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Compliance Requirements under the Rules

1. Form CT-11: Permission to manufacture new drugs or investigational new drugs (Rule 53 (1), (2), (2A))

Rule 52: No person shall manufacture a new or investigational new drug for clinical trials, bioavailability/bioequivalence studies, or related tests without permission from the Central Licensing Authority. An application in Form CT-10, along with required documents (Fourth Schedule) and fee (Sixth Schedule), must be submitted for approval.

Central Licensing Authority shall review Form CT-10 applications and, within 90 working days, may grant permission in Form CT-11, seek request rectification of deficiencies, or reject the application with reasons. If no response is given within 90 days, approval is deemed granted and legally valid.

2. Rectification, Reconsideration, and Appeal Process for Clinical Trial and New Drug Applications (Rule 53 (3), (4))

Applicant may rectify deficiencies and resubmit; Authority will review and decide within 90 days. If rejected, a request for reconsideration may be made within 60 working days with required fee and documents. Appeals can be filed within 45 days and resolved in 60 working days.

Rule 54:

(1) The permission granted under rule 53 in Form CT-11 shall remain valid for a period of three years from the date of its issue, unless suspended or cancelled by the Central Licencing Authority.

(2) In exceptional circumstances, where the Central Licencing Authority is satisfied about the necessity and exigency, it may, on the request of the applicant made in writing, by order, and for reasons to be recorded, extend the period of the permission granted for a further period of one year

3. Conditions of permission for manufacturing of New Drugs or Investigational New Drugs (Rule 55)

Permission under Form CT-11 is subject to the following:

(i) The drug shall only be used for clinical trials, bioavailability/bioequivalence studies, or related tests and no part of it shall be sold in the market or supplied to any other person or agency or institution or organisation.

(ii) Manufacture must be in small quantities, at approved sites, and follow Good Manufacturing Practices.

(iii) Records must be maintained of drugs manufactured and supplied.

(iv) Unused, expired, damaged, or substandard drugs must be destroyed, with proper documentation.

4. Appeal in case of suspension or cancellation of manufacturing permission (Rule 58)

Subject to provisions of rule 55, where the permission holder, fails to comply with any provision of the Act and these rules, the Central Licencing Authority may, after giving that person an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one or more of the following actions, namely:-

(i) suspend the permission for such period as considered appropriate; (ii) cancel the permission granted under rule 53 in Form CT-11.

(2) Where the permission holder whose permission has been suspended or cancelled is aggrieved by an order of the Central Licencing Authority, he may, within sixty days of the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording an opportunity of being heard, pass such order in relation thereto as may be considered appropriate in the facts and circumstances of the case.

5. Form CT-14 & CT-15: Permission to manufacture unapproved API for development of formulation/Test or Analysis (Rule 60 (1), (2))

The Central Licensing Authority shall, within 90 working days, grant permission in Form CT-14 or CT-15 if requirements are met, or reject the application with reasons, or inform of deficiencies. If no response is received, permission is deemed granted and legally valid.

If a manufacturer of a pharmaceutical formulation intends to procure an unapproved active pharmaceutical ingredient (under rule 76 or 81) for development and to manufacture batches for testing, clinical trials, or bioavailability and bioequivalence study, the formulation manufacturer must apply in Form CT-12 and the active pharmaceutical ingredient manufacturer in Form CT-13, each with required documents as specified.

6. Intimation and Record of Deemed Approval Prior to Manufacturing (Rule 60 (2A))

Applicant who has got deemed approval under the proviso to sub-rule(1) shall, before manufacturing unapproved active pharmaceutical ingredient or its pharmaceutical formulation for the said purposes inform the Central Licensing Authority in Form CT-15A and CT-14A respectively and the Central Licensing Authority shall on the basis of the said information, take on record the Form CT-15A and CT-14A which shall become part of the official record and shall be called deemed approval of the Central Licensing Authority.

7. Procedure for Filing an Appeal to the Central Government (Rule 60 (3))

An applicant who is aggrieved by the decision of the Central Licencing Authority may file an appeal before the Central Government within sixty days from the date of receipt of such rejection and that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty days from the date of filing the appeal.

