Drugs & Cosmetics Act 1940 part III

These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.

1. Drugs & Cosmetics Act 1940 & its rules 1945 Part-III By Pranay Sethiya B.Pharma , ( M.Pharma ) @pj_pranay

2. Prohibition of Manufacture & Sale of Certain Drugs The following drugs are prohibited to manufacture for sale under section 18 of the act: 1. Any drug or cosmetic which is not of a standard quality or is misbranded, adulterated or spurious; 2. Any patent or proprietary medicine, whose formula with the quantities, is not disclosed on the label or container; 3. Any drug which purports or claims to prevent, cure or mitigate any such disease specified in schedule J; 4. Any cosmetic containing any ingredient which may render it unsafe or harmful for use; 5. Any drug or cosmetic in contravention of this act or rules made thereunder; @pj_pranay 1.1

3. Conditions for Grant of License The license is granted, if applicant complies with the following conditions: 1. The manufacture must be conducted under active direction and personal supervision of competent technical staff (approved manufacturing chemist), as per the rules. 2. The licensee and factory premises should comply with the conditions and requirements prescribed under Schedule M respectively. 3. The applicant must provide for various operations, adequate space, plant and equipment, as per Schedule M. @pj_pranay 2.1

4. Conditions for Grant of License 4. The applicant must provide separate testing unit or quality control section with an, independent head, with adequate facilities, for the test and standardization of drugs and raw materials. 5. The applicant should make adequate arrangements for the storage of drugs, manufactured. 6. For patent and proprietary medicines, the applicant must furnish the documents and data related to claims, safety, stability, therapeutic justifications etc., as per the rules. @pj_pranay 2.2

5. Conditions for Grant of License After completion of inspection, Drug Inspector forwards detailed report and his recommendations to the Central Licensing Authority. 1. On receipt of application in the prescribed form along with fees for grant or renewal of license by the applicant, the authority verifies the statement, post performance of the licensee and the above requirements. Thereafter, the Licensing authority on necessary enquiries and satisfaction, grants the license to the applicant in the prescribed form. 2. If Licensing authority is of the opinion that applicant is incapable to fulfill the requirements, it may refuse to grant or renew the license. @pj_pranay 2.3

6. Types of Licenses for Manufacture of Drugs Sr. No. Classes of Drugs Form of Application Form of License 1. Other than Schedule C, C1 and X 24 25 2. Schedule X 24-F 25-F 3. Schedule C and C1 27 28 4. Schedule C, C1 and X 27-B 28-B 5. Loan License (other than Schedule C, C1 and X) 24-A 25-A 6. Loan License (only Schedule C, C1 27-A 28-A 7. Repacking License (other than Schedule C, C1 and X) 24-B 25-B 8. Large volume parenterals , sera and vaccines 24-D 28-D @pj_pranay 3.1

7. Conditions of License for Manufacture of Drugs Manufacture of Schedule C, C1 and X Drugs: Following are the general conditions of license of schedule C, C1 and X drugs in Form 28-B and 28-D; other than schedule C and C1 drugs in Form 25; Schedule X drugs Form 25-F. A licensee must:- 1. provide and maintain staff, premises and equipments (as per Schedule M and Schedule M3 for medical devices). 2. test raw materials and final products of each batch either in the laboratory approved by the licensing authority. 3. maintain records of manufacture and testing of each batch as per schedule U. @pj_pranay 4.1

8. Conditions of License for Manufacture of Drugs 4. allow Drug Inspector to enter and inspect, premises, plant, process of manufacture, means of standardization and tests. 5. allow Drug Inspector to inspect all the registers and records maintained under the rules and to take samples of manufactured drugs. 6. provide the required information to Drug Inspector for ascertaining compliance for provisions of Act and Rules. 7. time to time report to the licensing authority: Changes in expert staff responsible for manufacture or testing. Material alterations in premises or plant. samples of desired drugs and complete protocols of tests applied. @pj_pranay 4.2

