schedule Y

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Detailed description on Schedule Y


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Presentation on SCHEDULE Y:

Presentation on SCHEDULE Y Prepared & Presented by : Sumit Garg (M.Pharm. 1 st sem.) (Pharmaceutics)

Drugs and Cosmetics Act, 1940:

Drugs and Cosmetics Act, 1940 It regulates & control over -: Import Manufacture Sale Distribution Manner of labelling & Packaging of various classes of Drugs and Cosmetics….. Sumit Garg {GRD(PG)IMT}

It also empowers desired authorities:

It also empowers desired authorities To issue licenses for the import, manufacture, sale and distribution of all standard drugs and cosmetics. To have regular inspection of licensed premises by drug inspectors. Sumit Garg {GRD(PG)IMT}

Schedule to Drug Rules:

Schedule to Drug Rules There are two Schedules to the Act and twenty five schedules to the rules. Schedule Y R equirements and g uidelines on clinical trials for import and manufacture of new drug. Simply said it is that drives clinical trial procedures in India…….. Sumit Garg {GRD(PG)IMT}

What is Drug & Cosmetics ?:

What is Drug & Cosmetics ? Drug – articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. Cosmetics - Cosmetics are substances used to enhance the appearance or odor of the human body . Sumit Garg {GRD(PG)IMT}

What is meant by Clinical Trials ?:

What is meant by Clinical Trials ? Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). Sumit Garg {GRD(PG)IMT}

Phases of clinical trials:

Phases of clinical trials Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies . Clinical trials involving new drugs are commonly classified into four phases Phase I - Human/Clinical Pharmacology trials Phase II - Exploratory trials Phase III – Confirmatory trials Phase IV – Post marketing survillence . Sumit Garg {GRD(PG)IMT}

India offers unique opportunities for conducting clinical trials in view of : :

India offers unique opportunities for conducting clinical trials in view of : the large patient pool, well- trained and enthusiastic investigators and premiere medical institutes available in the country considerable low per patient trial cost, as compared to developed countries. Unawareness of health impacts. Sumit Garg {GRD(PG)IMT}

Requirements and guidelines on clinical trials for import and manufacture of new drug:

Requirements and guidelines on clinical trials for import and manufacture of new drug Clinical Trials Nature of trials Permission for trials Responsibilities of Sponsor/Investigator 2. Chemical and Pharmaceutical Information 3. Animal Toxicology Acute toxicity Long-term toxicity Sumit Garg {GRD(PG)IMT}

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Reproduction studies Local toxicity Mutagenicity and Carcinogenicity 4. Animal Pharmacology 5. Human/Clinical Pharmacology trials (Phase I) 6. Exploratory trials (Phase II) 7. Confirmatory trials (Phase III) 8. Special Studies 9. Regulatory status in other countries 10.Marketing Information Sumit Garg {GRD(PG)IMT}


SCHEDULE Y Clinical Trials Nature of trials- The clinical trials 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. Drug already approved/marketed in other countries = Phase III Drug is not approved/ marketed = trials to be initiated at one phase earlier to the phase of trials in other countries. For new drug substances discovered in other countries phase I trials are not usually allowed to be initiated in India For new drug substances discovered in India, clinical trials are required to be carried out in India right from phase I. Sumit Garg {GRD(PG)IMT}

Permission for trials:

Permission for trials Permission to initiate clinical trials with a new drug may be obtained by applying for a test license (TL) to import or manufacture the drug. For new drugs having potential for use in children, permission for clinical trials in the paediatric age group is normally given after phase III trials. However, if the drug is of value primarily in a disease of children, early trials in the paediatric age group may be allowed. Sumit Garg {GRD(PG)IMT}

Responsibilities of Sponsor/ Investigator:

Responsibilities of Sponsor/ Investigator Sponsors are required to submit to the Licensing Authority an annual status report on each clinical trial, namely, ongoing, completed, or terminated. In case a trial is terminated, reason for this should be stated. Any unusual, unexpected, or serious adverse drug reaction (ADR) detected during a trial should be promptly communicated. Sumit Garg {GRD(PG)IMT}

Chemical and Pharmaceutical Information:

Chemical and Pharmaceutical Information Chemical name, code name or number, if any, non-proprietary or generic name, if any, structure, physio-chemical proportion. Dosage form and its composition. Specifications of active and inactive ingredients. Tests for identification of the active ingredient and method of its assay. Outline of the method of manufacture of the active ingredient. Stability data Sumit Garg {GRD(PG)IMT}

Animal Toxicology:

Animal Toxicology Acute toxicity Acute toxicity studies 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 two more route should be used to ensure systemic absorption of the drug. Mortality should be looked for up to 72 hrs after parentral administration and up to 7 days after oral administration . Symptoms, signs and mode of death should be reported, with appropriate macroscopic and microscopic findings where necessary Sumit Garg {GRD(PG)IMT}

Long-term toxicity:

Long-term toxicity Studies should be carried out in at least 2 mammalian species, of which one should be a non-rodent. Duration of study will depend on whether the application is for marketing permission or for clinical trial. In these studies the drug should be administered 7 days a week by the route intended for clinical use in humans. The number of animals required for these studies, i.e. the minimum number on which data should be available. Sumit Garg {GRD(PG)IMT}

Reproduction studies:

Reproduction studies Reproduction studies need to be carried out only if the new drug is proposed to be studied or used in women of childbearing age. Two species should generally be used, one of them being non-rodent if possible. It mainly includes three types of studies …. Fertility studies Teratogenicity studies Perinatal studies Sumit Garg {GRD(PG)IMT}

Local toxicity:

