Professional Documents
Culture Documents
Presented By-MANISH KUMAR SHARMA Presented To CENTER FOR CLINICAL RESEARCH SHARDA UNIVERSITY, GREATER NOIDA,UP
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Outline of Presentation
1. History 2. Drug and cosmetic Act,1940 and Schedules 3. What actually Schedule Y is ? 4. Old/New(amended) Schedule Y 5. Why Changes in Schedule Y ? 6. Rules under it 7. Divisions of Schedule Y
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Act) Pharmacy Act , 1948 Drug and Magic Remedies Act, 1954 The Narcotic and Psychotropic Substance Act and Rules, 1985 Ethical guidelines for Biomedical Research on Human Participants,2000 by ICMR
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Act,2002 Revised Schedule Y, 2005 Guidelines for Pre Clinical Data for r-DNA Vaccines,2007
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M-GMP N-List of minimum equipment in Pharmacy O-Standards for disinfections P- Life period of drug Q-List of dyes/coloring agents in soap/cosmetics R-Standards for Mechanical contraceptives S-Standards for cosmetics T-GMP for A/U/S system of medicines U- Records for manufacturing/raw materials in drugs V- Standards for potent medicines X- List of drugs whose I/M/S are governed by special provision W- Omitted Y- About CT
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Schedule Y
The enforcement that came into existence in 1988 was an essential
provision for providing support to the upscale of generic pharma scenario present in those days. With the entry of large pharmaceutical companies along with the multiple multinationals in field of clinical research the needs changed and a revised version of Schedule Y in line with ICH-GCP (International Council of Harmonization and Good Clinical Practice) standard was put forth in 1995. Since then multiple revisions to Schedule Y took place to provide a healthy environment for clinical research to be conducted in India.
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Schedule Y
Schedule Y
Schedule Y ,the current regulator (of
CDSCO), enforced law in India has been established under Drug and Cosmetic Act,1945. The regulations to be followed when conducting Clinical Trial in India.
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contt..
REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS IN INDIA
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Amended Schedule Y
Regulations and Guidelines for permission for development (preclinical and/or clinical), import and manufacture of New Drugs for Marketing in India DATE- 20TH JAN,2005
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research. CDSCO and DTAB formulated GCP under Schedule Y in 2005. Schedule Y 1988 relevant to predominantly generic industry. GCP trials since 1995, and arrival of IPR regime in 2005. Integration of India in global clinical development and legal support to GCP guidelines. Improvements in quality of clinical trials. It has outlined extensive study criteria in line with the globally accepted formats such as ICH and US FDA guidelines.
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122 DA
122DAA
122 E
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122-E.
122-E. -Not been used in the country under labeling
conditions Approved but now proposed to be marketed with modified or new claims indications, dosage, dosage form , route of administration-FDC, individually approved, to be combined for the first time in a fixed ratio or if ratio is changed
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Old schedule Y
in the older version there are only 5 appendices Appendix I: Declaration of Helsinki Appendix II: Schedule Y Appendix III: Format for submission of Pre-clinical and clinical data for r-DNA based vaccines, diagnostics and other biologicals. Appendix IV: Investigators Brochure Appendix V: Essential Documents
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Significant changes
New concept
1)Clinical trials a) Definition of CT b) ICD New c) responsibilities of ethical committee- New d) PMS- New 2) Studies in special populations a) Geriatric b) Pediatrics c) Pregnant d) PMS - New e) BA/BE - New 3)Formats for critical documents
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Older concept
1.1 Nature of CT 1.2 Permission of CT 1.3 ICD but no details 1.4 Responsibilities of sponsor/investigator No PMS 2) Special Studies No Separation
Appendix I Data to be submitted along with the application to conduct clinical trials / import / manufacture of new drugs for marketing in the country.
a.
b.
c. d.
e.
f. g.
h.
i. j.
Introduction about the drug Chemical and pharmaceutical information (e.g. Enatiometry) Animal pharmacology Animal toxicology Human /clinical pharmacology(Phase-I) Therapeutics exploratory(Phase-II) Therapeutics confirmatory(Phase-III) Special studies( paediatrics, pregnant) Regulatory status in other countries if available Prescribing information(drug labeling and prescribing inf.)
