SCHEDULE X DRUGS
We covered with,
- SCHEDULE X DRUGS LIST/NAME /PHARMACY
- Sale of drugs specified in schedule x
- DISPENSING OF SCHEDULE X DRUGS
- STORAGE OF SCHEDULE X DRUGS
- RECORDS OF PURCHASE
- SUPPLY OF SCHEDULE X DRUGS
- DRUGS AND COSMETICS ACT,1945
- ABOUT ALL SCHEDULE IN SHORT
- What are Drug/ registered medical practitioners
SCHEDULE X DRUGS LIST/NAME /PHARMACY
SALE OF DRUGS SPECIFIED IN SCHEDULE X :
Substances specified in schedule X should not be sold by retail and sold only in accordance with the prescription of RMP(REGISTERED MEDICAL PRACTITIONER). In the case of substances specified in schedule X, the prescription should be in duplicate, one copy of which retained by the licensee and preserved at least for two years.
Drugs from schedule X, supplied to registered medical practitioners, hospitals, dispensaries, and nursing homes, shall be supplied only against signed written order and such order should be preserved at least for two years.
A prescription of an RMP against which, drugs from schedule X, supplied should :
Be in writing and signed by the person giving it, with his usual signatures and be dated.
Specify the name and address of the patient or name and address of the owner of the animal if a drug is for veterinary use.
Indicate the total amount of drug supplied and doses to be taken.
DISPENSING OF SCHEDULE X DRUGS :
A prescription containing schedule X drugs,
Must not be dispensed more than once unless stated thereon by the prescriber, that it may be dispensed more than once.
If it contains a direction to dispense for a state number of times or at stated intervals, it must be dispensed only in accordance with the direction.
At the time of dispensing such prescription, the name and address of the dispenser, and the date of dispensing must be noted above the signature of the prescriber on the prescription.
Person dispensing a preparation containing substances specified in schedule x may not supply any other preparation, in lieu thereof whether containing the same substance or not
STORAGE OF SCHEDULE X DRUGS
Substances specified in schedule X kept in a retail shop or premises used in connection therewith shall be stored :
1.Under lock and key in a cupboard or drawer solely reserved for storage of substances.
2.In a part of the premises, separate from the remainder of the premises and which will have access to only by responsible persons.
RECORDS OF PURCHASE
Records of purchase of drugs intended for sale or sold by retail should be maintained by the licenses and such records should contain following particulars.
The date of purchase
The name and address of the person from whom it is purchased and his license number.
The name of the drug, the quantity and batch number.
The name of the manufacturer.
The purchase bills including cash or credit memos should be serially numbered by the licensee and maintained by him in chronological order.
SUPPLY OF SCHEDULE X DRUGS
The drugs specified in schedule x shall be supplied only on a prescription of a registered medical practitioner and such prescription should be in duplicate, one copy of which is retained by the licensee and preserved at least for two years. Unless otherwise stated in the prescription by the prescriber, such drugs must not have to be dispensed more than once.
The supply of drugs specified in schedule x shall be recorded at the time of supply in a bound and serially page numbered register, specially maintained for the purpose and separate pages shall be allotted for each drug and the following particulars shall be entered in the register.
date of transaction
quantity received, if any, the name and address of the supplier and relevant license number held by him
name of the drugs
batch number or lot number
name and address of the purchaser/patient
Reference number of the prescription against which supplies were made
Bill number and date in respect of purchases and supplies made by him.
Signature of the qualified person.
BEFORE YOU UNDERSTAND SCHEDULE X YOU SHOULD KNOW ABOUT ALL SCHEDULE IN SHORT AND DRUGS AND COSMETICS ACT,1945 AND RULES THEREUNDER 1945.
Schedule specified under drugs and cosmetics act, 1940 and rules thereunder 1945.
