MANUFACTURE OF DRUGS
Manufacture in relation to any drug or cosmetic, includes
any process or part of process for making, altering, ornamenting, finishing,
packing, labeling, braking up or otherwise treating any drug or cosmetic with a
view to its sale & distribution but does not include the compounding or
dispensing of any drug or packing of any drug in ordinary course of retail
business
Following licenses are provided for manufacture of drugs
under D&C Act
- Drugs
other than those specified in Schedule C, C1 & X - Drugs
specified in Schedule C, C1 but not specified in Schedule X - Drugs
specified in Schedule C, & C1 - Drugs
specific in Schedule X but not in Schedule C & C1 - Drugs
specified in Schedule C, C1 and X - Drugs
for the purpose of examination, test or analysis - Loan
Licenses - Repacking
Licenses - Blood
products
Repacking is also a manufacturing for the purpose of the
act.
If drugs are manufactured in more than one set of premises,
a separate application is to be made & separate license shall be issued in
respect of each such premises.
Licenses for manufacture or sale or distribution of drugs
are granted or renewed by Central License Approving Authority (CLAA) appointed
by the central government.
CLAA can delegate his power of signing licenses to any other
person under his control with approval of the Central Government.
Manufacture
- Prohibition
of manufacture - Manufacture
of other than in Schedule-C/C1 - Manufacture
of those in Schedule-C/C1 - Manufacture
of Schedule-X drugs - Loan
license - Repackaging
license - Offences
& Penalties
Types of manufacturing licenses
Prohibition of manufacture
- Drug
not of standard quality or misbranded, adulterated or spurious. - Patent
or Proprietary medicine - Drugs
in Schedule-J - Risky
to human beings or animals - Drugs
without therapeutic value - Preparation
containing cyclamates
Prohibition for the manufacture & sale of Certain
Drugs
- From
the date notified by the State Government, no person shall himself
manufacture for sale or distribution
or sell or distribute-
ü Any
drug which is not of standard quality or is misbranded, adulterated or
spurious;
ü Any
cosmetic which not of standard quality or is misbranded, adulterated or
spurious;
ü Any
patent or proprietary medicine whose formulae is not disclosed on label
or the container;
ü Any
drug which purports to cure, mitigate or prevent any disease specified in
Schedule J;
ü Any
cosmetic containing any ingredient which may render it unsafe or harmful for
use;
ü Any
drug or cosmetic in contravention of this act or rules thereunder;
ü Any
drug or cosmetic which has been imported or manufactured in contravention of
the provisions of this Act or Rules thereunder or in contravention of the
conditions of a license.
- Every
person not being manufacturer of a drug or cosmetic or his agent for the
distribution shall if so required disclose to the inspector the name
address and other particulars of the person from whom he procured the drug
or cosmetic. - A
drug or cosmetic shall not be rendered to be misbranded, adulterated or
spurious or below standard quality, if-
-There has been added thereto some innocuous substance or
ingredient required for its manufacture or preparation as an article of
commerce in state fit for carriage or consumption, & not to
increase the bulk, or weight or measure of the drug or cosmetic
or to conceal its inferior quality or other defect.
-In process of manufacture, preparation or conveyance some extraneous
substance has been unavoidably become inter-mixed with it, however this
does not apply in relation to any sale or distribution of the drug or cosmetic
occurring after the vendor or distributor becomes aware of such inter-mixture.
- There
are two types of conditions for all manufacturing licenses
-Conditions which are to be satisfied before
a license is granted
-Conditions which are to be satisfied after
the license is granted.
Manufacture of Drugs other than those specified in
Schedule C & C1
- Application
for the grand or renewal of license for the manufacture of drugs other
than those specified in schedule C, c1 & X ‘d be made to LA
in Form 24 & for manufacture of Schedule X drugs in Form 24F.
Respective licenses are issued in form 25 & 25F - Application
for grand/renewal of such license shall be made for up to 10 items in each
category in Form 24-A accompanied by fee of 6000 & an inspection fee
of Rs. 1500 to LA & license shall be issued in Form 25A. - Additional
fee of Rs 300 per item is payable for each additional item - License
in form 25 or 25F remains valid for a period of 5 years on and from
the date on which it is issued. - If
application for renewal is made before its expiry, or application made
within 6 months of expiry, after payment of additional fee, the license
shall continue to be valid - License
shall deemed to have expired if the application for its renewal is not
made within 6 months of its expiry.
Conditions
- Premises
should comply with schedule ‘M’ - Adequate
facility for testing, separate from manufacturing - Adequate
storage facility - Records
maintained for at least 2 years from date of Exp. - Should
provide sample to authority - Furnish
data of stability - Maintain
the inspection book - Maintain
reference samples from each batch
Manufacture of drugs those in Schedule-C/C1(Biological)
Conditions
- Drugs
must be issued in previously sterilized sealed glass or suitable
container - Containers
should comply with Schedule-F - Some
classes should be tested for aerobic & anaerobic micro-organism.eg.
