MANUFACTURE OFDRUGS (OTHER THANHOMEOPATHIC) FOR SALE BY: ROBIN GULATI
CONTENTSINTRODUCTIONTYPES OF LICENSES:-oLICENSE FOR MANUFACTURINGoLOAN LICENSE FOR MANUFACTURINGoREPACKING LICENSEGENERAL CONDITIONSMANUFACTURE OF DRUGS FOREXAMINATION, TEST OR ANALYSIS
INTRODUCTIONLicense issued in a specified form formanufacture of specified category of drugs.For license, applications made in a prescribedform to the licensing authority.Separate license for manufacturing of drugs atmore than one premises. Hence, a separateapplication form.License granted on satisfaction with thefulfillment of the provisions under the D&C Act1940.
* License renewed from time to time.* Before granting license the license issuing authority send the inspectors who examines: Premises Plant and appliances Process of manufacture
Means to be employed in standardizing and the substance to be manufactured.Testing the substance to be manufactured.Professional qualification of the technical staff to be employed.Report forwarded to the licensing authority bythe inspector.After complete satisfaction of the provisions alicense is issued in a prescribed form alongwith a triplicate copy of it.
TYPES OF LICENSESTypes of licenses granted for themanufacturing of drugs for sale:-1. License for manufacturing of drugs.2. Loan licenses for manufacturing of drugs.3. Repacking license
1.Manufacturing licenseIssued to a person or organizationwho have their own arrangementsfor the manufacturing andstandardization of drugs.Different licenses required tomanufacture different class ofdrugs.
2.Loan licenseIssued to a person who does not have hisown arrangements for manufacture butwho intends to avail himself of themanufacturing facilities owned byanother licensee.
Before granting the license, the licensingauthority shall be satisfied about themanufacturing unit regarding thefollowing:-a. Adequate equipment and staffb. Capacity for manufacturec. Facilities for testing
3.Repacking licenseGranted for the purpose of breaking up anydrug from a bulk container into smallpackages and the labelling of each packagewith a view to its sale and distribution (but doesnot include compounding or dispensing).Issued for drugs other than those specified inschedules C & C1 and schedule X.Application made in a specified formaccompanied with the prescribed fees.
FORM NUMBERS TYPE OF LICENSE CLASS OF DRUGS FORMS App Grant of Renew license Certif1. Manufacture of drugs a. Grant of or renewalfor sale and distribution of a license to manufacture drugs 24 25 26 other than those specified in Sch C, C1 & part XB. b. To manufacture for sale drugs specified 24F 25F 26F in Schedule X and part XB. c. To manufacture drugs specified in Sch C, C1 excluding 27 28 26 those specified in Sch X and part XB.
Types of Class of drugs App. GOL RC license d. To manufacture drugs 27B 28B 26 specified in Sch C, C1 & X. e. For manufacture or sale or for distribution of large volume parentrals/sera 27D 28D 26H and vaccines excluding those specified in Sch X and part XB. f. To manufacture drugs for the purpose of 30 29 License examination, test or not analysis. renewed
Types of Class of drugs App. GOL RC license2. Loan a. To manufacture drugs 24A 25A 26A license other than those specified in Sch C, C1 & X. b. To manufacture for sale 27A 28A 26A of drugs specified in Sch C & C1.3. Repacking a. To repack for sale and license distribution of drugs other 24B 25B 26B than those specified in Sch C, C1 & X.
GENERAL CONDITIONS Manufacture conditions for the grant or renewal of license in form 25 or 25F (for drugs other than those specified in Sch C, C1 & X) (Rule 71):-1. Manufacture conducted under the supervision of competent and at least one full time employee. Competent technical staff: a. B.Pharma/ M.Pharma (Pharma. Chem) or equivalent qualification with 18 months prac experience in manft of drugs or 1yr if done training in manft of drugs for 6months during the university course.
b. Graduate in Science with Chemistry as a principle subject and has at least 3yrs prac experience in the manufacture of drugs after his graduation.c. Graduate in Chem Engg or Chem Techn or Medicine with general training and practical experience, extending over a period of not less than 3yrs in the manufacture of drugs, after his graduation.d. Any foreign qualification which is comparable with those prescribed in (a), (b) or (c).
2. Factory premises in compliance with Schedule M.3. Adequate space, plant and equipment for the manufacturing operations.4. Provision and maintenance of adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit.
5. Adequate arrangements for the storage of drugs manufactured.6. The applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines:- a) Contain the constituent ingredients. b) Are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation.
c) Are stable under the conditions of storage recommended. d) Contain such ingredients and in such quantities for which there is therapeutic justification. e) Have the approval.7. Licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M.
Manufacture conditions for the grant orrenewal of license in form 25 or 25F (for drugs other than those specified in Sch C, C1 & X) (Rule 74):- 1. Provide and maintain staff, premises and the equipment as specified in rule 71. 2. Shall comply with the provisions of the Act and of these rules and with such further requirements.
3. Shall either in his own laboratory or in any other laboratory approved by the Licensing Authority test each batch or lot of the raw material for the manufacture of products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of 5 years from the date of manufacture .
4. Shall keep records of the details of manufacture as per particulars given in Schedule U. Records shall be retained for a period of five years.5. Shall allow an Inspector to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs.
6. Shall allow an Inspector to inspect all registers and records, take samples of the manufactured drugs and supply information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules thereunder have been observed.
7. Shall report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority.
8. Shall furnish to the Licensing Authority, the Controlling Authority or to such authorities as they may direct from every batch, or batches of drugs, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied.