8. Appeal in case of suspension or cancellation of permission to manufacture unapproved API (Rule 62)

(1) Subject to provision of rule 60, where the formulation manufacturer or an active pharmaceutical ingredient manufacturer fails to comply with any provisions of the Act and these rules, the Central Licencing Authority may, after giving an opportunity to show cause and after affording an opportunity of being heard, by an order in writing, take one or more of the following actions, namely:-

(i) suspend the permission for such period as considered appropriate;

(ii) cancel the permission granted under rule 60 in Form CT-14 or Form CT-15.

(2) Where the formulation manufacturer or active pharmaceutical ingredient manufacturer whose permission has been suspended or cancelled under sub-rule (1), is aggrieved by an order of the Central Licencing Authority, such manufacturer may, within forty-five days of the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording an opportunity of being heard, pass such orders in relation thereto as may be considered appropriate in the facts and circumstances of the case.

9. Conditions of permission for manufacture unapproved API for development of formulation (Rule 63)

Permission under Rule 60 (Form CT-14/15) is subject to the following conditions:

(i) the unapproved API must be used strictly for the purposes specified in the permission and must not be sold;

(ii) manufacturing must comply with the rules and, if for clinical trial or bioavailability and bioequivalence study, follow Good Manufacturing Practices at approved locations;

(iii) the manufacturer must maintain complete records of the quantity of drug procured, manufactured, used, disposed of, and related activities;

(iv) any leftover, expired, damaged, or substandard active pharmaceutical ingredient or formulation must be destroyed, and the action taken must be properly documented.

10. Labelling Requirements for manufacture of New Drugs and Investigational New Drugs (Rule 66)

(1) Any new drug or investigational new drug manufactured, for the purpose of clinical trial or bioavailability or bioequivalence study, shall be kept in containers bearing labels, indicating the name of drug or code number, batch or lot number, wherever applicable, date of manufacture, use before date, storage conditions, name of the institution or organisation where the clinical trial or bioavailability or bioequivalence study is proposed to be conducted, name & address of the manufacturer, and the purpose for which it has been manufactured.

(2) If a new or investigational drug is made by the permission holder for another party, the label must include the names and addresses of both the manufacturer and recipient, the scientific name (if known) or identifying reference, and the purpose of manufacture.

(3) No person or manufacturer may alter, remove, or deface any label, mark, or inscription on a new drug’s container or packaging without approval from the Central Licensing Authority.

11. Form CT-16: Application For Grant Of Licence To Import New Drug Or Investigational New Drug (Rule 67)

(1) No person shall import a new drug or any substance relating thereto for conducting clinical trial or bioavailability or bioequivalence study or for examination, test and analysis except in accordance with the licence granted by Central Licencing Authority.

(2) Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or bioavailability or bioequivalence study or for examination, test and analysis shall make an application in Form CT-16 to the Central Licencing Authority.

(3) The application shall be accompanied by a fees specified in the Sixth Schedule and such other information and documents as specified in Form CT-16.

12. Form CT-17: Licence To Import New Drug Or Investigational New Drug (Rule 68 (1), (2))

Rule 67: Import of a new drug or related substance for clinical trials, bioavailability or bioequivalence study, or tests requires a licence from the Central Licensing Authority. Applicants must submit Form CT-16 with the prescribed fee (Sixth Schedule) and required documents as specified in the form.

The Central Licensing Authority shall review Form CT-16 and may grant an import licence in Form CT-17 within 90 days if all requirements are met. If there are deficiencies, the applicant will be informed. If not satisfied, the application will be rejected with written reasons.

13. Appeal Process Against Central Licensing Authority’s Decision in case of import of new drug (Rule 68 (3))

An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1) or sub-rule (2), may file an appeal before the Central Government within sixty days from the date of receipt of such rejection and that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days.

14. Condition of licence for import of new drug or investigational new drug (Rule 70)

The licence granted under rule 68 in Form CT-17 is subject to the following conditions, namely:

(i) it shall be the responsibility of the licence to ensure that the new drug has been manufactured in accordance with the provisions of the Act, these rules and principles of Good Manufacturing Practices;

(ii) the licensee shall use the imported new drug solely for clinical trials, bioavailability or bioequivalence studies, or tests, and shall not sell or supply it to any person, agency, or organization.;

(iii) the licensee shall maintain records of imported new drug or substance relating thereto to indicate the quantity of drug imported, used, disposed of in any manner and other matters related thereto;

(iv) where the imported new drug or substance relating thereto is left over or remains unused or gets damaged or its specified shelf life has expired or has been found to be of sub-standard quality, the same shall be destroyed and details of action taken in such cases shall be recorded.

