Schedule C and C1 drugs
For manufacturing for sale and distribution of
Schedule C and C(1) drugs, A license on Form 28 is
required which is issued by Drug Department of
concerned state government or center government.
For retail selling of these drug, a license on Form 21
is required where as for wholesale and distribution
purpose, license on Form 21-B is required. Below
are the list of products that are covered under
Schedule C and C(1).
Schedule C: Biological and Special Products
Sera
Solution of serum proteins intended for injection.
Vaccins for parental injections .
Toxins.
Antigen.
Antitoxins.
Insulin
Pitutiary(posterior lobe)extract.
Adrenalin and solutions of salts of adrenaline,
.
Antibiotics and preparations thereof in form to be
administered parenterally.
Any other preparation which is meant for parentral
administration as such or after being made up with
solvent or medium or any other sterile product and
which (a)Requires to be in a refrigirator:or (b)Does
not require to be in a refrigerator.
Sterilized surgical ligature and sterilized surgical
suture.
Bacteriophages.
Opthalmic preparations .
Sterile disposable for single use only.
Schedule C (1): Other Special Products
• Drugs belonging to the Digitalis group and
preparations containing drugs belonging to the Digitals
group not in a form to be administered parenterally.
• Ergot and preparations containing Ergot not in a form
to be administered parenterally.
• Adrenaline and preparations containing Adrenaline
not in a form to be administered parenterally.
• Fish Liver Oil and preparations containing Fish Liver
Oil.
• Vitamins and preparations containing any vitamins not
in a form to be administered parenterally.
.
• Liver extract and preparations containing liver extract
not in a form to be administered parenterally.
• Hormones and preparations containing Hormones not
in a form to be administered parenterally.
• Vaccine not in a form to be administered parenterally.
SPECIAL PROVISIONS RELATING TO BIOLOGICAL AND
OTHER SPECIAL PRODUCTS
• NAME OF SUBSTANCE
If any substance specified in schedule C is advertised or sold
as a proprietary medicine or is contained in a medicine so
advertised or sold, the proper name of the substance shell
appear on the label in the manner prescribed in this part.
• CONTAINER;
No substance specified in schedule C shall be sold or
offered for sale unless it has been sealed in a previously
sterilized container made of glass or any other suitable
material approved for the purpose by the licensing
authority appointed under rule 21
• LABELLING OF MEDICAL DEVICES:
.
The labelling of medical devices shall conform to the
Indian standards specifications laid down from time to
time by the bureau of Indian standards in addition to
any other requirement prescribed under the said rules .
• PROHIBITION OF SALE OF SUBSTANCE AFTER
PRESCRIBED DATE:
No person shall sell, or exhibit for sale any substances
specified in schedule C after the date recorded on the
container, label or wrapper as the date up to which the
substance may be expected to retain a potency not less
then, not to acquire a toxicity greater then that
required or permitted by the prescribed test as the case
may be
.
• STANDARDS:
Every substance specified in schedules C and C(1)
intended for sale shall conform with the standards of
strength, quality, and purity specified in these in these
rules and in schedule applied to samples taken from
the final product after every manufacturing process
has been completed.
TEST FOR STERNGTH AND QUALITY:
• TEST FOR STERILITY
• TEST FOR PRESCENCE OF LIVING AEROBIC OR
ANAEROBIC BACTERIA;
• APPLICATION TEST FOR STERILITY;
a) To samples taken from each of the substance before the
operation filling and sealing the containers in which it to
be issued has commenced except preparations, which
after being sealed in the containers are to be sterilized by
heat ,in a manner satisfactory to the licensing authority
b) To the contents of sample containers when ready for use.
.
• METHOD OF TESTING
1)If at this examination no growth of micro-organisms
is found in any tube ,the sample may be treated as
having passed the test .
2)If at this examination a growth of micro-organisms is
visible ,further samples may be taken and the tests
may be repeated on the further samples taken.
.
TEST FOR FREEDOM FROM ABNORMAL TOXICITY
As per current edition of Indian pharmacopeia in the
case of each batch of the serum tested by the license
or by an institution approved by the licensing authority
for the purpose of carrying out the test on its behalf.
TEST FOR PYROGENS
Solution of substances intended for parentral
administration in large volumes shall be pyrogen free
and tested for pyrogens .if water or any other aqueous
solvent is supplied along with the substances for
preparing such solutions ,it shall also be pyrogens free
and tested for pyrogens
Schedule G:
• Products or Substances that are included in this list
should mention below lines at label:
• ‘Caution: It is dangerous to take this preparation
except under medical supervision’
• Conspicuously printed and surrounded by a line
within which there shall be no other words;
List of drugs and active pharmaceutical ingredients
come under Schedule G is as below:
Aminopterin
L-Asparaginase
Bleomycin
Busulphan; its salts
Carbutamide
Chlorambucil;its salts
Chlorothiazide
Chlorpropamide; its salts
Chlorthalidone
Thiotepa
Tolbutamide
Ethosuximide
Glibenclamide
