Guidance Doc On Rule 43

Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government
of India
Central Drugs Standard Control Organisation

(Import Division)
Guidance Document For Central Drugs Standard Control Organisation and Industry
Guidance Document for grant of permission for Drugs imported in Bulk for Non-Medicinal Use as per Rule 43 of Drugs and Cosmetics Rules 1945. IMP & REG/ Document No.: Document Issued on: 19 MAY2011
Title:
Effective from:
Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health and Family Welfare Govt. Of India, New Delhi
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Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India
Preface:
Public Comment:
The proposed guidance for grant of permissions under Rule 43 is being uploaded for the information of all stakeholders likely to be affected thereby for comments, if any. Any person interested in making any suggestion on the proposed Guidance Document may do so in writing for consideration of the CDSCO within a period of seven days from the date of its uploading on the website. Written Comments and Suggestions may be submitted to the Drugs Controller General of India, CDSCO, FDA Bhawan, Kotla Road, New Delhi110002. Electronic Comments may be sent to arvindkukrety@cdsco.nic.in latest by 24rth May 2011.
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Introduction:
This document provides guidance for the grant of permission for Drugs imported in Bulk for Non-Medicinal Use as per Rule 43 of Drugs and Cosmetics Rules 1945. The purpose of this guidance document is to ensure uniform implementation of Rule 43 of Drugs and Cosmetics Rule 1945 by CDSCO. It also specifies requirements to be fulfilled by the Importer for grant of such Permissions. Efforts are also made to identify the list of drugs intended for Non- medicinal Use with the help of Stakeholders.
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For the purpose of this Guidance Document 1. Drug includes

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) All substances intended for use as components of a drug including empty gelatin capsules; and (iv)Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.
2. Rule 43
The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made there under to the extent, and subject to the conditions specified in that Schedule.
3. Schedule-D
Class of drugs Substances not Intended Medicinal Use Extent and conditions of exemption for All provisions of Chapter III of the Act and rules there under subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is of commercial quality.
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Based on the intended use of the product, the drugs that are falling under Schedule-D of Drugs and Cosmetic Rules have been categorised into:
1. Drugs meant for Non- medicinal use. 2. Drugs meant for Animal feed supplement, Feed premix. 3. Drugs meant for further processing/ conversion to other drug.
1.
Drugs meant for Non- medicinal use:

The following documents are required to be submitted for the items specified in Table No. - 1 to the CDSCO (HQ), for grant of necessary permission under Schedule- D, preferably before importing the consignment. i. Covering letter- The applicant should submit covering letter by clearly specifying purpose of application, the drugs to be imported, the intended use of the drug, quantity to be imported, name and address of the manufacturer and list of documents that are being enclosed (Index with page numbers). The covering letter should be duly signed and stamped by the Authorised Signatory, indicating name and Designation of the Authorised Signatory. Legal Undertaking- The applicant has to submit Legal Undertaking on Rs. 100 stamp paper as per the Performa given under Annexure I. (If the drug is imported by the trader for the purpose of further sale to the actual User, Legal Undertaking as per the proforma provided in Annexure-II should be obtained by the Trader from the Actual User. The Trader has to retain such undertaking issued by the actual user for any inspection carried out by the regulators). A copy of Valid Manufacturing Licence for the products to be manufactured, issued by the Competent Authority wherein the imported drug will be used. A copy of letter issued by the Competent Authority stating that the imported drug will be used in the manufacture of said finished product. A copy of Certificate of Analysis of the drug to be imported, issued by the manufacturer. Detailed Justification of the quantity of Drug to be imported. Detailed Technical Literature of the drug to be imported. For Subsequent permission, Reconciliation data of previously permitted quantity in addition to above details.
ii.
iii.
iv.
v. vi. vii. viii.
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Table No.-1
S.NO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46.
Drugs Names Alginic acid Aloe emodin Amitraz Ascorbic acid Aluminium Hydroxide Benfothiamine Benzoyl peroxide Biotin Calcium Carbonate Cinchonine Citric acid Colistin sulphate Chondroitin Sulphate Coumarin Cysteamine HCl Di calcium phosphate Diflorasone Base Disodium carbonate Disopyramide base Empty hard gelatine Capsules Estrone Ethisterone Fish Lipid Oil Ferrous Fumarate Glycerine with pharmacopeial grade Glycine Guanidine hydrochloride Heavy Magnesium Carbonate hesperidine Hydrogen Peroxide Pharmacopeial grade Inositol Isoxepac L - Methionine L-arginine L-Cysteine L-glutamine Lysine Maduramycin Ammonium Monensin Sodium Magnesium carbonate Magnesium oxide Magnesium hydroxide Magnesium Sulphate Mixed tocopherols 50% Mannitol Protamine Sulfate
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47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59.
Pyridoxine HCl Simethicone Emulsion Streptomycin Sulphate Triacetin Threonine Tiamulin Hydrogen Fumarate Vitamin A acetate Vitamin B2 Vitamin B6 Vitamin B12 Vitamin D3 Vitamin E Zinc Gluconate
Drugs meant for Animal feed supplement, Feed premix

