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Schedule Y


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Schedule Y amended version 2005, …

Schedule Y amended version 2005,
I hope this is useful to All Clinical Research Professionals.
-Thank You

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    • 1. SCHEDULE Y( AMENDED VERSION2005) Prepared By Kamalakar Ambati
    • 2. LEARNING OBJECTIVES Regulatory Framework of India Organization Important sections of Schedule Y Appendices 2 Prepared By Kamalakar Ambati
    • 3. INDIAN REGULATORYPROCESSES & LAWS The Main regulatory laws operating in India are the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics Rules (1945). The Act and Rules are binding on allopathic and other systems of medicine and regulate imports, manufacture, distribution, and sale of drugs in India. 3 Prepared By Kamalakar Ambati
    • 4. ORGANIZATION The New Drug Regulatory Process come under the purview of the Drugs Controller General of India (DCGI), who is the head of the Central Drugs Standard Control Organization (CDSCO), located in New Delhi. 4 Prepared By Kamalakar Ambati
    • 5. REGULATORY FRAMEWORK OF INDIAMinistry of Chem & Ministry of Health Ministry of Sci & Ministry of Fertilizers Tech Enviro Health Secretary DBT NPPA DGHS Department of Additional National Director General of Biotechnology Secretary Pharmaceutical Health Services Pricing Authority GEAC DCGI Genetic Drug Controller Engineering Pricing General of India Approval Regulations Committee CDL/CDTL Gov. Drug Testing Laboratories 5 State Drug Regulatory Authority :FDA By Kamalakar Ambati Prepared
    • 6.  The DCGI is supported by various bodies, such as the Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) in the evaluation of specific therapies or clinical trials. The ICMR, for example, provides expert advice in evaluation of Phase I trials or clinical trials relevant to national priorities, eg, malaria, AIDS etc. There are also committees, such as Drugs Consultative Committee and Drugs Technical Advisory Board, which support the DCGI in assessing new drug applications. 6 Prepared By Kamalakar Ambati
    • 7. REGULATORY FRAMEWORK DGFT( Directorate General of Foreign Trade ( Ministry of Commerce and Industry)  Responsible for Export of Biological Samples out of the country for analysis 7 Prepared By Kamalakar Ambati
    • 8. SCHEDULE Y Requirements and guidelines for permission to import and/ or manufacture of new drugs for sale or to undertake clinical trials. Earlier version 1985. Amended in 2005, another amendment due now. 8 Prepared By Kamalakar Ambati
    • 9. Proposed Changes ( 1985 vs 2005)• Clinical trials – definition, conduct Responsibilities of Ethics Committee (EC), Investigator and SponsorFormats for critical documents 9 Prepared By Kamalakar Ambati
    • 10. Clinical TrialsDefinition of Phases I – IVConcurrent Phase II-III 03 5 24 AugCentral lab and trial samples Classification of Fixed Dose Combinations for clinical studies 10 Prepared By Kamalakar Ambati
    • 11. STRUCTURE & CONTENTS The 2005 version of Schedule Y has three major sections and 11 appendices. 1. Application for Permission 2. Clinical Trial 3. Studies in Special populations 11 Appendices 11 Prepared By Kamalakar Ambati
    • 12. Application for PermissionThis section covers the information on data required for clinical trial application (CTA) and refers to relevant appendices for documents/ data to be submitted.Application to import or manufacture new drugs for sale or to undertake CT shall be made in Form 44. 12 Prepared By Kamalakar Ambati
    • 13. IMPORT LICENSE Application to import drugs for use in clinical trials must be submitted at the same time as the regulatory approval application. The application, submitted on Form 12 of the D & C Rules, should give a detailed calculation of the quantity of drugs required for the study and from which country the drugs are to be imported. The drug licensing authority, the DCGI issues a “Test License” ( “T License”) on Form 11 of the Drugs and Cosmetic Rules for the import of drugs. T License is obtained along with the permission for the clinical trial. Hence, it is not allowed to import a drug without DCGI approval and T License. A T License is valid for one year 13 Prepared By Kamalakar Ambati
