidelines for permission for development (preclinical and/ or clinical), import and manufacture of new drugs for marketing in India (20 th June 2005) to frame guidelines for the current scenario of clinical research. CDSCO and DTAB formulated GCP under schedule Y 2005. Schedule Y 1988 relevant to predominantly generic industry. Schedule Y 2005 has outlined extensive study criteria in line with the globally accepted formats such as ICH and US FDA guidelines. 26

27. REVISED OLD 1.Applicaton for permission Nature of trials 2.Clinical trail Clinical trails Approval for clinical trail Responsibilities of sponsor Responsibilities of investigator Informed consent-new Responsibilities of ECs-new Human pharmacology (phase-1) Therapeutic exploratory trails(phase-2) Therapeutic confirmatory trails(phase-3) Post marketing trails(phase4)-new Permission for trails Responsibilities of sponsor/investigators Human clinical pharmacology(phase-1) exploratory trails(phase-2) Confirmatory trails(phase-3) 3.Studies in special population Geriatrics Pediatrics Pregnant or nursing women Special studies 4.Post marketing surveillance Post marketing surveillance study 27 SHEDULE Y 2005

28. REVISED OLD Data to be submitted along with the application to conduct clinical trails/import manufacture of new drugs for marketing in the country Data required to be submitted with application to for permission to market a new drug Information on active ingredients Specification of active and inactive ingredients Physicochemical data Physicochemical proportion Analytical data-new Monograph specification Tests for identification of the active ingredients and method of its assay Validation-new Data on formulation Physicochemical data, validation Safety pharmacology-new Male fertility studies-new allerginicity/hypersensitivity-new Sample and testing protocols Sample with testing protocol 28

29. INDIAN COUNCIL OF MEDICAL RESEARCH ( ICMR )

30. ICMR, New Delhi, is the one of the oldest medical research body in the world and apex body in India. It is the premier national agency for – planning Formulation Co-ordination Implementation Conduct or promotion of biomedical research in India In 1911, government of India set up the ‘Indian Research Fund Association’(IFRA) with specific objective of sponsoring and coordinating medical research in the country 30

31. After independence, several changes were made in organization and the activities of IFRA It was re designated the ‘Indian Council of Medical Research’(ICMR) in 1949,with expanded scope of functions and responsibility The ICMR is funded by the government of india through the ministry of health and family welfare The council not only plans and promote medical research and emerging health problems of the country but also is expected to build strong national group of professional persons in organization of skilled biomedical scientists. Rapid advances in science and technology have brought in new technologies to understand the disease process and find strategies for prevention and cure . 31

32. The policies of ICMR coincides with national health policies such as: Control and management of communicable diseases Fertility control Maternal and child death Control of nutritional disorders Developing alternative strategies for health care delivery Safety limits of environmental and occupational health problems Non-communicable diseases including cancer, cardiovascular, neurological, ophthalmic and hematological disorders 32

33. OBJECTIVE ICMR provides financial assistance to promote biomedical and health research. Proposals in fundamental research; development and evaluation of a tool, clinical and operational research are considered for ICMR support 33

34. GOVERNING BODIES The supreme authority of ICMR, is headed by the ministry of health, government of india The governing body which is the chief executive and decision making authority of ICMR is headed by the Director –general Union health minister Scientific advisory Expert groups Task forces Steering committees etc. Which evaluate and monitor different research activities of the council 34

35. ORGANIZATION STRUCTURE 35 Union minister of health is the ex-officio president of the ICMR society Health secretary, department of health research and education, ministry of health, govt. of india Director-general, ICMR- the principal executive officer of the council Health scientists recruitment board Deputy directors-general Additional secretary ICMR) Additional secretary and financial advisor Assistant directors-general National director, national health innovation project Directorate of information and publication of health

36. ACTIVITIES The ICMR was constituted as an autonomous organization, with the union health minister as president of its governing body. The council promotes biomedical research in the country through intramural research (through institutes totally funded by ICMR) and extramural research (at college or university) 36

37. INTRAMURAL RESEARCH It is carried out currently through the councils 30 research institutes/centers These includes; 19 mission- oriented national institutes: National jalma institute for leprosy and other mycobacterial diseases(NCJILOMD), Agra National institute of occupational health(NIOH),Ahmadabad Tuberculosis research Centre(TRC), Chennai National institute for malaria research (NIMR),Delhi National institute for research in tuberculosis(NIRT),Chennai National institute of pathology(NIP),Delhi National institute of medical statistics(NIMS),Delhi 37

38. National institute for research in environmental health)NIREH),Bhopal National Centre for disease informatics and research, Bangalore National institute for research in reproductive health(NIRRH),Mumbai National institute for immunohematology(NIIH),Mumbai Enterovirus research centre , (ERC),Mumbai Institute of cytology and preventive onchology (ICPO),Noida Rajendra memorial research institute of medical sciences(RMRIMS),Patna Vector control research centre (VCRC),Pondicherry National institute of virology(NIV), pune National AIDS research institute(NARI), pune 38

39. 6 regional medical research centres : Regional medical research Centre , Bhubaneswar Regional medical research Centre, port blair Regional medical research Centre, Jabalpur Desert medicine research Centre, jodhpur Regional medical research Centre, Belgaum 5unit/ centres : Food & drug toxicology centre , Hyderabad National centre of laboratory sciences, Hyderabad ICMR virus centre , Mumbai Genetic research centre ,Mumbai Microbial containment complex, pune 39

40. EXTRAMURAL RESEARCH It is promoted by ICMR through setting up Centres for advanced research in selected departments of medical colleges, universities and other non-ICMR research institutes Task force studies with goal-oriented approach with clearly defined targets Open-ended research in non-ICMR research institutes, medical colleges ,universities etc. located in different parts of the country 40

41. FELLOWSHIP AND SCHEMES The ICMR encourage human resources development in biomedical research through various schemes such as Research fellowships i.e junior and senior fellowships and research associate ships Short-term visiting fellowships which allow scientists to learn advanced research techniques from other well- established research institutes in india Short-term research studentships for undergraduate medical students to encourage them to familiar themselves with research methodologies and techniques Various training programmes and programme and work ships conducted by ICMR institutes and headquarters 41

42. National health schemes: -national malaria eradication programme -national filaria control programme -national leprosy control programme - diarrhoeal disease control programme -national AIDS control programme -national cancer control programme -universal immunization programme 42

43. GRANT SCHEMES studentship- short term studentship Fellowships/associateships- research fellowships/associateships -Junior research fellowships The scheme is aim at promoting good quality research in medical colleges through students persing post graduation courses as well as improve visibility & assessibility of their research work 43

44. ETHICAL GUIDELINES OF ICMR Ethical guidelines for biomedical research on human participants Executing research policy Guidelines for Good Laboratory Practice National guidelines for accreditation, supervision& regulation of ART clinics in india Cancer management guidelines Guidelines for stem cell research and therapy Guidelines for management of type2 diabetes National guidelines in the management of retinoblastoma ICMR-DBT guidelines for evaluation of probiotics in food Dietary guidelines ICMR should steer international collaborative health research to ensure that the country derives maximum benefit and global goals are attained 44

45. Periodical publications Indian journal of medical research ICMR bulletins Health research policies Guidelines Annual reports of ICMR headquarters &other ICMR institutes and other institutes 45

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