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

15(ii) Evaluation of the effect of food on absorption following oral administration should be carriedout. Data from dissolution studies should also be submitted for all solid oral dosage forms.(iii) Dissolution and bioavailability data submitted with the new drug application must provideinformation that assures bioequivalence or establishes bioavailability and dosage correlationsbetween the formulation(s) sought to be marketed and those usedfor clinical trials during clinical development of the product. (See items 8.1, 8.2 and 8.3 ofAppendix I,).(iv) All bioavailability and bioequivalence studies should be conducted according to theGuidelines for Bioavailability and Bioequivance studies as prescribed.Note.- The data requirements stated in this Schedule are expected to provideadequate information to evaluate the efficacy, safety and therapeutic rationale of newdrugs (as defined under rule 122-E) prior to the permission for sale. Depending uponthe nature of new drugs and disease(s), additional information may be required by theLicensing Authority. The applicant shall certify the authencity of the data anddocuments submitted in support of an application for new drug. The LicensingAuthority reserves the right to reject any data or any document(s) if such data orcontents of such documents are found to be of doubtful integrity.APPENDIX IDATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO CONDUCTCLINICAL TRIALS / IMPORT / MANUFACTURE OF NEW DRUGS FOR MARKETINGIN THE COUNTRY.1. 1. IntroductionA brief description of the drug and the therapeutic class to which it belongs.