    • 14. CLASSIFICATION Clinical trials are now classified into two categories – A and B –  Category A comprising clinical trials for which a protocol has already been approved in specific regulated countries such as the US, the UK, Australia, Canada and Japan. Average of 20 applications per month Time for approval: two to four weeks.  All other applications fall under Category B. India and developing countries/market locations Time taken estimated eight to six to sixteen weeks. 14 Prepared By Kamalakar Ambati
    • 15.  For a new drug substance discovered in India, the sponsor can initiate a Phase I clinical trial. However, for new drug substances discovered outside India, Phase I data from other countries are required to be submitted along with the application. 15 Prepared By Kamalakar Ambati
    • 16.  The DCGI may grant permission to repeat Phase I and/or to conduct Phase II trials and subsequent Phase III concurrently with other global trials for that drug. Phase III trials mandatory for obtaining permission to market the drug in India. 16 Prepared By Kamalakar Ambati
    • 17. Clinical TrialThis section includes 1. DCGI and EC approvals for initiating trial, investigator qualifications and site details, central laboratory details, protocol amendments, 2. Responsibilities of sponsors, 3. Responsibilities of investigators 4. Informed consent process 5. Responsibilities of Ethics Committee 6. Definitions and objectives of different phases of trials( I, II, III and IV). Earlier Schedule Y did not have such clear cut sections… 17 Prepared By Kamalakar Ambati
    • 18. EC APPROVAL Applications for regulatory and ethics committee approval of a protocol may be submitted simultaneously. ECs can grant a conditional approval, i.e. on obtaining NOC from DCGI, same can be notified to EC and proper approval can be given the next day ( Earlier Schedule Y mentioned, DCGI permission first and then EC submission) Also, Trial Sites may accept the approval granted to the protocol by the ethics Committee of another trial site or the approval granted by an independent ethics committee. This provision was not there in earlier Schedule Y 18 Prepared By Kamalakar Ambati
    • 19. PROTOCOL AMENDMENTS With a view to further streamlining the protocol review process, categories have been introduced for protocol amendments. Amendments which require notification to the licensing authority but need not wait for permission additional investigator sites; change in investigator with a documented reason why earlier one has withdrawn( if applicable) Amended investigator brochure, amended informed consent Administrative and logistic changes Minor protocol amendments and additional safety assessments where the ethics committee has already approved the changes. 19 Prepared By Kamalakar Ambati
    • 20.  Amendments which require prior permission of the licensing authority:  additional patient recruitment;  major changes in protocol with respect to study design, dose and treatment options; and  any change in inclusion or exclusion criteria. 20 Prepared By Kamalakar Ambati
    • 21. Phases of trials The section covers objectives and scope of Human pharmacology (Phase I), Therapeutic exploratory trial (Phase II), Therapeutic confirmatory trial (Phase III) Post-marketing trials (Phase IV).Earlier Schedule Y had less emphasis on the objective and more on the no. of subjects 21 Prepared By Kamalakar Ambati
    • 22. POST MARKETINGSURVEILLANCE  New Drugs should be closely monitored for their Clinical safety once they are marketed.  This includes the requirement for submission of periodic safety update reports (PSURs), PSUR cycle, template for PSUR, and the timelines  PSURs shall be submitted every 6 months for the first two years after approval. For subsequent two years – the PSURs need to be submitted annually.  Serious unexpected adverse reactions, must be reported to LA within 15 days of knowledge of applicant. 22 Prepared By Kamalakar Ambati
    • 23.  Studies in special populationsThis section covers clinical trials in geriatric and pediatric populations, and in pregnant or nursing women.Bioavailability/ Bioequivalence StudiesStill, this area needs to be clearly defined. 23 Prepared By Kamalakar Ambati