Schedule to the act
The drug and cosmetics act was passed in 1940, (10th April 1940), with the main object to regulate the import, manufacture, distribution, and sale of drugs and cosmetics. The act regulates the imports of drugs into India so that no substandard or spurious drug will find its way in the country. The act regulates the manufacture by making
provisions, and rules, which provides control over the manufacture of spurious or sub-standard drug in the country. the act also provides for the establishment of the “ Drug technical advisory board “ to advise the government on technical matters arising out of the administration of the act and Drug consultative committee to advise to the board and government to secure uniformity in the administration of the act throughout India.
1.first schedule: list of ayurvedic, Siddha and Unani books
2.second schedule: standard to be compiled with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed.
Schedule in pharmacy
- schedule A – list of forms used for making applications for issuing licenses, granting licenses, sending memorandums.
- Schedule B -fees for test or analysis by the central drug laboratory or government analyst.
- Schedule C – biological and special products.
- Schedule C(1) – other special products ( the import, manufacture, and sale of schedule c and c(1) drugs governed by special provisions)
- Schedule D – class of exempted drugs, which are exempted from a certain provision applicable to the import of drugs.
- Schedule E-list of poisonous substances omitted (22-6-82)
- Schedule E(1) – list of ayurvedic, Siddha and Unani poisons substances.
- Schedule F – provisions applicable to blood bank requirements and licensing to process blood components.
- Schedule F(1) – provisions applicable to vaccines, antisera and diagnostic antigens.
- Schedule F(2) – standards for surgical dressings.
- Schedule F(3) – standards for umbilical tapes.
- Schedule FF- standards for ophthalmic preparations.
Glist of substances required to be taken only under the supervision of a registered medical practitioner.The drugs to be labeled with words caution: it is dangerous to take this preparation except under medical supervision.
- Schedule H – prescription drugs that are required to be sold by retail only on the prescription of a registered medical practitioner.
- Schedule I – calculation of the proportion of poisons in certain cases – ( omitted) (22-6-82)
- Schedule J – list of diseases and ailments which a drug may not claim to prevent or cure.
- Schedule K – list of drugs exempted, from certain provisions applicable to the manufacture of drugs and sale of drugs.
- Schedule L – list of drugs to be sold on prescription only.(omitted) (22-6-82)
- Schedule M- good manufacturing practices and requirements of factory premises, plant, equipment et., for the manufacture of drugs.
- Schedule M(1) – requirements of factory premises, plant, equipment, etc. for the manufacture of homeopathic drugs.
- Schedule M(2) – a requirement of factory premises, plant, equipment for the manufacture of cosmetics.
- Schedule M(3) – requirements of factory premises for the manufacture of medical devices.
- Schedule N – list of minimum equipment for the efficient running of a pharmacy.
- Schedule O – standards for disinfectant fluids.
- Schedule P – list of periods of drugs.Schedule P(1) – pack sizes of drugs.
- Schedule Q – list of coal tar, color permitted to be used in cosmetics and list of colors permitted to be used in soaps.
- Schedule R – standard for condoms made up of rubber latex intended for single use.
- Schedule R(1) – standard for medical devices.Schedule S – standard for cosmetics.
- Schedule T – Requirements for factory premises and hygienic conditions for the manufacture of ayurvedic ( including Siddha ) and Unani drugs.
- Schedule U – particulars to be shown in manufacturing and analytical records of drugs.
- Schedule U(1) – particulars to be shown in manufacturing records of cosmetics.
- Schedule V – standards for patent and proprietory medicines and for patent and proprietory medicines containing vitamins.
- Schedule W – list of drugs which shall be marketed under generic name only.
- Schedule X – list of habit-forming, psychotropic and other such drugs.
- Schedule Y – requirements and guidelines on clinical trials, for import and manufacture of new drugs.
And also you should know
What is Drug?
All medicines for internal or external use of human beings or animals and all substances intended to be used for; or in the diagnostic, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
Registered medical practitioner:
A person holding a qualification granted by an authority specified in section 3 of Indian medical degrees act, 1916 or specified in the schedules to the Indian medical council act 1956.
Reference by: pharmaceutical jurisprudence book by Nirali Prakashan.
For more info go on WIKIPEDIA