2. Before grant of NOC for release of items stated in Table no.-2, the concerned Port Officer should verify/ examine following documentsi. Legal Undertaking- The Importer has to submit Legal Undertaking on Rs. 100 stamp paper as per the Performa given under Annexure I. (If the drug is imported by the trader for the purpose of further sale to the actual User, Legal Undertaking as per the proforma provided in Annexure-II should be obtained by the Trader from the Actual User. The Trader has to retain such undertaking issued by the actual user for any inspection carried out by the regulators). Purchase order/ Proforma invoice of the material to be imported. A copy of Certificate of Analysis of the product to be imported. Table No. - 2 List of the feed grade items which requires NOC from Port Office (CDSCO) for exclusive use in animal feed industry as an animal feed supplement, feed premix.
ii. iii.
I.
Amino Acids
1) L-Lysine Mono HCL 99% Feed grade 2) L-Lysine Sulphate 65% Feed grade 3) DL-Methionine 99% Feed grade
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II. 1) 2) 3) 4) 5) 6) 7) III.
Vitamin Premix Vitamin AD3 Feed grade 1000:200 Vitamin E 50% Feed grade Vitamin D3 0.5 miu/gm feed grade Vitamin B2 80% feed grade Biotin 2% Feed grade Vitamin mineral Premix feed grade (as per formula) Choline Chloride 50% & 60% on Corn Cob carrier Phosphates
1) Mono Calcium Phosphate (MCP) 22% Feed grade 2) Di Calcium Phosphate (DCP) 18% feed grade. IV. 1) 2) 3) 4) 5) V. Antibiotic / Antibacterial Feed Additives ChlorTetracycline 15% Feed grade Dichlozuril 1% feed grade Zinc Bacitracin 10% feed grade BMD-Bacitracin Methyl Disalicylate 15% Feed grade Tylosin Phosphate 10% premix feed grade Anticoccidiostats
1) Maduramycin 1% Feed grade 2) Salinomycin 12% Feed grade
3.Drugs meant for further processing/conversion to other drug

