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The Ethics Committee shall be open to inspection by the officers authorized by the Central Drugs Standard Control Organization, who may include an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y, Good Clinical Drugs and Cosmetics Rules, 1945 626 Practice guidelines and other applicable regulation for safeguarding the rights, safety and well-being of the trial subjects.] III. Format for According Approval to clinical trial protocol by the Ethics Committee.] To Dr. Dear Dr. The Institutional Ethics Committee / Independent Ethics Committee (state name of the committee, as appropriate) reviewed and discussed your application to conduct the clinical trial entitled ―……‖ on …….(date). The following documents were reviewed: (a) Trial Protocol (including protocol amendments), dated Version no (s). (b) Patient Information Sheet and Informed Consent Form (including updates if any) in English and/or vernacular language. (c) Investigator‘s Brochure, dated , Version no. (d) Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose. (e) Principal Investigator‘s current CV. (f) Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation. (g) Investigator‘s Agreement with the Sponsor. (h) Investigator‘s Undertaking (Appendix VII). The following members of the ethics committee were present at the meeting held on (date, time, place). Chairman of the Ethics Committee Member secretary of the Ethics Committee Name of each member with designation We approve the trial to be conducted in its presented form. The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report. Yours sincerely, Member Secretary, Ethics Committee. Drugs and Cosmetics Rules, 1945 627 APPENDIX IX STABILITY TESTING OF NEW DRUGS Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity and light, and to establish shelf life for the formulation and recommended storage conditions. Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. In case of formulations the testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system). Validated stability-indicating analytical procedures should be applied. For long term studies, frequency of testing should be sufficient to establish the stability profile of the drug substance. In general, a drug substance should be evaluated under storage conditions that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the length of studies chosen should be sufficient to cover storage, shipment and subsequent use. Stress testing of the drug substance should be conducted to identify the likely degradation products, which in turn establish the degradation pathways, evaluate the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of formulation involved. Stress testing may generally be carried out on a single batch of the drug substance. It should include the effect of temperatures ), humidity where appropriate, oxidation, and photolysis on the drug substance. Data should be provided for (a) Photostability on at least one primary batch of the drug substance as well as the formulation, as the case may be and (b) the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension. 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 and should be continued for a period of time sufficient to cover the proposed shelf life. Accelerated testing should cover a minimum of 6 months duration at the time of submission. In case of drug substances, the batches should be manufactured to a minimum of pilot scale by the same synthetic route and using a method of manufacture that simulates the final process to be used for production batches. In case of formulations, two of the three batches should be at least pilot scale and the third one may be smaller. The manufacturing process(es) used for primary batches should simulate that to be applied to production batches and should provide products of the same quality and meeting the same specifications as that intended for marketing. The stability studies for drug substances should be conducted either in the same container - closure system as proposed for storage and distribution or in a container - closure system that simulates the proposed final packaging. In case of formulations, the stability studies should be conducted in the final container - closure system proposed for marketing. Stability Testing of new drug substances and formulations: (i) Study conditions for drug substances and formulations intended to be stored under general conditions Drugs and Cosmetics Rules, 1945 628 Study Study conditions Duration of study Long term 30°C ± 2°C/65% RH ± 5% RH 12 months Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months If at any time during 6 months‘ testing under the accelerated storage condition, such changes occur that cause the product to fail in complying with the prescribed standards, additional testing under an intermediate storage condition should be conducted and evaluated against significant change criteria. (ii) Study conditions for drug substances and formulations intended to be stored in a refrigerator Study Study conditions Duration of study Long term 5°C ± 3°C 12 months Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months (iii) Study conditions for drug substances and formulations intended to be stored in a freezer Study Study conditions Duration of study____________________ Long term - 20°C ± 5°C 12 months (iv) Drug substances intended for storage below -20°C shall be treated on a case-by- case basis. (v) Stability testing of the formulation after constitution or dilution, if applicable, should be conducted to provide information for the labelling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period. APPENDIX X CONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL TRIALS