MANUFACTURE OF DRUGS (OTHER THAN HOMEOPATHIC) FOR

SALE

BY:ROBIN GULATI

INTRODUCTION TYPES OF LICENSES:-oLICENSE FOR MANUFACTURINGoLOAN LICENSE FOR MANUFACTURING

oREPACKING LICENSE GENERAL CONDITIONS MANUFACTURE OF DRUGS FOR EXAMINATION, TEST OR ANALYSIS

CONTENTS

License issued in a specified form for manufacture of specified category of drugs.

For license, applications made in a prescribed form to the licensing authority.

Separate license for manufacturing of drugs at more than one premises. Hence, a separate application form.

License granted on satisfaction with the fulfillment of the provisions under the D&C Act 1940.

INTRODUCTION

* License renewed from time to time.*Before granting license the license

issuing authority send the inspectors who examines:Premises Plant and appliancesProcess 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 by the inspector.

After complete satisfaction of the provisions a license is issued in a prescribed form along with a triplicate copy of it.

Types of licenses granted for the manufacturing of drugs for sale:-1. License for manufacturing of

drugs.2. Loan licenses for manufacturing

of drugs.3. Repacking license

TYPES OF LICENSES

Issued to a person or organization who have their own arrangements for the manufacturing and standardization of drugs.

Different licenses required to manufacture different class of drugs.

1.Manufacturing license

Issued to a person who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee.

2.Loan license

Before granting the license, the licensing authority shall be satisfied about the manufacturing unit regarding the following:-a.Adequate equipment and staffb.Capacity for manufacturec.Facilities for testing

Granted for the purpose of breaking up any drug from a bulk container into small packages and the labelling of each package with a view to its sale and distribution (but does not include compounding or dispensing).

Issued for drugs other than those specified in schedules C & C1 and schedule X.

Application made in a specified form accompanied with the prescribed fees.

3.Repacking license

TYPE OF LICENSE CLASS OF DRUGS FORMS

1. Manufacture of drugs for sale and distribution

a. Grant of or renewal of a license to manufacture drugs other than those specified in Sch C, C1 & part XB.

b. To manufacture for sale drugs specified in Schedule X and part XB.

c. To manufacture drugs specified in Sch C, C1 excluding those specified in Sch X and part XB.

FORM NUMBERSApp Grant

of license

Renew Certif

24

24F

27

25

25F

28

26

26F

26

Types of license

Class of drugs App. GOL RC

d. To manufacture drugs specified in Sch C, C1 & X.

e. For manufacture or sale or for distribution of large volume parentrals/sera and vaccines excluding those specified in Sch X and part XB.

f. To manufacture drugs for the purpose of examination, test or analysis.

27B

27D

30

28B

28D

29

26

26H

License not

renewed

Types of license

Class of drugs App. GOL RC

2. Loan license

3. Repacking license

a. To manufacture drugs other than those specified in Sch C, C1 & X.

b. To manufacture for sale of drugs specified in Sch C & C1.

a. To repack for sale and distribution of drugs other than those specified in Sch C, C1 & X.

24A

27A

24B

25A

28A

25B

26A

26A

26B

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.

GENERAL CONDITIONS

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.

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.

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 74):-

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 in Schedule X used for the manufacture:

• 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 production:

1.Date of manufacture.

2.Name of the drug.

3.Batch Number.

4.Quantity of raw material used in manufacture

5.Anticipated yield.

6.Actual yield,

7.Wastage,

8.Quantity of the manufactured goods transferred.

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 for drugs specified in schedule C, C1 (excluding sch.X and part XB) and those specified in schedule 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 of LVP, Sera and Vaccines shall be issued in Form 28-D.

Before the grant of the license in form 28 or 28B or 28D the applicant shall be complied with the general conditions as specified for grant of license in 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.

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.

Conditions for the grant or renewal of a loan license to manufacture patent and

proprietary medicines:-

The formulation should be stable under the recommended conditions of storage and contain such ingredient in such quantities for which there is therapeutic justification.

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.

Conditions of loan license: (Rule 71B, 74B, 76A, 78A)

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.

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.

Conditions for the grant or renewal of ‘Repacking’ license

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.

License to be obtained in form 29. Application to be made in form 30

accompanied with the prescribed fee. License valid for a period of 1yr from the

date of 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.

MANUFACTURE OF DRUGS FOR 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.