15. Appeal when Suspension or cancellation of import licence of new drug (Rule 72)

If the licensee fails to comply with any provisions of the Act or rules, the Central Licensing Authority, after giving the licensee an opportunity to show cause and be heard, may suspend or cancel the license, either entirely or partially concerning specific substances involved in the violation. The Authority may also order the disposal of the imported new drugs in a manner it deems appropriate, as specified in the written order.

If the licensee is aggrieved by the suspension or cancellation order, they may appeal to the Central Government within 45 days of receiving the order. Upon receiving the appeal, the Central Government will conduct an enquiry, allow the licensee an opportunity to be heard, and issue a decision within 60 working days from the appeal filing date. The Government’s decision will be considered final, and any further actions or orders will be based on the findings of the enquiry.

16. Labelling Requirements for Import of New Drugs and Investigational New Drugs (Rule 73)

(1) Any new or investigational drug imported for clinical trial or bioavailability or bioequivalence study must be stored in containers labelled with the drug name or code, batch or lot number (if applicable), manufacturing date, expiry date, storage conditions, name of trial site or institution, manufacturer’s name and address, and the purpose of import.

(2) If a new or investigational drug is imported on behalf of another person, the licensee must label the container with the importer’s name and address, the recipient’s details, the drug’s scientific name (if known) or identifiable reference, and its intended purpose.

(3) No person or importer shall alter, obliterate or deface any inscription or mark made on the container, label or wrapper of any new drug imported without permission of the Central Licencing Authority.

17. Form CT-19: Permission To Import New Active Pharmaceutical Ingredient For Sale Or For Distribution (Rule 76 (1), (2))

Rule 75: Any person who intends to import new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or for distribution in India, shall make an application to obtain a permission from the Central Licencing Authority in Form CT-18 along with a fee as specified in the Sixth Schedule. If an application for grant of permission to import a new drug, in the form of active pharmaceutical ingredient which is a new drug not approved earlier, shall be accompanied by an application for grant of permission to manufacture pharmaceutical formulation of that new drug

The Central Licensing Authority shall review Form CT-18 and grant or reject permission in Form CT-19 within 90 working days. Deficiencies, if any, must be rectified within the specified time. Reconsideration of a rejected application is allowed within 60 days with fee and documents.

18. Appeal Process Against Decision of Central Licensing Authority when Import new drugs (Rule 76 (3))

An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1) and sub-rule (2), may file an appeal before the Central Government within sixty days from the date of receipt of such rejection and that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days from the date of filing the appeal.

19. Condition of permission for import of new drugs for sale or distribution (Rule 77)

Import of new drugs under Rule 76 is subject to:

(i) Compliance with Central Licensing Authority specifications.

(ii) Labelling as per Drugs and Cosmetics Rules, 1945.

(iii) A warning on the label: “WARNING: To be sold by retail on the prescription of a……………only.

(iv) as post marketing surveillance, the applicant shall submit Periodic Safety Update Reports as specified in the Fifth Schedule;

(v) all reported adverse reactions related to drug shall be intimated to the Central Licencing Authority and regulatory action resulting from their review shall be complied with;

(vi) no claims except those mentioned above shall be made for the drug without prior approval of the Central Licencing Authority;

(vii) specimen of the carton, labels, package insert that will be adopted for marketing the drug in the country shall be got approved from the Central Licencing Authority before the drugs is marketed;

(viii) in case of import, each consignment shall be accompanied by a test or analysis report;

(ix) if long-term stability data submitted do not cover the proposed shelf-life of the product, the stability study shall be continued to firmly establish the shelf-life and the complete stability data shall be submitted.

20. Appeal when Suspension or cancellation of import permission for new drug (Rule 78)

(1) Where the importer fails to comply with any provision of the Act and these Rules, the Central Licencing Authority may, after giving show cause notice and an opportunity of being heard, by an order in writing, may suspend the permission for such period as considered appropriate or cancel the permission.

(2) Where the importer whose permission has been suspended or cancelled under sub-rule (1), is aggrieved by an order of the Central Licencing Authority, such importer may, within forty-five days of the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after giving an opportunity of being heard, pass such order as may be considered appropriate in the facts and circumstances of the case.

