The
Maharashtra Food and Drug Administration (FDA) rolled out a series of workshops
in Mumbai a week ago to sensitise pharmacists in the medical stores on Good
Pharmaceutical Practices (GPP), Good Distribution Practices (GDP) and Good
Storage Practices (GSP).
Till date 20 workshops have been concluded under the mentorship of Maharashtra FDA Commissioner Pallavi Darade covering areas like Bandra, Vile Parle, Andheri and Borivali in the city in which aspects on proper storage was touched upon for the sake of patient safety.
During the workshops, the pharmacists were instructed to store the drugs at appropriate temperature at clean place away from direct sunlight. It was also clearly spelt out during the workshops that expired drugs, returned drugs, unsaleable stock or breakage should be stored separately and labelled as ‘expired drugs’ ‘not for sale’ and record of returns of such stock should be maintained and preserved for at least three years.
Till date 20 workshops have been concluded under the mentorship of Maharashtra FDA Commissioner Pallavi Darade covering areas like Bandra, Vile Parle, Andheri and Borivali in the city in which aspects on proper storage was touched upon for the sake of patient safety.
During the workshops, the pharmacists were instructed to store the drugs at appropriate temperature at clean place away from direct sunlight. It was also clearly spelt out during the workshops that expired drugs, returned drugs, unsaleable stock or breakage should be stored separately and labelled as ‘expired drugs’ ‘not for sale’ and record of returns of such stock should be maintained and preserved for at least three years.
Veterinary
medicines should be stored in separate compartment and display ‘Veterinary
medicines’ ‘not for human use’. Insecticides / pesticides/poisons should be
stored separately away from drugs to be taken internally and label it.
Laws
governing drugs were also touched upon like Drugs & Cosmetics Act, 1940
& Rules, 1945, Drugs Price Control Order, 2013, Narcotic Drugs &
Psychotropic Substances Act, 1985 and Rules 1985, Drugs and Magic Remedies
(Objectionable Advertisements) Act, 1954 and Rules 1955 and Poisons Act 1919
and Rules there under.
Other
laws related to pharmacy profession were also discussed like Pharmacy Act
1956Pharmacy Practice Regulations 2015, Code of ethics and laws related with
business/profession.
It was instructed that retail selling to be done under direct and personal supervision of registered pharmacist, proper bills to be given after supply of any drug on a prescription of a registered medical practitioner and proper maintenance of purchase bills. All records should be made available to the inspector for inspection, whenever required and should be preserved for not less than two years from the date of the last entry.
Drugs specified in Schedule H, H1 or X shall be sold by retail in accordance with the prescription of a registered medical practitioner (RMP). There should be no substitution of Brand also. In case of drugs specified in schedule X- prescriptions should be in duplicate. The supply of above drugs to RMP’s, hospitals and nursing homes against signed orders; orders should be preserved for two years. The prescription should not be dispensed more than once. Prescriptions to be stamped with the name, address and date of the supplier. Schedule X / Narcotic drugs to be stored under lock and key arrangement.
The licenses shall be displayed in a prominent and conspicuous place in a part of the premises open to the public in such manner as Display ‘Chemist And Druggist’/‘Drug Store’/‘Pharmacy’ on the premises board and drugsneed to be purchased only from license dealers.
On sale bill, retailers should mention name and address of patient, name and address of doctors, name of drugs, dosage form (tablets/capsules /inj., etc), name of manufacturer, batch no., quantity, rate, and signature of registered pharmacist for scheduled- h/h1 drugs and/or competent person approved by licensing authority.
For the sale of veterinary medicines, name and address of owner of the animal should be mentioned on the sale bill. Check all the details of the drugs before accepting and making available for sale. Allopathic drugs, cosmetics, ayurvedic or homoeopathic drugs available for sale should be manufactured by license holder manufacturers only.
Purchase bill should be maintained and preserved after giving chronological order of purchase. Scheduled – X and Narcotic drugs should be stored in lock and key arrangement. An inspection book has to be maintained in form 35 in the premises which can be purchased from FDA office.
Source: Pharmabiz.com-28th November,2017