    • 24.  With an objective of bringing uniformity in trial processes, the new Schedule also provides formats of critical documents, eg, informed consent documents, study reports, EC approvals, reporting of serious adverse events etc. 24 Prepared By Kamalakar Ambati
    • 25. SCHEDULE Y1 Rule 122 DAB. – Registration of clinical research organization for conducting clinical trials.  CRO shall perform functions if it is duly registered, under the rules, by the Licensing Authority defined in Clause (b) of Rule 21.  An application for registration of clinical research organization shall be made to the said authority accompanied by the information as required under Schedule Y-1.  A registration, unless it is sooner suspended or cancelled, shall be valid for a period of five years from the date of issue. 25 Prepared By Kamalakar Ambati
    • 26. REQUIREMENTS AND GUIDELINES FOR REGISTRATIONOF CLINICAL RESEARCH ORGANISATIONS ( CRO)Scope  These guidelines cover all organisations, individuals, institutions and companies that takes the responsibility of the initiation or management or coordination of a clinical trial. It does not include clinical trial sites. 26 Prepared By Kamalakar Ambati
    • 27. Criteria for Registration (i) The CRO shall be under the charge of a person who is responsible for the overall activities of the organisation. (ii) The organisation shall have adequate resources, qualified and trained staff for oversight of clinical trials. (iii) The trial related duties and functions transferred to and assumed by the CRO shall be specified in writing and properly quantified. (iv) The organisation shall ensure that the trials are adequately monitored and the trial related responsibilities transferred to it, partially or fully, by the sponsor are discharged effectively and efficiently. (v) The organisation shall implement quality assurance and quality control as per standard operative procedures designed for the purpose. Such SOPs shall be well documented. 27 Prepared By Kamalakar Ambati
    • 28. (viii) An undertaking to declare that (a) We shall comply with the conditions imposed on the registration certificate along with the adherence to other guidelines like GCP guidelines and provisions of the Drugs and Cosmetics rules, 1945. (b) We shall comply with such further requirements, if any, as may be specified by the Government of India, under the Act and the rules, made thereunder . (c) We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted by us for which the registration certificate has been made. 28 Prepared By Kamalakar Ambati
    • 29. 4. INFORMATION REQUIRED FORREGISTRATION (i) Name and address of the organisation (ii) Name and address of the proprietors/partners/directors. (iii) Status of the organisation as legal entity. (iv) A brief profile of the specific activities/services undertaken by the organisation including facilities, resources and infrastructure. (v) An organogram of the organisation including brief CVs of key personal. (vi) List of SOPs with salient highlights about specific areas to be scrutinised. (vii) Copy of the contract between the sponsor and the organisation. 29 Prepared By Kamalakar Ambati
    • 30. SCHEDULE Y1 CONTD…vi) The organisation should check the accuracy and completeness of the data/documents and other related records and ensure that the investigator(s) have maintained the essential documents required for the conduct of the trial.(vii) The organisation shall ensure that the investigator(s) received all documents and trial related supplies needed to conduct the trial properly.(viii) The organisation shall have education programmes to help its investigators to carry out the research studies as per guidelines applicable to such trials. 30 Prepared By Kamalakar Ambati
    • 31. RESTRUCTURING FRAMEWORK 31 Prepared By Kamalakar Ambati
    • 32. CONSTRAINTS  Regulatory Evaluation Capacity  Regulatory inspections capacity  Special Products like Devices, Diagnostics etc  No supervision over ECs in India  Lack of Regulatory Inspections 32 Prepared By Kamalakar Ambati
    • 33. SYNOPSISClinical trial – rationalization for globalizationEthics committee – DC for ECInformed consent – torture of additional signaturesInvestigator – overtaken by undertakingSponsor – Audit-ory hallucinations of compliance to ICH- GCP and Indian GCP 33 Prepared By Kamalakar Ambati
    • 34. REFERENCES 34 Prepared By Kamalakar Ambati