4. INTRODUCTION
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.
5. * 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
6. 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.
7. TYPES OF LICENSES
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
8. 1.Manufacturing license
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.
9. 2.Loan 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.
10. Before granting the license, the licensing
authority shall be satisfied about the
manufacturing unit regarding the
following:-
a. Adequate equipment and staff
b. Capacity for manufacture
c. Facilities for testing
11. 3.Repacking license
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.
12. FORM NUMBERS
TYPE OF LICENSE CLASS OF DRUGS FORMS
App Grant of Renew
license Certif
1. Manufacture of drugs a. Grant of or renewal
for 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.
13. 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
14. Types of Class of drugs App. GOL RC
license
2. 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.
15. 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.
16. 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).
17. 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.
18. 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.
19. 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.
20. 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):-
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.
21. 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 .
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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.
28. 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.
29. 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.
30.
31. 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.
32. 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.
33. 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.
34. 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.
35. Conditions for the grant or renewal of a loan
license 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.
36. The formulation should be stable under the
recommended conditions of storage and
contain such ingredient in such quantities for
which there is therapeutic justification.
37. 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.
38. 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.
39. 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.
40. 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.
41. 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.
42. 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.
43. 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.
44. 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.
45. 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.
46. 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.
47. 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.
48. 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.
49. 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.
50. MANUFACTURE OF DRUGS FOR
EXAMINATION, TEST OR
ANALYSIS
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.
51. 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.
52. 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.
