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FAQ's for New Drug Regulations
Frequently Asked Questions --- NEW DRUG REGULATIONS
Q1. What is a New Drugs in India?
Ans: New Drug is defined under Rule 122 E : For the purpose of this Part, new drug shall mean and include-
(a) A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.
(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of 3[Appendix VI] to Schedule Y.)
Explanation.- For the purpose of this rule−
(i) All vaccines shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;
(ii) A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.
Q2. Whether new drugs are regulated in India?
Ans: Yes, import, manufacture, sale and distribution of new drugs and Clinical Trials are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.and requirements under Schedule-Y.
Q3. Where can we get a copy of the Drugs & Cosmetic Act 1940 & Rules 1945?
Ans: The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 is available in Link:http://cdsco.nic.in
Q4. Whether New Drugs includes Biotech drugs, r-DNA derived drugs, and Vaccines, Biologicals and FDCs are regulated in India?
Ans: Yes, as per rule 122 E and amendments made in from time to time under the Drugs and Cosmetics Act, and Rules thereunder.
Q5. Which is the Regulatory Authority that governs the regulations of Import of new drugs in India?
Ans: Drugs Controller General (India), Central Drugs Standard Control Organization(CDSCO), Directorate General of Health Services , Ministry of Health and Family Welfare, Government of India , FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Phone: 91-11- 23236965 / 23236975, Fax: 91-11-23236973, E-mail:- email@example.com
Q6. Which division of CDSCO (HQ) is responsible for registration/import of New drugs in India?
Ans: New Drug, Biological / Vaccine Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002 is responsible for registration/import of New Drugs in India.
Q7. What are the requirements for Manufacture and Market of New Drugs in India?
Ans: An Application in Form 44 under rule 122 B along with Fee Challan of Rs. 50,000 and Dossier as per Schedule –Y of Drugs & Cosmetics Rule.
Q8. What are the requirements for import of New Drugs in India?
Ans: After the approval in Form 45 under rule 122 A, For the import of new drugs in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of new drugs, the manufacturing site and products (new drugs) are required to be registered with Indian drug regulatory agency (i.e. Central Drugs Standards Control Organization).
Q9. Whether Registration is required for import of New Drugs for Testing / Clinical Trial purpose in India?
Ans: No, registration is not required for import of New Drugs for Testing / Clinical Trial purpose in India. However, the NOC / Test –License in Form 11 is mandatory.
Q10. Who can import New Drugs into India?
Ans: Any person / Hospital based on doctor’s prescription can import new drugs under personal License (11A/ 11B) issued under Drugs and Cosmetics Act, 1940 and Rules 1945.
Q11. To whom shall the application be submitted for Registration/Import License for New Drugs in India?
Ans. Applications for Registration/ Import License of New Drugs shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 /23236975. Fax: 91-11-23236973, as per Drugs & Cosmetics Rules in India.
12. What is the procedure to apply for the "Registration certificate" in Form-41 for New Drugs in India?
Ans: Following steps may be adopted for Registration application
STEP 1.Pay the required Registration fee through TR-6 Challan (in triplicate) in Bank of Baroda, Kasturba Gandhi Marg, New Delhi.
A fee of one thousand and five hundred US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for the manufacturing premises meant for manufacturing of New Drugs intended for import into and use in India.
A fee of one thousand US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a new drug meant for import into and use in India
STEP 2.Compilation of Registration dossier as per the guidance documents available at the link: http://cdsco.nic.in
STEP 3.Submit Product Registration application at CDSCO (HQ), New Delhi
Q13. Whether New Drug manufacturing site required to be inspected before grant of Registration Certificate in Form 41? If yes, how much fees for the inspection or visit of the manufacturing premises of New Drugs ?
Ans: No, however if required the applicant shall be liable for the payment of a fee of five thousand US dollars [or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises.
Q14. How the fees shall be paid in India?
Ans: The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”: Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account “0210-Medical and Public Health, 04- Public Health, 104-Fee and Fines”, and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.