For the import of any substance which attracts the definition of Drug as per the Drugs and Cosmetics Act 1940 for further processing/conversion to manufacture of other drugs, also requires NOC from CDSCO (HQ) this Directorate for each consignment. eg- Erythromycin Thiocyanate for the manufacture of Erythromycin salts, Penicillin G Potassium for the manufacture of Penicillin drugs.
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The following documents are required to be submitted to the CDSCO (HQ), for grant of necessary permission under Schedule- D, preferably before importing the consignment. i. Covering letter- The applicant should submit covering letter by clearly specifying purpose of application, the drugs to be imported, quantity to be imported, name and address of the manufacturer and list of documents that are being enclosed (Index with page numbers). The covering letter should be duly signed and stamped by the Authorised Signatory, indicating name and Designation of the Authorised Signatory. A copy of Valid Drug Manufacturing Licence for the products to be manufactured, issued by the Drug Licensing Authority wherein the imported drug will be used. A copy of letter issued by the Licensing Authority stating that the imported drug will be used in the manufacture of proposed finished product. A copy of Master Formula Record of the product to be manufactured Signed and Stamped by the Authorised Signatory of the Firm. A copy of Certificate of Analysis of the drug to be imported, issued by the manufacturer. Detailed Justification of the quantity of Drug to be imported. Brief Manufacturing Process including Flowchart wherein the imported product will be used. Detailed Technical Literature of the drug to be imported. For Subsequent permission, Reconciliation data of previously permitted quantity in addition to above details.
ii.
iii.
iv.
v. vi. vii. viii. ix.
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Annexure I
Legal Undertaking for the Import of Drugs as per provisions of Schedule D of Drugs and Cosmetic Rules 1945 to be submitted by the Traders (Other than Actual Users) To The Central Drugs Standard Control Organisation
I/We............................................................S/o................................................................ having premises at ......................................................................................................aged about ..........do hereby solemnly affirm state and undertake as under: 1. That I am the importer of........................ (name of the drug) from..................................................................................... (name and full address of the Manufacturer) of................... (Quantity) vide Bill of Entry No.......................dated............. 2. That I undertake to use............ (quantity) of above said drug for Non-Medicinal purpose only. 3. That I Undertake to obtain similar undertaking from the Actual User before sale of the drug as per the proforma provided in Annexure-II. I also undertake to retain such undertaking issued by the actual user for any inspection carried out by the regulators. 4. That I undertake to maintain books and records of transaction of above said drug for which NOC will be granted. 5. That I undertake to allow the Drug Inspectors from the CDSCO to inspect the books and records as well as the actual usage of (Name of the drug) as and when required. 6. I state that that consignment document like Certificate of Analysis, Bill of Entry, invoice etc. clearly mentions Not for Medicinal Use. 7. That the bags/containers carrying (Name of the drug) along with other requirements of labelling and packaging also mentions Not For Medicinal Use. 8. That the data of my previous import is annexed with this undertaking (Optional in cases of subsequent import). 9. That the Legal undertaking of the actual user/purchaser is annexed (shall be submitted at the time of sale) herewith which amongst other thing states clearly that shall not be used for medicinal purpose and it shall not be sold to anyone; which shall use it for Medicinal Purpose. DEPONANT VERIFICATION Verified on this .......day of...... (Month & Year) that the contents of my above undertaking are true and that no part it is false and that nothing material has been concealed here from. DEPONANT
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Annexure II
Legal Undertaking for the import of Drugs as per provisions of Schedule D of Drugs and Cosmetic Rules 1945 to be submitted by the Importer (Actual User)/ Purchaser to The Central Drugs Standard Control Organisation.
I/We............................................................S/o................................................................ having premises at ......................................................................................................aged about ..........do hereby solemnly affirm state and undertake as under: 1. That I am the importer/ Purchaser of........................ (Name of the drug) from..................................................................................... (Name and full address of the Manufacturer) of................... (Quantity) vide Bill of Entry / Purchase order no.......................dated............. 2. That I undertake to use............ (quantity) of above said drug for Non-Medicinal purpose only. 3. That I undertake to maintain books and records of transaction of above said drug for which NOC will be granted. 4. That I undertake to allow the Drug Inspectors from the CDSCO to inspect the books and records as well as the actual usage of said drug as and when required. 5. That the bags/containers of the said drug along with other requirements of labelling and packaging also mentions Not For Medicinal Use. 6. That the data of my previous transaction is annexed with this undertaking (Optional in cases of subsequent transaction). DEPONANT VERIFICATION Verified on this .......day of...... (Month & Year) that the contents of my above undertaking are true and that no part it is false and that nothing material has been concealed here from. DEPONANT
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Guidance Doc On Rule 43

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Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government

Central Drugs Standard Control Organisation

For the purpose of this Guidance Document 1. Drug includes

Drugs meant for Non- medicinal use:

v. vi. vii. viii.

Drugs meant for Animal feed supplement, Feed premix

1) Maduramycin 1% Feed grade 2) Salinomycin 12% Feed grade

3.Drugs meant for further processing/conversion to other drug

v. vi. vii. viii. ix.

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