Sera, Insulin, Pituitary hormones. - Serum
should be tested for abnormal toxicity - Parenteral
in doses of 10 ml or more should be tested for freedom from Pyrogens - Separate
lab. for culture & manipulation of spore bearing Pathogens - Test
for sterility should be carried out.
Manufacture of drugs specified in Schedule C, C1
& X
- Application
for the license of manufacturing drugs specified in Schedule C, C1
excluding those specified in Schedule X should be made to the LA in Form
27 & for manufacture of drugs specified in Schedule C, C1
& X in for 27B. Respective licenses are issued in Form 28 & 28B. - Application
for including any additional drug in the license should be accompanied by
a fee of Rs.50 for each drug subject to a maximum of Rs.500 - Conditions
for the grant of license: Before the grand of license, the following
conditions must be complied by the applicant
1. The
manufacture will be conducted under the active direction of a competent
technical staff consisting at least one person who is a full time employee
& who is
-A graduate in pharmacy/pharmaceutical chemistry of a
recognized University with at least 18 months practical
experience after graduation in manufacture of drugs to which this license
applies.
-A graduate in science of a recognized University who passed
in degree with chemistry or microbiology as principal
subject & had al least 3 years
experience in the manufacture of drugs to which the license applies.
C,C1 …27
C,C1,X……………………………27B
-A graduate in medicine of a recognized University
with at least 3 years’ experience in manufacture of relevant drugs; or
-A graduate in chemical engineering of a recognized
University with at least 3 years’ experience in manufacture of relevant drugs;
or
-Holding any foreign qualification comparable in quality,
content and training with above qualifications & is permitted to work as
competent staff by Central Government
2. The factory conditions must comply with the conditions
prescribed in Schedule M and M3
3. Applicant should provide adequate space, plant &
equipment for any or all manufacturing operations as prescribed in Schedule M
& M3
4. Applicant should provide adequate staff, premises and
laboratory equipment for carrying out such tests for strength, quality
& purity of substances as required under the rules.
5. Adequate facilities for the storage of
manufactured drugs should be provided.
6. Data on stability of drugs that may deteriorate, for
fixing the date of expiry shall be furnished to LA.
7. Licensee shall comply with requirements of GMP.
8. For manufacture of patent or proprietary medicines, data
should be provided to LA that justifies that the medicines are: stable under
conditions of recommended storage.
contains
such ingredients & in such quantities for which there is therapeutic
justification
- License
in form 28 & 28B remains valid for a period of 5 years on and from the
date on which it is issued. - If
application for renewal is made before its expiry, or application made
within 6 months of expiry, after payment of additional fee, the license
shall continue to be valid - License
shall deemed to have expired if the application for its renewal is not
made within 6 months of its expiry. - Large
Volume Parenteral means the sterile solutions indented for
parenteral administration with a volume of 100 ml or more in one container
of the finished dosage form indented for single usage.
Conditions of the License
1. Licensee
should provide & maintain, adequate staff & adequate premises and plant
for the proper manufacture & storage of substances
2. Licensee
should maintain records of the manufacture as per particulars given in schedule
U.
3. Licensee
should allow Inspectors to enter any premises where manufacture is carried on
& to inspect the process of the manufacture.
4. Licensee
should allow inspectors to inspect all registers and records maintained under
these rules & to take samples of manufactured product
5. should allow the LA to inspect if any changes
in expert staff & any material changes in premises or plant since date of
last inspection.
6. On
request by LA licensee should furnish form every batch, a sample of adequate
quantity for any examination
7. If
any batch has been found out by LA not to confirm with the standards, licensee
should withdraw the remainder of batch from sale.
8. should
maintain a Inspection book to enable inspector to record his impression.
9. should
maintain reference samples of each batch of drugs manufactured by him, in a
quantity twice than that sufficient for conducting all tests.
10. should forward to LA of state a statement of
sales effected to manufacturers, wholesalers, retailers, hospitals, nursing homes,
dispensaries every three months.
Manufacture of Schedule-X drugs
Conditions
§ Accounts
of all transactions regarding manuf. should be maintained in serially.(Preserved for 5 years)
§ Have
to sent invoice of sale to licensing authority every 3 months
§ Store
drugs in direct custody of responsible person.
§ Preparation
must be labeled with XRx
§ Marketed
in packings not exceeding
§ 100
unit dose –Tablets/Capsules
§ 300
ml- Oral liquid
§ 5
ml – Injection
Manufacture of Drugs for Examination, Tests or Analysis
- License
is necessary for the manufacture of any drug in small quantity for the
purpose of examination, test or analysis. - If a
person proposing to manufacture does not hold license i) to manufacture
drugs other than those specified in Schedule C, C1 & X, or
ii) to manufacture drugs specified in Schedule C, C1 in respect
to such drugs; he should obtain license in Form 29. - If
drug is not recognized as safe for use, license in Form 29 is only granted
after producing no objection certificate from LA appointed by Central
Government. - License
remains valid for a period of one year time - Drugs
should be kept in containers bearing labels indicating the purpose for
which it has been manufactured. - If
the drugs are to be supplied, it should bear label stating name &
address of manufacturer, scientific name of substance & purpose for
which it has been manufactured.