9. Conditions of License for Manufacture of Drugs 8. not sell any batch, sample of which is submitted to the licensing authority, until receipt of Certificate of authorization is issued. 9. withdraw from sale remainder of any batch or recall drugs already issued, if licensing authority directs to do so. 10. not sell any drug manufactured under the license unless due precautions, necessary for preserving its properties, are taken throughout the period after manufacturing, also must maintain such quantities of reference samples. 11. comply with the provisions of Drugs and Cosmetics Act, 1940, rules thereunder and such further requirements time to time published in Official Gazette. 12. maintain an “Inspection Book” in Form 35, to record impressions and defects noticed by Drug Inspectors. @pj_pranay 4.3

10. Conditions of License for Manufacture of Drugs 13. comply with requirements of “Good Manufacturing Practices” as per schedule M. 14. The licensee having license to manufacture schedule C, C1 and X drugs in Form 28-B must, ( i ) forward to the licensing authority every 3 months, a statement of sale to the manufacturers, wholesalers, retailers, hospitals, dispensaries, nursing homes, and registered medical practitioners. (ii) maintain as prescribed under rules, accounts of all transactions as regard to use, stock, manufacture, storage and sale of schedule X drugs. (iii) store always schedule X bulk drugs separately under custody of a responsible person. @pj_pranay 4.4

11. Manufacture of Drugs for Test, Examination and Analysis A license is required to manufacture any drug in small quantity for the purpose of examination, test or analysis purpose. 1. If a person proposing to manufacture does not hold a license to manufacture drugs specified in Schedule C and C1 or other than Schedule C, C1 and X, shall obtain a license Form 29 before manufacturing such drugs. 2. The licensee shall carry the manufacture and examination of drugs at the place specified in the license. 3. In case of drugs which are unsafe for use, a license in Form 29 can be granted only on producing NOC (no objection certificate) from the licensing authority. 4. Application must be countersigned by the Head of the Institution, which proposes to undertake the manufacture. @pj_pranay 5.1

12. Manufacture of Drugs for Test, Examination and Analysis 5. License remains valid for a period of 1 year, unless cancelled or suspended. 6. Any drug for the purpose of examination, shall be placed in the containers, labelled for the purpose of manufacturing it, name and address of the manufacturer. Thereafter supplied to the any other manufacturer, when necessary. 7. The licensee shall allow Inspector to inspect the premises and satisfy himself that only examination is conducted. 8. The licensee shall keep a record the quantity of drugs supplied for analysis also maintain ‘Inspection Book’. 9. The licensee shall comply with such requirements specified and of which the authority has given him not less than 1 month’s notice. @pj_pranay 5.2

13. Manufacture of New Drugs As per the Rule 122 E of the Drug and Cosmetic Rules 1945, a New Drug can be: 1. A new substance of chemical, biological or biotechnological origin; in bulk or prepared dosage form; used for prevention, diagnosis, or treatment of disease in man or animal, which except during local clinical trials has not been used in the country; and which, except during local clinical trials, has not been recognised in the country as effective and safe. @pj_pranay 6.1.1

14. Manufacture of New Drugs 2. A drug already approved by the licensing authority for the proposed claims, which is now proposed to be marketed with modified or new claims; or 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, like: Indications. Dosage form (including sustained release dosage form). Route of Administration. @pj_pranay 6.1.2

15. Manufacture of New Drugs 3. All vaccines shall be new drugs unless certified otherwise by the Licensing Authority. 4. 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. @pj_pranay 6.1.3

16. Conditions of License for New Drug 1. No ‘new drug’ can be manufactured, prior to the approval from the licensing authority. 2. The applicant, shall submit data as given in Appendix-1 to Schedule Y, including the results of clinical trials as per the format of Appendix-2 to Schedule Y. 3. While applying for the license, applicant shall furnish the evidence certificate that the drug has already been approved. @pj_pranay 6.2.1

17. Subsequent New Drug Application A Subsequent New Drug application is an application for approval of an already approved new drug by the Central Drugs Standard Control Organization (CDSCO). It can be made for the following cases: 1. Bulk Drug already approved in the country (approved within 4 years). 2. New drug (Formulation) already approved in the country. 3. A drug already approved and proposed to be marketed with new indication. 4. A drug already approved and proposed to be marketed as a ‘New Dosage Form / New Route of Administration’. @pj_pranay 6.3.1

