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

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10(iii) For new drugs approved outside India, Phase III studies need to be carried out primarilyto generate evidence of efficacy and safety of the drug in Indian patients when used asrecommended in the prescribing information. Prior to conduct of Phase III studies in Indiansubjects, Licensing Authority may require pharmacokinetic studies to be undertaken to verifythat the data generated in Indian population is in conformity with the data already generatedabroad.(iv) If the application is for the conduct of clinical trials as a part of multi-national clinicaldevelopment of the drug, the number of sites and patients as well as the justification forundertaking such trials in India should be provided to the Licensing Authority along with theapplication.(9) Post Marketing Trials (Phase IV).- Post Marketing trials are studies (otherthan routine surveillance) performed after drug approval and related to theapproved indication(s). These trials go beyond the prior demonstration of thedrug’s safety, efficacy and dose definition. These trials may not be considerednecessary at the time of new drug approval but may be required by theLicensing Authority for optimizing the drug's use. They may be of any type butshould have valid scientific objectives. Phase IV trials include additional drugdruginteraction(s), dose-response or safety studies and trials designed tosupport use under the approved indication(s), e.g. mortality/morbidity studies,epidemiological studies etc.3. Studies in special populations:Information supporting the use of the drug in children, pregnant women, nursingwomen, elderly patients, patients with renal or other organ systems failure, and those onspecific concomitant medication is required to be submitted if relevant to the clinical profile ofthe drug and its anticipated usage pattern. Any claim sought to be made for the drug productthat is not based on data submitted under preceding items of this Schedule should be supportedby studies included under this item of the Schedule (Appendix I, item 8.3).
11(1) Geriatrics.-Geriatric patients should be included in Phase III clinical trials (and inPhase II trials, at the Sponsor's option) in meaningful numbers, if-(a) (a) the disease intended to be treated is characteristically a disease ofaging; or(b) (b) the population to be treated is known to include substantial numbersof geriatric patients; or(c) (c) when there is specific reason to expect that conditions common inthe elderly are likely to be encountered; or(d) (d) when the new drug is likely to alter the geriatric patient's response(with regard to safety or efficacy) compared with that of the nongeriatricpatient.(2) Paediatrics.-(i) The timing of paediatric studies in the new drug development program will depend on themedicinal product, the type of disease being treated, safety considerations, and the efficacyand safety of available treatments. For a drug expected to be used in children, evaluationsshould be made in the appropriate age group. When clinical development is to include studiesin children, it is usually appropriate to begin with older children before extending the trial toyounger children and then infants.(ii) If the new drug is for diseases predominantly or exclusively affecting paediatricpatients, clinical trial data should be generated in the paediatric population except forinitial safety and tolerability data, which will usually be obtained in adults unless suchinitial safety studies in adults would yield little useful information or expose them toinappropriate risk.(iii) If the new drug is intended to treat serious or life-threatening diseases, occurringin both adults and paediatric patients, for which there are currently no or limitedtherapeutic options, paediatric population should be included in the clinical trials early,following assessment of initial safety data and reasonable evidence of potentialbenefit. In circumstances where this is not possible, lack of data should be justified indetail.
Page 4 and 5: 42. CLINICAL TRIAL(1) Approval for
Page 7 and 8: 7(5) Responsibilities of the Ethics
Page 9: 9study and to determine the common
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
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Page 53 and 54: 5313. Statement that participation
Page 55 and 56: 55Signatory’s Name: _____________
Page 57 and 58: 57Appendix VIIUNDERTAKING BY THE IN
Page 59 and 60: 59(ix) I agree to promptly report t
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612. Format for Approval of Ethics
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63Appendix IXSTABILITY TESTING OF N
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65(i) Study conditions for drug sub
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67Previous clinical work with the n
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69d. Possible drug interactionse. C
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71Appendix XIData Elements for repo
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73(F.No. X-11014/1/2003-DMS & PFA)(
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