Local toxicity These studies are required when the new drug Is proposed to be used topically in humans. Sumit Garg {GRD(PG)IMT}

Mutagenicity and Carcinogenicity:

Mutagenicity and Carcinogenicity 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.. At least three does levels should be used; the highest does should be sub-lethal but cause observable toxicity; the lowest does should be comparable to the intended human therapeutic does or a multiple of it. Sumit Garg {GRD(PG)IMT}

Animal Pharmacology:

Animal Pharmacology General pharmacological action on other organs and systems, especially cardiovascular, respiratory and central nervous systems. Pharmacokinetic data help to relate the drug effect with plasma concentration and should be given to the extent available. Sumit Garg {GRD(PG)IMT}

Human/Clinical Pharmacology (Phase I).:

Human/Clinical Pharmacology (Phase I). 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 behavior of the drug. carried out in healthy adult males. It is generally unicentric study. Sumit Garg {GRD(PG)IMT}

Explanatory trials (Phase II).:

Explanatory trials (Phase II). In phase II trial a limited number of patients are studied carefully. Normally 10-12 patients should be studied at each dose level. These studies are usually limited to 3-4 centres . Sumit Garg {GRD(PG)IMT}

Confirmatory trials (Phase III).:

Confirmatory trials (Phase III). The purpose of these trials is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients If the drug is already approved/marketed in other countries, phase III data should generally obtained on at least 100 If the drug is a new drug 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 centres . In addition, data on adverse drug reactions observed during clinical use of the drug should be collected in 1000-2000 patients; Sumit Garg {GRD(PG)IMT}

Special Studies:

Special Studies Include studies on solid oral dosage forms, such as bioavailability and dissolution studies. Include studies to explore additional aspects of the drug, e.g. use in elderly patients or patients with renal failure, secondary or ancillary effects, interactions, etc. Sumit Garg {GRD(PG)IMT}

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 precautions, drug interactions, warnings and adverse reactions. The drafts of label and carton texts should comply with provisions of Rules 96 and 97 of the said rules. Sumit Garg {GRD(PG)IMT}

Post-marketing surveillance study. (phase IV):

Post-marketing surveillance study. (phase IV) The importer or manufacturer conducts this study to know further any adverse effect on patients which was not reported during the previous phases of trials. Sumit Garg {GRD(PG)IMT}

Appendix I to Schedule Y :

Appendix I to Schedule Y Introduction Chemical and pharmaceutical information Animal pharmacology Animal toxicology Human/clinical pharmacology (Phase I) Exploratory clinical trials (Phase II) Confirmatory clinical trials (Phase III) Special studies Regulatory status in other countries Marketing information Sumit Garg {GRD(PG)IMT}

APPENDIX II to Schedule Y :

APPENDIX II to Schedule Y Format for submission of Clinical Trial Reports Title of the trial : Name of the investigator and institution : Objectives of the trial: Design of study: Number of patients: Treatments given: drugs and dosage forms: Regimens: Observations made: Results: Discussions of results: Summary and conclusion: Sumit Garg {GRD(PG)IMT}


APPENDIX III FORMAT FOR SUBMISSION OF PRECLINICAL AND CLINICAL DATA FOR r-DNA BASED VACCINES, DIAGNOSTICS AND OTHER BIOLOGICALS SPECIFICATION AND CHARACTERIZATION INFORMATION ON r-DNA VACCINES AND BIOLOGICAL PRODUCTS. Description in details of the method of r-DNA products Description on Identity-Physical, Chemical, Immunological and Biological wherever applicable. Potency General Safety Test. Data on sterility tests as per Indian Pharmacopia guidelines. Data on purity of recombinant product. DATA ON PRECLINICAL TESTING RECOMBINANT IMMUNODIAGNOSTIC REAGENTS. CLINICAL TRIALS Phase I : Human/Clinical Pharmacology Immunogenic Potency Phase II: Exploratory Clinical Trials- Preventive/Therapeutic Efficacy Phase III: Confirmatory Trials Sumit Garg {GRD(PG)IMT}


APPENDIX IV INVESTIGATOR’S BROCHURE (IB) Introduction Contents of the IB: Table of contents Introduction Physical, chemical, and pharmaceutical properties and formulation parameters Non-clinical Studies The following section should discuss the following… Non-clinical Pharmacological ( Pharmacodymanics ) Pharmacokinetics and Product Metabolism in Animals Toxicology Effects in Humans Pharmacokinetics and Product Metabolism in Humans Safety and Efficacy Regulatory & Post-marketing Experiences Sumit Garg {GRD(PG)IMT}


APPENDIX V ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL The various Essential Documents needed for different stages of the study are classified under three groups… before the clinical phase of the study commences, during the clinical conduct of the study, and after completion or termination of the study. Sumit Garg {GRD(PG)IMT}

APPENDIX V to Schedule Y :

APPENDIX V to Schedule Y It includes following forms……. Patient consent form for participation in a Phase I Clinical Trial Patient consent form for participation in Phase II and Phase III Clinical Trial Sumit Garg {GRD(PG)IMT}

APPENDIX VI to Schedule Y :

APPENDIX VI to Schedule Y Data requirements of Fixed Dose Combinations Fixed Dose combinations (FDC) fall into four groups and their data requirements accordingly. The first group of FDC includes those in which one or more of the active ingredients is a new drug. The second group of FDC includes those in which active ingredients already approved/marketed . The third group of FDC includes 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. The fourth group of FDC includes those whose individual active ingredients have been widely used. Sumit Garg {GRD(PG)IMT}


References Sumit Garg {GRD(PG)IMT}

Thank You !!!!!:

Thank You !!!!! And Have a Nice Day……. Sumit Garg {GRD(PG)IMT}

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