Q15. Is there any system of prescreening of applications for issue of grant of Registration Certificate/ Import Licence at the time of submission at CDSCO (HQ) New Delhi?
Ans: Yes, application will be prescreened as per checklist available under link: http://cdsco.nic.in/
Q16. What is the time period for Grant of Registration Certificate?
Ans: If the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.
Q17. What is the Duration/Validity of "Registration certificate" in Form-41 for New Drugs in India?
Ans: A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Q18. When should an application for Re-Registration of new drug be submitted?
Ans. Applications for Re-Registration should be submitted minimum Nine months ahead of the expiry of the registration certificate.
Q19. What are the requirements for Re-Registration/ Renewal of new drug?
Ans. The requirements for Re-registration of new drugs are remains same as fresh Registration requirements except requirement of hard copy of Plant Master File (PMF) and Drug Master File (DMF) provided there are no changes in the PMF and DMF, However soft copy of PMF and DMF in the form of compact disc shall be provided along with the application.
Q20. Is it possible for an applicant to submit their applications for Registration Certificate (Form 41) and Import License (Form 10) together?
Ans. Yes, an applicant can apply for both Registration Certificate (Form 41) and Import License (Form 10) together, provided Indian agent and importer remain same.
Q21. How much fees for issuance of duplicate copy of "Registration certificate" in Form- 41 for New Drugs in India?
Ans: A fee of three hundred US dollars [or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
Q22. What are the requirements for grant of Import license in Form 10 of New Drug?
Ans. The requirements for grant of import license in Form 10 are available in the CDSCO web page under link http://cdsco.nic.in
Q23. What is the Duration/Validity of "Import Licence” in Form-10 for Medical Devices in India?
Ans: Import Licence, unless, it is sooner suspended or cancelled, shall be valid for a period of three years (Till Registration Certificate is valid).
Q24. When should an application for renewal of Import License be submitted?
Ans. Applications for Import License should be submitted along with the application for Re-Registration provided importer and Indian Agent are remain same or minimum three Month’s ahead of the expiry of the Import License.
Q25. Whether new drugs having valid Import License, can be imported from any notified ports of India?
Q26. Whether multiple Import Licenses are required for new drug that are registered under one Registration Certificate by the same Indian Agent/ Importer in case he wants to import from different notified ports?
Ans. No, Single license may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer to the Importer through which importer can import the products thorough any notified port under Drugs and Cosmetics Act and Rules.
Q27. Whether new drug imported under valid import License can stocked in any other wholesale license premises other than stated in the Import License?
28. What is the time period for Grant of Import license?
Ans: If the application is complete in all respects and information are in order, the Licensing authority may within three months from the date of receipt of an application, issue an import license in Form 10.
Q29. What is the Test license in Form 11?
Ans: The Test Licence in Form 11 is to import small quantities of drugs / New drugs/ Medical Devices/ Biotech drugs / Vaccines/ Diagnostic kits, for the purpose of examination, test or analysis provided that Imported drugs / New drugs/ Medical Devices/ Biotech drugs / Vaccines/ Diagnostic kits, under Form 11 shall not be used for any commercial purposes.
Q30. What are essential documents required for import of New Drugs for Examination, test and analysis in Form11?
Ans: The essential documents required for Import of drugs / new drugs under test License are available in CDSCO website under Link: http://cdsco.nic.in
Q31. What is the Duration/validity of "Test License" in Form-11?
Ans: A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of one year from the date of its issue.
Q32. Whether Registration Certificate and Import License are required to import of API / Bulk Drug?
Ans. Yes, API (Active Pharmaceutical Ingredients) are regulated under the provision of Drugs and Cosmetic Act 1940 and Rules thereunder. Hence Registration Certificate and Import License are required to import into India.
Q33. Whether both legal (If any) and actual manufactures name and address should be stated in the Free Sale Certificate issued by the national Regulatory agency for the purpose of registration of New Drugs in India?
Q34. Any changes in name and/or address of Indian agent/ Importer or change in constitution after issue of Registration Certificate/ Import License are required to be communicated to the Licensing Authority?
