25/03/2016
Schedules
निम्न जानकारी अवश्य पढ़कर शेयर करें ।
The Drugs and Cosmetics
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Rules, 1945 contains
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provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.[1] The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations.[3]
The notable Schedules and their summary:
Schedule G
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: Most of these drugs arehormonal preparations.[4] The drug label must display the text "Caution: It is dangerous to take this preparation except under medical supervision" prominently. Examples of substances under this schedule:Testolactone, Hydroxyurea, Carbutamide,Primidone etc
Schedule H
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: The drug label must display the texts "Rx" and "Schedule H drug. Warning : To be sold by retail on the prescription of a Registered Medical practitioner only"prominently. It can only be supplied to licensed parties. It cannot be sold without a prescription and only the amount specified in the prescription should be sold. The time and date of prescription must be noted. Examples:androgenic, anabolic, oestrogenic andprogestational substances; Alprazolam(Xanax), Hepatitis B vaccine, Ibuprofen,Vasopressin etc.[3]If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts "NRx" and "Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only." on the label prominently.
Schedule X
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: All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years. The drugs must be kept under lock and key. Examples:Secobarbital, Glutethimide etc.
Schedule J:
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Contains a list of various diseases and conditions that cannot be treated under any drug currently in market. No drug may legally claim to treat these diseases.[3]
Other Schedules
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and their summary:
Schedule A
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: Contains various forms and formats of letters for applications of licensing etc.[3]
Schedule B
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: Contains fees structure for government-run labs.
Schedule C
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: Contains various biological products[4] and their regulation. Examples:Serums, Adrenaline etc.[3]
Schedule E
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: Contains various poisons[4] and their regulation. Examples: Sarpa Visha(Snake venom), Parada (Mercury) etc.[3]
Schedule F
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: This contains regulations and standards for running a blood bank.[3]
Schedule F-I
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: This contains regulations and standards for vaccines.[3]
Schedule F-II
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: This contains regulations and standards for surgical dressing.[3]
Schedule F-III
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: This contains regulations and standards for umbilical tapes.[3]
Schedule F-F
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: This contains regulations and standards for ophthalmic ointments and solutions.[3]
Schedule K
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: Contains various substances and drugs and their corresponding regulation.[3]
Schedule M
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: Contains various regulations for manufacturing, premises, waste disposal and equipment.[3]
Schedule N
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: Contains various regulations and requirements for a pharmacy.[3]
Schedule O
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: Contains various regulations and requirements for disinfectant fluids.[3]
Schedule P
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: Contains regulations regarding life period and storage of various drugs.[3]
Schedule P-I
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: Contains regulations regarding retail package size of various drugs.[3]
Schedule Q
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: Contains a list of permitted dyes and pigments in soap and cosmetics.[3]
Schedule R
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: Contains various regulations and requirements for condoms and other mechanical contraceptives.[3]
Schedule S
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: Lists various cosmetics andtoiletries, and directs the manufacturers of cosmetics to conform to the latest Bureau of Indian Standards requirements.[3]
Schedule T
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: Contains various regulations and requirements for manufacture ofAyurvedic, Siddha and Unani products.[3]
Schedule U
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: Contains various regulations and requirements for record keeping.[3]
Schedule V
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: Contains standards for drug patents.[3]
Schedule Y
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: Contains requirement and guidelines for clinical trials.[3]