IMPORTANT NOTES FOR GPAT
“JURISPRUDENCE”
????SCHEDULE TO THE RULES????
A ????perform for application for the licences, issues and renewal of licences, for sending memoranda the act.
B ???? Rates of fee for test or analysis by the central drug laboratory or the government analysist.
C ???? List of biological and other special products whose import, sale,distribution and manufacturing are governed by special provision.
C1 ???? list of biological and other special products whose import, sale, distribution and manufacturing are governed byy special provision..
D ???? List of the exempted from the provisions of import of drugs.
E ???? list of poisonous substance under the ayurvedic
(Including sidha) and Unani systems of medicine.
F&F1 ???? provision applicable to the production ,testing ,storage, packaging, and labelling of biological and other special products.
F2 ???? standard for surgical dressing.
F3 ???? standard for sterilized umbilical tapes.
FF ???? standard for ophthalmic preparations.
G ???? List of substances that are required to be used only under medical supervision and which are to be labelled accordingly ..
H ???? List for prescription drugs.
J ????disease or elements which a drug may not purport to prevent or cure
K ???? drugs exempt from certain provision relating to manufacture of drugs
M ???? GMP requirement of factory premises etc. plant and equipment.
M1 ???? Requirement of factory premises etc. for manufacture of homoeopathic preparation.
M2 ???? Requirement of factory premises etc. for manufacture of homoeopathic preparation.
N ???? list of minimum equipment for efficient running of a Pharmacy
O ????Standard for disinfectant fluid.
P ???? life period of drug.
Q???? list of coals tar color tar color permitted to be used in cosmetics
S ???? Standard for mechanical contraceptive. CONDOM
T ???? Requirement of factory premises and hygienic condition for ayurvedic (including sidha) and Unani drugs.
U ???? particulars to be shown in manufacturing, raw material and analytical record of drug..
U1???? particulars to be shown in manufacturing raw material and analytical records of cosmetics.
V ???? standard for patent or proprietary medicines.
W ???? list of drugs which is to be marketed under generic names only.
X ???? list of drugs those importantm anufacture and sales, labelling, and packaging are governed by special provision..
Y ???? requirements and guideline on clinical trials for import and manufacture of new drugs…
