3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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56should be submitted. If the FDC is marketed abroad, the regulatory status in othercountries should be stated. (see Appendix I, item 9).(ii) For marketing permission, appropriate chemical and pharmaceutical data will besubmitted. In case such a combination is not marketed anywhere in the world butthese drugs are already in use concomitantly (not as an FDC but individually) for thesaid claim, marketing permission may be granted based on chemical andpharmaceutical data. Data showing the stability of the proposed dosage form will alsohave to be submitted.(iii) For any other such FDCs, clinical trials may be required. For obtainingpermission to carry out clinical trials with such FDCs a summary of availablepharmacological, toxicological and clinical data on the individual ingredients shouldbe submitted, along with the rationale for combining them in the proposed ratio. Inaddition, acute toxicity data (LD 50) and pharmacological data should be submitted onthe individual ingredients as well as their combination in the proposed ratio.(c)The third group of FDCs includes those which are already marketed, but in which it isproposed either to change the ratio of active ingredients or to make a new therapeuticclaim. For such FDCs, the appropriate rationale including published reports (if any)should be submitted to obtain marketing permission. Permission will be granteddepending upon the nature of the claim and data submitted.(d)The fourth group of FDC includes those whose individual active ingredients (or drugsfrom the same class) have been widely used in a particular indication(s) for years,their concomitant use is often necessary and no claim is proposed to be made otherthan convenience. It will have to be demonstrated that the proposed dosage form isstable and the ingredients are unlikely to have significant interaction of apharmacodynamic or pharmacokinetic nature.No additional animal or human data are generally required for these FDCs, andmarketing permission may be granted if the FDC has an acceptable rationale.
57Appendix VIIUNDERTAKING BY THE INVESTIGATOR1. Full name, address and title of the Principal Investigator (or Investigator(s)when there is no Principal Investigator)2. Name and address of the medical college, hospital or other facility where theclinical trial will be conducted: Education, training & experience that qualifythe Investigator for the clinical trial (Attach details including Medical Councilregistration number, and / or any other statement(s) of qualification(s))3. Name and address of all clinical laboratory facilities to be used in the study.4. Name and address of the Ethics Committee that is responsible for approval andcontinuing review of the study.5. 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 (s).6. Protocol Title and Study number (if any) of the clinical trial to be conducted bythe Investigator.7. Commitments:(i) I have reviewed the clinical protocol and agree that it contains all thenecessary information to conduct the study. I will not begin the study until allnecessary Ethics Committee and regulatory approvals have been obtained.(ii) I agree to conduct the study in accordance with the current protocol. I willnot implement any deviation from or changes of the protocol without
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42. CLINICAL TRIAL(1) Approval for
Page 7 and 8: 7(5) Responsibilities of the Ethics
Page 9 and 10: 9study and to determine the common
Page 11 and 12: 11(1) Geriatrics.-Geriatric patient
Page 13 and 14: 13(viii)For clinical trials conduct
Page 15 and 16: 15(ii) Evaluation of the effect of
Page 17 and 18: 172.6. 2.6. Stability Studies (for
Page 19 and 20: 198.2. 8.2. Bio-availability / Bio-
Page 21 and 22: 21brief description of the trial de
Page 23 and 24: 2315. List of References16. Appendi
Page 25 and 26: 25whichever is higher) is recommend
Page 27 and 28: 27hours. Animals should be observed
Page 29 and 30: 29showing minimal toxicity in syste
Page 31 and 32: 31One male and one female from each
Page 33 and 34: 33taken. Formulation in volume comp
Page 35 and 36: 35the same route in a batch of 4 ma
Page 37 and 38: 37(i) (i) In-vitro exposure (with a
Page 39 and 40: 39At least three dose levels should
Page 41 and 42: 41Female Reproduction and Developme
Page 43 and 44: 43Reaction(pH)• • Bilepigments
Page 45 and 46: 45Allergenicity/Hypersensitivity te
Page 47 and 48: 47Specific and general pharmacologi
Page 49 and 50: 49These include ventricular contrac
Page 51 and 52: 511.6 Application Of Good Laborator
Page 53 and 54: 5313. Statement that participation
Page 55: 55Signatory’s Name: _____________
Page 59 and 60: 59(ix) I agree to promptly report t
Page 61 and 62: 612. Format for Approval of Ethics
Page 63 and 64: 63Appendix IXSTABILITY TESTING OF N
Page 65 and 66: 65(i) Study conditions for drug sub
Page 67 and 68: 67Previous clinical work with the n
Page 69 and 70: 69d. Possible drug interactionse. C
Page 71 and 72: 71Appendix XIData Elements for repo
Page 73: 73(F.No. X-11014/1/2003-DMS & PFA)(
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3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

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