In a first of its kind initiative taken up in the country, the Maharashtra Food and Drug Administration (FDA) has sensitised nearly 70,000 retailers across the state on good pharmaceutical practices through 300 workshops conducted over a period of two months.
As part of the sensitisation drive which will cover another 10, 000 retailers, a check list is issued to all the retailers to help them to be self-compliant before a surprise raid or routine inspection by the state regulator.
“The workshops conducted across the state has drawn positive responses as it has given a common platform to both the drug retail licensees and the state regulator to seek answers on regulatory requirements of the drug retail supply chain towards maintaining compliance,” informed Maharashtra FDA Commissioner Pallavi Darade.
“Through this exercise, the regulator has addressed compliance needs of close to 10,000 medical stores in Maharashtra,” she added
FDA had in the recent past detected cases related to violation of Drugs and Cosmetics Act like dispensing Schedule H drugs without prescription by unqualified persons to the patients, not having proper purchase and sale bill..
During the workshops, the pharmacists are sensitised on how to store the drugs at appropriate temperature at clean place away from direct sunlight. It is 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.
Workshops also give information on laws governing drugs like Drugs and Cosmetics Act, 1940 and Rules, 1945, Drugs Price Control Order (DPCO), 2013, Narcotic Drugs and Psychotropic Substances Act, 1985 and Rules 1985, Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules 1955 and Poisons Act 1919 and Rules thereunder
Other laws related to pharmacy profession are also discussed during the workshops like Pharmacy Act 1956, Pharmacy Practice Regulations 2015, Code of ethics and laws related with business and profession.
Good pharmaceutical practice stipulates 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.
Under the present rules, 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 should be stamped with the name, address and date of the supplier. Schedule X or narcotic drugs should be stored under lock and key arrangement.