This document outlines standards and testing requirements for biological products and special products intended for parenteral administration in Schedule C. It discusses that these products must use proper names on labels and be sealed in sterile containers. It also requires labeling to meet Indian standards. Products must be tested for sterility, strength, quality, purity, abnormal toxicity, and pyrogens to ensure safety before the expiration date listed on the container.

1. Schedule c
BIOLOGICAL PRODUCTS AND special PRODUCTS
Y. NARENDRA
M.PHARMACY,
(PHARMACEUTICS)

2. 1.Sera
2.Solution of serum proteins intended for injection.
3.Vaccins for parental injections
.
4.Toxins.
5.Antigen.
6.Antitoxins.
7.neo_arsphenamine and analogous substances used for the
specific treatment of infective diseases.
8.Insulin

3. 9.pitutiary(posterior lobe)extract.
10.Adrenalin and solutions of salts of adrenaline,
11.Antibiotics and preparations thereof in form to be administered
parenterally.
12.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.
13.Steriized surgical ligature and sterilized surgical suture.
14.bacteriophages.
15.Opthalmic preparations .
16.Sterile disposable for single use only.

4. 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 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 ,

5. 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 sais 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.

6. TEST FOR STERNGTH ANA 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.

7.  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