Ans. Yes, Indian agent/ Importer shall inform the licensing authority immediately in writing and shall submit fresh application as per Rules.
Q35. Any changes in name and/or address of legal and/or actual manufacturer or change in constitution after issue of Registration Certificate/ Import License are required to be communicated to the Licensing Authority?
Ans. Yes, the manufacturer or his authorized agent in India shall inform the licensing authority immediately in writing in the event of any change in the constitution of the firm and / or address of the registered office / factory premises operating under this Registration Certificate. Where any such change in the constitution of the firm and/or address takes place, the current Registration Certificate shall be deemed to be valid for a maximum period of three months from the date on which the change has taken place unless, in the meantime, a fresh Registration Certificate has been taken from the licensing authority in the name of the firm with the changed constitution of the firm and/or changed address of the registered office or factory premises.
Q36. Whether acquisition/merger of one company by another company is considered as change in constitution of the company?
Q37. What are the changes that require an applicant to make afresh Registration?
Ans. The following changes requires a fresh registration – Any change with respect to manufacturer (legal/ actual) like change in constitution, change in name, change in address, etc. Any change with respect to importer/ Indian Agent like change in constitution, change in name.
Q38. What are the changes which do not require fresh registration and only notification or amendment may be obtained?
Ans. Change in shelf life, change in the method of testing, minor change in manufacturing process not affecting the final product specifications, updating in warnings, precautions, additional instructions and safety etc., labels and packaging (provided proper justification should be provided for the above changes).
Q39. If there is a change in the Indications and/ or Intended use of a registered new drug, does the applicant need to submit a fresh application
Ans. Yes, Fresh 122-A approval reflecting the changes / modification to indications as per new drug rules.
Q40. Whether any minor change which is notified to the Regulatory Authority but CDSCO’s response is awaited can be imported in India?
Q41. What is the time line for response to a change notification?
Ans. 90 working days.
Q42. Can the importers of registered new drug incorporate India-specific requirements on labels after/post landing in India at customs warehouse or place approved by the Licensing Authority?
Ans. Yes, importers of registered new drugs are currently allowed to incorporate India-specific requirements like name and address of importer, import Licence Number on imported medical devices post landing in India at customs warehouse or place approved by the CDSCO prior to release into market.
Q43. If applicant has applied for Registration Certificate and still not issued but in between there is the change has happened in the constitution of either Manufacturer or Indian Agent, address of manufacturer whether fresh fees is required for plant registration and product registration?
Ans. Yes. The applicant has to submit the Fresh application including fee.
Q44. Who will issue Form-9, the manufacturer or the Principle Indian Agent?
Ans. Form-9 can be issued by either the manufacturer OR the Principle Indian Agent.
45. How should the documents be notarized?
Ans. The notary should ensure that documents are properly authenticated by signing each document/page or by providing notarization page (Declaration from notary) having name/number of certificate/documents along with pages eg. “This part includes certificate X (pages), Certificate Y (pages)” etc. and should be intact (Authorized by notary tamper proof) and stapling or pasting not accepted.
Q46. What is the time limit for submission of Query Response?
Ans. There is no time limit for submission of Query Response as per the provision of Drugs and Cosmetics Act and Rules, however, it should be reasonable and justifiable.
Q47. Who is authorized to make a Technical Presentation, on behalf of applicant, when asked by the CDSCO?
Ans. Only Subject Expert or Technical Person of the company/ Institute who is equally competent to make technical presentation.
Q48. Whether the Importer who is having valid Form-10 license but there is some small change in the name of importer or address of Importer still can he import till another license is granted?
Ans. No, at the time of import, the label of the product should comply with details as specified in the Form-10 for the product.
Q49. If my new drug has an adverse event, do I need to report it to CDSCO?
Ans. Yes, to find out more about the adverse event reporting criteria, procedure and timeline, please refer to our website on http://cdsco.nic.in
Q50. Can an importer import a registered new drug having residual shelf life less than 60 % for Commercial or testing purpose?
Note: For any further queries, please visit to http://cdsaindia.in/queries-related-regulatory-affairs