21. Form CT-22: Permission To Manufacture New API For Sale Or For Distribution (Rule 81 (1), (2))

Rule 80: (1) A person who intends to manufacture new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licencing Authority in Form CT-21 along with a fee as specified in the Sixth Schedule. If that no fee shall be required to be paid along with the application for manufacture of a new drug based on successful completion of clinical trials from Phase I to Phase III under these Rules in India, where fee has already been paid by the same applicant for conduct of such clinical trials. If an application for grant of permission to manufacture a new drug for sale or distribution in the form of active pharmaceutical ingredient having a new drug molecule not approved earlier shall be accompanied by an application for grant of permission to manufacture for sale or distribution of pharmaceutical formulation of the said new drug

On receiving Form CT-21, the Central Licensing Authority shall grant or reject permission to manufacture new drugs in Form CT-22 within 90 working days. Deficiencies, if any, must be rectified within the specified time. Rejected applications may be reconsidered within 60 days with fee and documents.

22. Form CT-22: Permission To Manufacture New Pharmaceutical Formulation For Sale Or For Distribution (Rule 81 (1), (2))

Rule 80: (1) A person who intends to manufacture new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, for sale or distribution, shall make an application for grant of permission to the Central Licencing Authority in Form CT-21 along with a fee as specified in the Sixth Schedule. If that no fee shall be required to be paid along with the application for manufacture of a new drug based on successful completion of clinical trials from Phase I to Phase III under these Rules in India, where fee has already been paid by the same applicant for conduct of such clinical trials. If an application for grant of permission to manufacture a new drug for sale or distribution in the form of active pharmaceutical ingredient having a new drug molecule not approved earlier shall be accompanied by an application for grant of permission to manufacture for sale or distribution of pharmaceutical formulation of the said new drug

On receiving Form CT-21, the Central Licensing Authority shall grant or reject permission to manufacture new drugs in Form CT-23 within 90 working days. Deficiencies, if any, must be rectified within the specified time. Rejected applications may be reconsidered within 60 days with fee and documents.

23. Appeal Process Against Decision of Central Licensing Authority when Manufacture new drugs (Rule 81 (3))

An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1) or sub-rule (2), may file an appeal before the Central Government within sixty days from the date of receipt of such rejection and that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days from the date of filing the appeal.

24. Condition of permission for manufacture of new drugs for sale or distribution (Rule 82)

Permission granted in Form CT-22 or CT-23 (Rule 81) is subject to:

(i) Compliance with Central Licensing Authority specifications.

(ii) Labelling as per the Drugs & Cosmetics Rules, 1945.

(iii) Warning on the label: “WARNING: To be sold by retail on the prescription of a…Only” in a red-background box.

(iv) as post marketing surveillance, the applicant shall submit Periodic Safety Update Reports as specified in the Fifth Schedule;

(v) all reported serious unexpected adverse reactions related to the drug shall be intimated to the Central Licencing Authority and regulatory action resulting from their review shall be complied with;

(vi) no claims except those mentioned above shall be made for the drug without prior approval of the Central Licencing Authority;

(vii) specimen of the carton, labels, package insert that will be adopted for marketing the drug in the country shall be got approved from the Central Licencing Authority before the drugs is marketed;

(viii) if long-term stability data submitted do not cover the proposed shelf-life of the product, the stability study shall be continued to firmly establish the shelf-life and the complete stability data shall be submitted.

25. Appeal when Suspension or cancellation of manufacture permission for new drug for sale or dist. (Rule 84)

(1) Where the manufacturer fails to comply with any provisions of the Act, these rules and any condition of the permission, the Central Licencing Authority may, after affording an opportunity of being heard, suspend or cancel the permission for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates.

(2) Where the manufacturer whose permission has been suspended or cancelled under sub-rule (1) is aggrieved by an order of the Central Licencing Authority, such manufacturer may, within thirty days of the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording an opportunity of being heard, pass such orders in relation thereto as considered appropriate.

26. Responsibility of importers or manufacturers in marketing of new drugs (Rule 85)

The manufacturer or importer of new drugs shall be responsible for marketing a new drug for the approved indication and in only such dosage form for which it has been permitted. If the manufacturer or importer of new drug shall not be punished for the consequences resulting from use of the drug for an indication other than for which the drug has been approved where the manufacturer proves that he has not been involved in any manner in the promotion of use of the new drug for other than approved indication.

27. Form CT-25: License To Import Unapproved New Drug For Treatment of Patients (Rule 87 (1), (3))

Rule 86: A medical officer of a Government hospital or institution may apply in Form CT-24 to import a new drug not approved in India but approved in its country of origin for treating life-threatening or serious diseases. The application must be certified and include required documents and fee.