9. Any part of any batch of the drug has been found not to conform with the standards of strength, quality or purity as specified, the remainder of the batch from sale should be withdrawn.10.Shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
11.Shall maintain reference samples from each batch.12.The licensee shall- i. Forward a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months.
ii. Maintain accounts of all transactions giving details in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later.
Accounts of the drugs specified inSchedule X used for themanufacture:• 1.Date of issue.• 2.Name of the drug.• 3.Opening balance of stock on the production day.• 4.Quantity received, if any, and source from where received.• 5.Quantity used in manufacture.• 6.Balance quantity on hand at the end of the production day.• 7.Signature of the person in charge.
Accounts of the manufactured drugs:1.Date of manufacture.2.Name of the drug.3.Batch Number.4.Opening Balance.5.Quantity manufactured.6.Quantity sold.7.Name of the purchaser and his address.8.Balance quantity at the end of the day.9.Signature of the person in charge.
13.Shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person.14.Shall comply with the requirements of ‘Good Manufacturing Practices’ as laid down in Schedule M.
Conditions for grant or renewal of license fordrugs specified in schedule C, C1 (excludingsch.X and part XB) and those specified inschedule C, C1 & X: License for drugs specified in schedule C & C1 other than LVP, sera and vaccines, drugs specified in part XB and schedule X is issued in Form no.28. Licence to manufacture for sale or distribution of drugs specified under Schedules C and C(1) (other than LVP, Sera and Vaccines, drugs specified in Part X-B) and Schedule X shall be issued in Form 28-B.
License to manufacture for sale or for distribution ofLVP, Sera and Vaccines shall be issued in Form 28-D.Before the grant of the license in form 28 or 28B or28D the applicant shall be complied with thegeneral conditions as specified for grant of licensein Form 25 or 25F and the following condition:- Shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the data so furnished.
Conditions for the grant or renewal of a loanlicense to manufacture patent and proprietary medicines:- Before license is granted or renewed (in form 25A or 28A) the applicant shall furnish to the licensing authority evidence and data justifying that the patent and proprietary medicine contains the constituent ingredient in therapeutic prophylactic quantities and are safe for use in context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation.
The formulation should be stable under the recommended conditions of storage and contain such ingredient in such quantities for which there is therapeutic justification.
Conditions of loan license: (Rule 71B, 74B, 76A, 78A) Other than conditions for license listed in form 25 or 28 for Schedule C & C1 drugs the licensee shall comply with the following:-1. The licensee shall comply with the provisions of the Act and further requirements if any.
2. Licensee shall test each batch of the raw materials used and finished product manufactured and shall maintain records or register showing the particulars of the tests carried out as specified in schedule U. Records & registers to be maintained for 5yrs and 2yrs after the date of the expiry for the products bearing expiry date on its label.
3. Shall allow the Inspectors to inspect all registers, records and maintained under these rules and shall supply to the Inspector necessary information as he may require for the purpose of ascertaining whether the provisions of the Act have been observed.
4. Shall maintain adequate staff and adequate lab for carrying out tests of strength, quality and purity of the product manufactured or make arrangements with approved institution to carry out such tests, on his behalf.
5. Shall maintain reference sample from each batch in a quantity of drugs required to carry out all tests performed on the batch. The reference sample has to be maintained for 3months from the date of expiry of the product bearing expiry date for a period of 3yrs from the date of manufacture for a product not bearing expiry date.
6. If required by the licensing authority, licensee shall furnish data on the stability of drugs which are likely to deteriorate for fixing the date of expiry, which would be printed on the label.7. The licensee shall maintain the inspection book in form 35.
Conditions for the grant or renewal of ‘Repacking’ license The following conditions should be complied:-1. Repacking operation shall be carried out under hygienic conditions and under supervision of a competent person.2. Factory premises shall comply with the conditions prescribed in schedule M.
3. The applicant shall have adequate arrangements for carrying out tests for the strength, quality & purity of the drugs in his own premises and such unit shall be separate from repacking unit.
4. Repacking of drugs be carried out at all times under the supervision of a competent person approved by the licensing authority.5. The licensee shall provide and maintain adequate arrangements for carrying out tests of the strength, quality and purity of the drugs either in his own premises or with the institution approved for the purpose by the licensing authority.
6. Shall make adequate arrangements for the storage of drugs.7. Shall allow the inspector to enter with or without notice, in any premises, where packing of drugs is carried on and to inspect premises and to take samples of repacked drugs.
8. Testing of raw materials and final product repacked should be done in the licensee’s own lab or in an institution approved for the purpose and shall maintain records showing details of the tests carried out as specified in schedule U and is to be maintained for a period of 5yrs from the date of repacking.
9. Shall allow the inspector to inspect records and registers maintained under these rules and supply other necessary information as required by him.10.Shall maintain an Inspection book in form 35 to enable Inspector to record his impressions and defects noticed.
11.Shall maintain samples from each batch of the drugs repacked by the licensee in a quantity twice the quantity required to carry all the tests on a batch. Reference samples to be maintained for 3months after the expiry date of the products bearing expiry date on the label and 3yrs from the date of repacking in case of other drugs.
MANUFACTURE OF DRUGS FOR EXAMINATION, TEST OR ANALYSISLicense to be obtained in form 29.Application to be made in form 30accompanied with the prescribed fee.License valid for a period of 1yr from the dateof issue.Conditions of a license:-1. drugs manufactured should be exclusively for the purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis.
2. Shall allow any Inspector to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted.3. Shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied.
4. Shall comply with such further requirements of which the Licensing Authority has given him not less than one month’s notice.5. Shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed.