By Team Metacorp on 29 Sep 2022
How to get CDSCO NOC for new drug manufacturing?
About New Drugs
Rule 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:
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.
New Drugs Approval Procedure
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.
Documents Required for Approval of New Drugs
Applicants must submit the following documents for the import or manufacturing of new drugs.
1. The purpose of the application must be clearly stated.
2. Mention the name of the applicant and the name of the drug along with composition, dosage and indication for the proposed drug.
3. Signature and stamp of authorized person in Form 44.
4. Challan (INR 50,000 for phase I and INR 25,000 for phase II/III).
5. Copy of manufacturing license.
6. Bulk drug source
7. Information regarding Chemical and Pharmaceutical.
8. Information with respect to active ingredients of the drug (generic name, chemical name or INN). Also, provide Physiochemical data, Analytical data, monograph specifications, validations, stabilities studies and formulation data.
9. Submit Animal Pharmacology, Animal Toxicology data.
10. Submission of report and study of Human / Clinical pharmacology (Phase I)
11. Summary and report of Therapeutic exploratory trials (Phase II).
12. Summary and report along with a list of sites and investigators of Therapeutic confirmatory trials (Phase III).
13. Summary of BA/BE and other special studies such as paediatrics, geriatrics, pregnant or nursing women.
14. Regulatory status of a new drug in other countries where it has been approved and marketed. This also includes restrictions on the use of a new drug in other countries where it has been approved and marketed.
15. Information with respect to the package which contains details like generic name, composition, shelf-life, and other vital details.
16. Submit samples and Testing Protocols of the proposed drug.
17. Submission of draft of label and cartoon of the proposed drug as per Rules 96 and 97.
18. It is to note that if the aim of the study drug is to be imported to examine or conduct tests, then the application should be made in Form - 12.
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