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Schedule y is the requirement and guidelines for permission to import and/or manufacture of new drugs for sale or to undertaken clinical trails in India. simply said, it is that drives clinical trails in india.Slide 3: Application for permission to undertake clinical trials (IND) shall be made in form 44 to the licensing authority (DCGI) along with…… Chemical and pharmaceutical information Animal toxicology Animal pharmacology Human/clinical pharmacologySlide 4: Explanatory trials Confirmatory trials Special studies Submission of reports Regulatory status in other countries Marketing information Post-marketing surveillance studyClinical trails: Clinical trails Clinical trail is a systemic study of a new drug in human subject to generate data for discovering or verifying; Nature of trails Permission for trials Responsibilities of sponsor/investigatorSlide 6: NATURE OF THE TRAILS the clinical trails required to be carried out in the country before a new drug is approved for marketing depend on the status of the drug in other countries. if the drug is already approved/marketed, usually the phase III trials are required. if the drug is not approved/marketed trials are generally allowed to be at one phase earlier to the phase of trials in other countriesSlide 7: PERMISSION FOR TRAILS permission to initiate clinical trials with a new drug may be obtained by applying in form 12 for test licence (TL) to import or manufacture the drug under the rules. permission to carry out clinical trials with a new drug is issued along with a test licence in form11. SPONSOR RESPONSINILITIES implementation and maintenance of QA system to ensure that the: trail is conducted Data generated Documented ReportedSlide 8: In compliance with the standards: Protocol GCP guidelines issued by CDSCO Statutory provisions (regulations) SOPs. SOPs should be documented to ensure compliance with GCP and applicable regulations. Submit study status report to the licensing authority at prescribed periodicity. In case of premature termination of the study for any reason, a summary study status report should be submitted to the licensing authority with in 3 months. Any unexpected, serious adverse event occurring in a clinical trail should be communicated with in 14 days by sponsor to the licensing authority and other participating investigators in the study.Slide 9: INVESTIGATOR RESPONSIBILITIES: Investigator shall be responsible for the conduct of the trial as per protocol, GCP and also for compliance as per the undertaking given. SOPs are required to be documented by the investigators for the tasks performed by them. Investigator should ensure adequate medical care to the subject for any adverse events. Investigator shall report all serious and unexpected adverse events to the sponsor within 24 hrs and the EC with in 7 working days.CHEMICAL AND PHARMACEUTICAL INFORMATION: CHEMICAL AND PHARMACEUTICAL INFORMATION Most of the data under the heading are required with the application for marketing permission. When the application is for clinical trials only. Information covered in appendix I will usually suffice.ANIMAL TOXICOLOGY: ANIMAL TOXICOLOGY ACUTE TOXICOLOGY: it should be carried out in at least two species usually mice and rats using the same route as intended for humans. In addition, at least one more route should be used to ensure systemic absorption of the drug. LONGTERM TOXICITY: long term toxicity should be carried out in at least two mammalian species. In which one should be a non rodent. The duration of study will depend on whether the application is for marketing permission or for clinical trialSlide 12: REPRODUCTION STUDIES: it need to be carried out only if the new drug is proposed to be studied or used in women or childbearing age. two species should generally be used, one of them being a non-rodent if possible. Fertility studies; the drug should be administered to both males and females, beginning a sufficient number of days before mating. In females the medication should be continued after mating and the pregnant one should be treated throughout pregnancy. Teratogenicity studies: the drug should be administered throughout the period of organogenesis, using three dose levels.Slide 13: c)Perinatal studies; the drug should be administered throughout the last third of pregnancy and then through lactation of weaning. The control of each treated group should have at least 12 pregnant females and the dose which cause low foetal loss should be continued throughout lactation weaning. animal should be sacrificed and observations should include macroscopic autopsy. d) Local toxicity: these studies are required when the new drug is proposed to be used topically in humans.Slide 14: Mutagenicity and carcinogenicity: these studies are required to be carried out if the drug or its metabolite is related to a known carcinogen or when the nature and action of the drug is such as to suggest a carcinogenic/mutagenic potential. For carcinogenicity studies, at least two species should be used. And at least three dose level should be used.ANIMAL PHARMACOLOGY: ANIMAL PHARMACOLOGY Specific pharmacological actions are those with therapeutic potential for humans. These should be described according to the animal models and species used. General phrmacological actions are effects on other organs and systems, specially cardiovascular, respiratory and CNS. The pharmacokinetic data help relate drug effect to plasma concentration and should be given to the extent available.HUMAN/CLINICAL PHARMACOLOGY: HUMAN/CLINICAL PHARMACOLOGY The objective of phase I of trials is to determine the maximum tolerated dose in humans; pharmacodynamic effects; adverse reactions, if any, with their nature and intensity; and pharmacokinetic behaviour of the drug as far as possible. These studies are carried out in healthy adult males, using clinical, physiological and biochemical observations. At least 2 subjects should be used on each dose. Phase I trials are carried out by investigators trained in clinical pharmacology.EXPLANATORY TRIALS: EXPLANATORY TRIALS In phase II trial a limited number of patients are studies carefully to determine possible therapeutic use, effective dose range and further evaluation of safety and pharmacokinetics. Normally 10-12 patients should be studied at each dose level. These studies are usually limited to 3-4 centres and carried out by clinicians specialized in the concerned therapeutic areas.CONFIRMATORY TRAILS: CONFIRMATORY TRAILS The purpose of these trials is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. If the drug is already approved/marketed in other countries, phase III data should generally obtained on at least 100 patients distributed over 3-4 centers. If the drug is a new substance discovered in India and not marketed in any other country, phase III data should be obtained at least 500 patients distributed over 10-15 centers.SPECIAL STUDIES: SPECIAL STUDIES These include studies on solid oral dosage form, such as, bio-availability and dissolution studies. These are required to be submitted on the formulations manufactured in the country. These include studies to explore additional aspects of drug. e.g ; use in elderly patients or patients with renal failure, secondary or ancillary effects, interactions, etc.SUBMISSION OF REPORTS: SUBMISSION OF REPORTS These reports of completed clinical trials shall be submitted by the applicant duly signed by the investigator with a stipulated period of time. The applicant should do so even if he is no longer interested to market the drug in the country unless there are sufficient reasons for not doing so.REGULATORY STATUS IN OTHER COUNTRIES : REGULATORY STATUS IN OTHER COUNTRIES It is important to state if any restrictions have been placed on the use of the drug in any other country, e.g; dosage limited, exclusion of certain age groups, warnings about adverse drug reactions,etc.MARKETING INFORMATION: MARKETING INFORMATION The product monograph should comprise the full prescribing information necessary to enable a physician to use the drug properly. It should include description, actions, indications, dosage precaution, drug interactions, warnings and adverse reactions.POST MARKETING SURVEILLANCE STUDY: POST MARKETING SURVEILLANCE STUDY On approval of a new drug, the importer or the manufacturer shall conduct post-marketing surveillance study of that new drug after getting the protocols and the names of the investigators approved by the licensing authority as defined under clause (b) of rule 21 during the initial period of two years of marketing.SCHEDULE ‘Y’ APPENDIES: SCHEDULE ‘Y’ APPENDIES Data required to be submitted with application for permission to market a new drug. I-A. Data required to be submitted by an applicant for grant of permission to import manufacture an already approved new drug. Format for submission of clinical trial reports. Animal toxicity requirements for clinical trials and marketing of a new drug. Number of animals for long term toxicity studies.Slide 25: Patient consent form for participation in a phase I clinical trail. Fixed dose combination (FDC) fall into groups and their data requirements accordingly. Undertaking by the investigator. Ethics committee. Stability testing of new drugs. Contents of the proposed protocol for conducting clinical trials. Data elements for reporting serious adverse events occurring in clinical trial.Slide 26: thank you You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.