Overview of Schedule C and C1 Drugs and Licensing Requirements
Schedule C and C1 drugs in India require specific licenses for manufacturing, distribution, and retail selling. Schedule C covers biological and special products like vaccines and insulin, while Schedule C1 includes other special products such as fish liver oil and vitamins. Licensing authorities issue Form 28 for manufacturing and Form 21 for retail sale. Proper labeling and packaging regulations ensure the sale of these substances in sterilized containers. Compliance with these regulations is crucial for the sale and distribution of these substances.
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. 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 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. belonging to the Digitalis group and
. 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 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 OF SUBSTANCE AFTER
. 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 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 intended for parentral
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
