Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

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REGISTRATION OF ETHICS COMMITTEE Regulations for conducting clinical trials in the country are prescribed under Rule 122DA, 122DAA, 122DAB, 122DAC, 122DD,122E and Schedule Y to the Drugs & Cosmetics Rules, 1945. The Drugs & Cosmetics Rules have been amended vide GSR no. 72 (E) dated 08-02-2013 inserting a Rule 122DD, in Schedule ‘Y’ along with other amendments. The amendment specifies the detail procedures for the registration of Ethics Committee. As per Rule 122DD, No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with DCG(I). An application for registration of Ethics Committee shall be made to the DCG(I) in accordance with the requirements as specified in the Appendix VIII of Schedule Y. In order to streamline the submission of application for registration of Ethics Committee and their examination as per Rule 122DD, it has been decided to introduce a system of preliminary scrutiny of such applications at the time of their receipt, to determine their acceptability for examination by CDSCO. During the preliminary examination, the CDSCO officer(s) will scrutinize the application to ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist provided. If the applications are not submitted in accordance with the format and the checklist, it will not be accepted by CDSCO for further examination. Once an application is accepted, the information in the application will be reviewed by CDSCO as per the specified procedures. i. The Ethics Committee is requested to prepare the application for submission to CDSCO as per appendix-VIII of Schedule-Y of D&C Rules and the checklist alongwith undertaking by the committee as per the suggested format. ii. iii. iv. The application must be submitted with indexing and page number. Without indexing or page number, no application will be accepted. Clear and unequivocal information should be provided in the application. Text and tables should be prepared using margins that allow the document to be printed clearly without losing any information and the left-hand margin should be sufficiently large so that information is not obscured by the method of binding. The documents printed on both sides of a page, can be submitted provided, however, one should take care that the information is not obscured when the page is placed in a binder. v. While submitting reply to a query, the applicant should always enclose with the reply, a copy of query letter issued by CDSCO. vi. All items mentioned in the checklist may not be applicable. The items not relevant to a particular application should be marked with “Not Applicable (NA)”. This system of preliminary scrutiny is to determine the acceptability of the application for registration of ethics committee have come into effect from 25.02.2013. CDSCO has now started giving the registration number w.e.f. 1st April 2013, and the information is being regularly updated on its website. (For more details, visit CDSCO website www.cdsco.nic.in) Ancient Wisdom A person should refrain from all those things that take him towards fallacy, misery, ignorance and degradation. Everybody should work hard to achieve success, growth and prosperity. But, this can be possible only when our health is good. Atharva Veda Atharva Veda info Ayurveda, Volume 2, No.5, July - Sept’ 2013 4
GOOD CLINICAL PRACTICE GUIDELINES FOR CLINICAL TRIALS IN AYURVEDA, SIDDHA AND UNANI MEDICINE (GCP-ASU) Department of AYUSH www.indianmedicine.nic.in March 2013 Ministry of Health & Family Welfare Government of India, New Delhi The department of AYUSH is planning to introduce a regulation for clinical trials for Ayurveda, Siddha and Unani Medicine and have issued Good Clinical Practices (GCP) guidelines document for clinical trials in Ayurveda, Siddha and Unani (ASU) medicines which will facilitate the researchers and institutions in adopting a standard way of good clinical practice while conducting the ASU clinical trials. The guidelines at present are a guiding tool and for voluntary use and reference and do not bear any connotation of legal binding, but will be superseded by regulatory provisions as and when brought in. Good Clinical Practice is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The objective of the document is to encourage that clinical studies in ASU systems are undertaken in accordance with ethical and scientific standards and safety aspects and rights of participants are protected. Adhering to methodical documentation of trials will help bringing credibility to the efforts of persons and institutions involved in the process, which otherwise was lacking for want of any ASU-specific guiding document. The guidelines are significant as although the ASU systems are known for their long history of safe and effective use, yet validation of safety and efficacy using scientific and evidencebased methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners and satisfaction of end users in the products. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated. This guideline is based on CDSCO Document on GCP Guidelines (2001) for Clinical trials on Pharmaceutical products and covers the major headings as follows: i. Protocol - Relevant components of Protocol, General Information, Objectives and Justification, Ethical Considerations, Study design, Inclusion, Exclusion & Withdrawal of Subjects, Handling of the Product(s), Assessment of Efficacy and Safety, Statistics, Finance and Insurance, Publication policy etc ii. Ethical & Safety Considerations - Ethical Principles, Ethics Committee & its responsibilities, Composition, Review Procedures , Submission of Application, Record Keeping etc iii. Informed Consent Process - Informed Consent of Subject, Essential information, Research subjects, Confidentiality, Compensation for participation or injury, Pregnant or nursing women, Children, Vulnerable groups etc iv. Responsibilities of Sponsor - Investigator and Institution Selection, Contract, SOP, Allocation of duties and responsibilities, Study management, Data handling and Record keeping, Compensation for participation, Information on Investigational Products, Supply, Storage and handling of ASU drug/Patent or Proprietary Medicines, Safety Information, Adverse Drug Reaction Reporting, Study Reports, Monitoring, Audit etc v. Responsibilities of Investigator - Qualifications, Medical care of the study subjects, Monitoring and Auditing of records, Communication with Ethic Committee, Compliance with the protocol etc vi. Responsibilities of Monitor vii. Record Keeping & Data Handling - Documentation, Corrections, Electronic Data Processing, Validation viii. Role of Biostatistician - Study Design, Randomization and Blinding, Statistical Analysis etc ix. Clinical Trials of Contraceptives, Therapies/Surgical Procedures/Medical devices. x. Appendix - Guidelines for Evaluation of Ayurveda, Siddha and Unani Medicine, Ethical Issues (Ethical Guidelines for Biomedical Research Human Participants, Indian Council of Medical Research 2006, Investigator’s Brochure, Essential Documents) (For more details on the guideline visit the website of AYUSH www.indianmedicine.nic.in) info Ayurveda, Volume 2, No.5, July - Sept’ 2013 5
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Page 3: Regulatory Update REGISTRATION OF C
Page 7 and 8: STORAGE Store in a cool place in ti
Page 9 and 10: BRIEF REVIEW ON ASHWAGANDHA (Withan
Page 11 and 12: urinary stones and hemorrhagic dise
Page 13 and 14: Double Blind Randomized Placebo Con
Page 15 and 16: 3.6. TOLERANCE The drug was well to

Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

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