18. Subsequent New Drug Application 5. A drug already approved and proposed to be marketed as a ‘Modified release dosage form’. 6. A drug already approved and proposed to be marketed with Additional Strength. All the applications for approval of New Drug, Fixed Dose Combination and Subsequent New Drug are made under Form 44 (Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial). @pj_pranay 6.3.2

19. Loan License It is issued by the licensing authority, to a person who does not own, arrangements for manufacture but intends to avail the manufacturing facilities owned by another licensee. 1. In the case of pharmacy business is operating its business in more than two states then it is required to obtain a drug license in each state where the business is carried on. A separate license shall be issued in case drugs are sold at more than one place. @pj_pranay 7.1

20. Loan License 2. After the license is granted to the business, the licensee must ensure that all the conditions of the drug license must be complied with during business. In the case of any changes or modification in business activity authority must be informed and all the registers, records, and forms must be maintained in a specified manner. Sr. No. Classes of Drugs Form of Application Form of License 1. Loan License (other than Schedule C, C1 and X) 24-A 25-A 2. Loan License (only Schedule C, C1 27-A 28-A 3. Repacking License (other than Schedule C, C1 and X) 24-B 25-B @pj_pranay 7.2

21. Loan License 3. The licensing authority shall, before the grant of a loan licence , satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan license. 4. Application for manufacture of more than ten items for each category of drug on a loan license shall be accompanied by an additional fee of rupees three hundred per additional item specified in Schedule M and Schedule M3. 5. The licensee shall allow Inspector to inspect the premises and satisfy himself that only examination is conducted. 6. The licensee shall maintain ‘Inspection Book’ in Form 35. 7. The licensee shall comply with further requirements specified by the authority. @pj_pranay 7.3

22. Loan License 8. The licensee shall test each batch of raw materials used and each batch of the final product and also maintain the records of manufacture and testing of each batch as per schedule U. 9. Shall maintain the reference samples from each batch for the period of 3 years. 10. Report to the licensing authority, regarding the changes in expert staff or change in the manufacture or testing units. 11. For Schedule C and C1 drugs, the licensee shall furnish the data of stability and date of expiry to the licensing authority. 12. If the licensing authority is satisfied that a loan licence is defaced damaged or lost or otherwise rendered useless, he may, on payment of a fee of rupees one thousand, issue a duplicate license. @pj_pranay 7.4

23. Repacking License It is granted for the purpose of breaking up any drug than those specified in Schedule C and C1. Sr. No. Classes of Drugs Form of Application Form of License 1. Repacking License (other than Schedule C, C1 and X) 24-B 25-B @pj_pranay 8.1

24. Repacking License 1. Repacking of drugs should be conducted under hygienic conditions under personal supervision of competent person, approved by the licensing authority. 2. The licensee must provide and maintain adequate arrangements for carrying out tests of drugs repacked, in the specified place by the authority. 3. The licensee shall allow Inspector to inspect the premises and to take samples of repacked drugs. @pj_pranay 8.2

25. Repacking License 4. The licensee shall test each batch of raw materials used and each batch of the final product and also maintain the records of manufacture and testing of each batch as per schedule U. Records must be retained for 5 years from the date of repacking. 5. Licensee must allow the Inspector to inspect all the registers and records maintained. 6. The licensee shall maintain ‘Inspection Book’ in Form 35. 7. Shall maintain the reference samples from each batch of repacked drugs, for the specified period. 8. License remain valid for a period of 5 years from the date its granted or renewed, unless suspended or cancelled. @pj_pranay 8.3

26. References Text Book of Pharmaceutical Jurisprudence by Dr. B.S. Kuchekar . Pharmaceutical Jurisprudence and regulatory affairs. Pharmaceutical Jurisprudence by Nirali Prakashan . Drugs & Cosmetics Act & Rules. Forensic Pharmacy By S.P. Agarwal. @pj_pranay

27. Thankyou @pj_pranay