ule 122-E of the Drugs and Cosmetics Rules consider new drugs as drug. Rule 122-E also includes bulk drug substances or phytopharmaceutical drugs which means any drug that has not been used significantly and the same drug has been considered ineffective by the licensing authority (under Rule 21). Apart from these, derived drugs like vaccines and Recombinant DNA (r-DNA) and drugs with certain modifications such as dosage, indication and route of administration approved by licensing authority to be marketed are taken as drugs as per rule 21. A drug will be considered a new drug for 4 years from the date it is approved.
The effectiveness of a drug is necessary to check before it is marketed to ensure that the drug is safe for human use. The following rules govern the clinical trial of new drugs:
Rules Description 122-A Application to permit the import of new drug 122-B Application to approve manufacture of new drugs 122-DA Contains condition to get permission from DCG (I) to conduct a clinical trial of a new drug 122 DAB Guidelines to examine serious adverse event (SAE) and compensation in case of injury and death and other related trial cases. Rule 122 DAC Guidelines to follow Good Clinical Practices (GCP) and debarment of an applicant for not following the rules. Rule 122 E Contains the definition of new drugs Schedule Y Instructions to follow and requirements needed to conduct clinical trials and approval of new drugs
Role of New Drug Approval Division
- The department processes the application for New drugs. The application is reviewed in accordance with Schedule Y, Rule 122 A, 122 B, 122 DA, 122 DAB, 122 DAC and 122 E under Drugs & Cosmetics Rules 1945. - The department is given the duty to check the application thoroughly for clinical trials and Academic Clinical Trials (as per GSR 313 E dated 16th March 2016). - It reviews and deal with RTI and parliament questions. - Evaluation of (ICD), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Reports (DSUR), Change in Principal Investigator, Information Brochure (IB),Clinical Trial Agreements, Ethics committee approval of PI sites, etc. - It monitors the safety of medical products that have been approved for marketing purposes on the basis of documents like PSURs, SAE reports, complaints received etc. - The department also deals with the application to update the prescribing data. - It is also responsible to process Signal Review Panel (PvPI-NCC, IPC) recommendations for vital Regulatory Action.
The DCG(I) approves the application for a drug product or drug substance. The following processes are followed to approve drugs: - The applicant submits the application with the required fees. - The application then goes to preliminary evaluation. If any discrepancy is found the applicant is informed to resolve the issue. In case, no discrepancy is found the application is forwarded for Regulatory evaluation. - If the application is for CT (Clinical Trial) or BE (Bioequivalence) permission is granted and then the application is reviewed by the Subject Expert Committee (SEC). The application goes for NOC (No Objection Certificate), the report is reviewed and if the data is satisfactory, the site facility is inspected (if required) before the final approval. - But if the application is not for BE and CT, the application goes for review of CMC (Chemistry & Manufacturing Control) data and then forwarded for IPC testing and NOC (No Objection Certificate) is provided. IPC Test Report must comply before it goes for final approval. Before the application goes for final approval, if required, the site facility is inspected.
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