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APPLICATION FOR PERMISSION UNDER FORM 44, REGULATORY AUTHORITIES, FEES AND TEST LICENCE
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Regulatory authorities
Ministry of Chem & Fertilizers
Ministry of Health Health Secretary NPPA National Pharmaceutical Pricing Authority Pricing Regulations DGHS Director General of Health Services DCGI Drug Controller General of India CDRL/CDTL Gov. Drug Testing Laboratories State Drug Regulatory Authority :FDA DBT Department of Biotechnology Additional Secretary Ministry of Sci & Tech Ministry of Enviro
PROCESS
APPLICATION FORM 44 -Imp FF -Imp Rm -Mfg FF -Mfg Rm -CT Approval Form 45 (IMP FF)
= Rs 50,000/-
of new drug
Application by same applicant,
= Rs 15,000/-
year of approval
= Rs 15,000/= Rs 15,000/-
Phase I = Rs 50,000/Phase II = Rs 25,000/Phase III = Rs 25,000/No separate fee to be paid along with application for import / mfg based on successful completion
Appendix I-A
Data required to be submitted by an applicant for grant of permission to import &/or manufacture a new drug already approved in the country.
a) Introduction
b) Chemical and pharmaceutical information c) Marketing information d) Special studies
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3) 4) 5) 6) 7)
Name and address of the medical college, hospital or other facility where the clinical trial will be conducted: Education, training &experience that qualify the Investigator for the clinical trial (Attach details including Medical Council registration number, and / any other statement of qualification Name and address of all clinical laboratory facilities to be used in the study. Name and address of the Ethics Committee ,responsible for approval and continuing review of the study. Names of the other members of the research team (Co- or sub-Investigators) who will be assisting the Investigator in the conduct of the investigation. Protocol Title and Study number (if any) of the clinical trial to be conducted by the Investigator. Signature with Date.
Indian GCP
Fairly small (5-7 members). 1 member from nonscientific area
Schedule-Y
At least 7 members.
Not Explained. The quorum should have at least 5 The quorum should have a members. Maximum number is minimum of 5 members. not detailed. 12 to 15 is the maximum recommended number. Not recommended. Member Secretary belongs to the same Institution.
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STABILITY TESTING
Stress testing of the drug substance should be conducted to identifya. The degradation pathways b. Evaluate the intrinsic stability of the molecule and c. Validate the stability indicating power of the analytical procedures used. Stress testing may generality be carried out on a single batch of the drug substance. It should include the effect of-Temperature, humidity, oxidation, photolysis on the drug substance. TWO TYPES OF STUDY IS DONE 1)Long-term testing should cover a minimum of 12 months duration on at least three primary batches of the drug substance or the formulation at the time of submission
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STABILITY TESTING
2)Accelerated testing should cover a minimum of 6 months duration at the time of submission. Study conditions for drug substances and formulations intended to be stored under general conditions.
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Title page Table of content a) a) introduction b) Study rationale c) Study design d) Study population e) Subject eligibility f) Study treatment g) AE h) Data analysis i) Undertaking by investigator
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Schedule Y-1-Requirements and Guidelines for registration of clinical research organisations 2. Criteria for Registration
(I) The Clinical Research Organisation shall be under the charge of a person who is responsible for the overall activities of the organisation. He shall be thoroughly familiar with the investigational product(s), the protocol, written informed consent forms or other information provided to the subjects, the standard operative procedures by the sponsors, GCP guidelines and other rules applicable to the conduct of clinical trials. (ii) The organisation shall have adequate resources, qualified and trained staff for oversight of clinical trials. The staff members are required to be trained regularly to update their skills.
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(iii) 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. (iv) The organisation shall implement quality assurance and quality control as per standard operative procedures designed for the purpose. Such SOPs shall be well documented.
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1)Rule 122-DAB- compensation during injury or death during clinical trial In case of injury in clinical trial the compensation is based as per the recommendation of EC/IRB , it may be financial or medical. 2) In case of death his/her legal heirs are entitled for the financial compensation, subject to the confirmation to EC
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Conclusion
With the Schedule Y, efforts are aligned in a single direction to ensure that irrespective of the country, the data generated is of good quality and standard which can be accepted worldwide
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References
Gupta S.K, Basic principles of Clinical research and Methodology, 2007.
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QUERIES????
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