The CLA may grant or reject a licence in Form CT-25 for import of an unapproved new drug by a Government hospital/institution within 90 days. Import is limited to 100 doses per patient, but higher quantities may be allowed in exceptional cases based on patient need.

28. Appeal Against Rejection of Licence for Import of Unapproved New Drug (Rule 87 (2))

An applicant who is aggrieved by the decision of the Central Licencing Authority under sub-rule (1), may file an appeal before the Central Government within forty-five days from the date of receipt of such rejection and that Government, may, after such enquiry, and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of sixty working days from the date of filing the appeal.

29. Conditions of licence (Rule 88)

The import licence granted under rule 87 in Form CT-25 shall be subject to the following conditions, namely:-

(i) the licence must be displayed at the medical institution, including areas where the unapproved new drug is stored and in the office of the Medical Superintendent or Head of the institution.;

(ii) the licensee shall stock the unapproved new drug imported under this licence under proper storage conditions;

(iii) the unapproved new drug shall be used only for the specified patient under a registered pharmacist’s supervision and must not be sold or supplied to any other person, agency, institution, or place.;

(iv) the registered pharmacist shall maintain records as per the Annexure of Form CT-25, countersigned by the Medical Superintendent or Head of the institution, and produce them on demand to an officer authorized by the Central Licensing Authority;

For all other applicable conditions, refer to Rule 88 of the New Drugs and Clinical Trials Rules, 2019.

30. Appeal when Suspension or cancellation of import licence for unapproved new drug (Rule 89)

(1) Where any licensee, fails to comply with any provision of the Act and these rules, the Central Licencing Authority, may after affording an opportunity of being heard, by an order in writing, suspend or cancel the permission for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates.

(2) Where the licensee, whose licence has been suspended or cancelled under sub-rule (1) is aggrieved by an order of the Central Licencing Authority, he may, within a period of forty-five days from the receipt of the order, make an appeal to the Central Government and that Government may, after such enquiry, as deemed necessary and after affording an opportunity of being heard, pass such orders in relation thereto as considered appropriate.

31. Form CT-27: Permission To Manufacture Unapproved New Drug But Under Clinical Trial (Rule 92)

Rule 91: In special cases, a manufacturer may seek Central Licencing Authority permission in Form CT-26 to produce an unapproved new drug under clinical trial, based on a medical officer’s prescription, patient consent, and Ethics Committee recommendation

The Central Licencing Authority may grant or reject permission in Form CT-27 within 90 days for manufacturing an unapproved new drug under clinical trial for serious or life-threatening conditions. Quantity is limited to 100 doses per patient, extendable in exceptional cases with due approvals.

32. Condition of permission (Rule 93)

The permission granted under rule 92 in Form CT-27, is subject to the following conditions, namely :-

(i) the patient shall use the unapproved new drug under medical officer supervision at the approved location or any other site authorised by the Central Licensing Authority;

(ii) the manufacturer to whom the permission is granted, shall use the unapproved new drug solely for the permitted purpose; sale or supply to any other person, agency, institution, or place is strictly prohibited;

(iii) the manufacturer shall keep record of the unapproved new drugs manufactured, stored and supplied by him to the patient in a register in the format as specified in annexure of Form CT-27;

(iv) the manufacturer, shall submit to the Central Licencing Authority a half yearly report about the status of the unapproved new drugs manufactured, supplied to the authorised patient;

For all other applicable conditions, refer to Rule 93 of the New Drugs and Clinical Trials Rules, 2019.

33. Appeal when Suspension or cancellation of permission to manufacture unapproved new drug (Rule 95)

(1) Where the manufacturer to whom permission is granted under rule 92 fails to comply with any provision of the Act and these rules, the Central Licencing Authority, may, after giving an opportunity of being heard, by an order, in writing, suspend or cancel the permission for such period as considered appropriate either wholly or in respect of some of the substances to which the violation relates.

(2) Where the manufacturer whose permission is suspended or cancelled under sub-rule (1) is aggrieved by an order of the Central Licencing Authority, he may, within a period of forty-five days from the receipt of the order, make an appeal to the Central Government in respect of suspension or cancellation of the permission and that Government, may, after such enquiry, as deemed necessary and after affording an opportunity of being heard, pass such orders in relation thereto as considered appropriate.