Conditions for License
- Drugs
should be used exclusively for the purpose for which they are
manufactured - Licensee
should allow inspector to inspect the premises & satisfy himself that
only examination, test or analysis is being conducted. - Licensee
should keep record of quantity of drugs manufactured and supplied
to any person. - Licensee
should maintain inspection book to enable inspector to record his
impression and defects noticed. - Licensee
must comply with any rules made subsequently and of which the LA has
given him NLT one months’ notice.
Manufacture of New Drugs
- Defined
as a drug the composition of which is such that it is not generally
recognized among experts as safe for use under conditions recommended; or - Suggested
on the label & includes any drug the composition of which is such that
the drug as a result of investigations for determining its safety for use
under such conditions, is so recognized but which has not otherwise than during course of such
investigations, been used to any large extend for any appreciable length
of time under the said conditions - Provisions
applicable for the manufacture of new drugs whether classifiable under
schedule C & C1 or otherwise:
-No new drug can be manufactured unless prior approval of
the LA has been taken.
-Applicant should produce all documentary & other
evidence relating to the standards of quality, purity, strength & such
other information as may be required including the results of therapeutic
trials carried out on the new drug.
-While applying for a license to manufacture a new drug, or
its preparations an applicant should produce along with his application
evidence that the drug has already been approved.
Loan License
Definition:
A person (applicant) who does not have his own arrangements
(factory) for manufacture but who wish to manufacturing facilities owned by
another licensee. Such licenses are called Loan licenses.
Licence is obtained from licensing authority (FDA) on
application in prescribed forms (24-A, 27-A) with prescribed fees.
Loan licenses are issued for:
1)
Drugs other than specified in C/C1 & X.
2)
Drugs specified in Schedule-C/C1
- A
loan license means a license which a LA may issue to a applicant who does
not have his own arrangements for manufacture but who intends to avail
himself of the manufacturing facilities owned by another licensee. - Issued
for the manufacture for sale or distribution of drugs other than those
specified in Schedule C, C1 & X. - Application
for license is made in Form 24-A & the license is issued in Form
25-A. - Before
grant of license, the LA shall get the premises inspected by one or more
inspectors. - Inspector
shall check into all the portions of the plant & shall also inquire in
professional qualification for the technical staff employed. - For
the manufacturing of additional items, an application must be made to LA. - Licensee
is required to test each batch of raw materials & finished products
& the records must be maintained for a period of 5 yrs from the
date of manufacture. (2yrs in case of drugs having expiry date, from the
date of expiry) - Loan
license is deemed to be cancelled or suspended if license owned by loan
licensee, whose manufacturing facilities is been availed by licensee is
cancelled or suspended.
Repacking Licenses
Repacking license are granted for breaking up of any drug
other than those specified in Schedule C, & C1, on application
to LA in Form 24B & license is issued in Form 25B subject to
satisfying the following conditions:
- The
repacking operation must be carried out under hygienic conditions &
under supervision of competent staff namely,
a) A
person who holds an approved Diploma in Pharmacy or is an Registered
Pharmacist.
b) A
person who has passed intermediate examination with Chemistry as principal
subject.
c) A
person who has passed matriculation & has at least 4 yrs. practical
experience in manufacturing, dispensing or repacking of drugs.
- Factory
conditions must specify conditions prescribed in Schedule M. - Applicant
must have in his premises adequate facilities for the testing of drugs.
Which is separate from the repacking unit. - License
must be kept at licensed premises & produced on request of DI - 5. Any
change in competent staff must be reported to LA - 6. For
repacking of any additional items, application must be made to LA. - 7. The
label on repacked drugs should mention the name & address of the
licensee & his license number preceded by the word ‘Rpg. Lic. No.” - 8. The
license remains valid up to 31st December of the year
following the year in which it is grated.
Definition:
Process of breaking up any drug from a bulk container
into small packages and labeling with a view to their sale and distribution.
Repackaging of drugs is granted of drugs other than
Schedule-C/C1 and X.
Penalties Related to Manufacture
|
OFFENCES |
PENALTIES |
|
Manufacture of any spurious drugs |
a) 1-3 b) 2-6 |
|
Manufacture of adulterated drugs |
a) 1 b) 2 |
|
Manuf. of drugs in contravention of the provisions |
a) Imprisonment b) Imprisonment |
Manufacture of cosmetics
Prohibited for the following classes :
- Misbranded
or spurious cosmetics and of substandard quality - Cosmetics
containing hexachlorophene or mercury compounds - Cosmetics
containing color which contain more than-
–
2 ppm of arsenic
–
20 ppm of lead
–
100 ppm of heavy metals
- Eye
preparations containing coal-tar color