Last Updated on December 30, 2023 by The Health Master
The Indian Pharmaceutical Association (IPA) wanted the union health ministry to ramp up efforts to implement Section 42 (1) of the Pharmacy Act 1948 and Rule 65 of the Drugs and Cosmetics Rules 1945 in the pharma trade sector without further delay.
42(1) reads: On or after such date as the State Government may be notification in the Official
Gazette appoint in this behalf, no person other than a registered pharmacist shall
compound, prepare, mix, or dispense any medicine on the prescription of a medical
practitioner
The association believes that once this legislation and associated regulations are in place, a person will not be able to obtain a prescription-only drug without a registered pharmacist first reviewing it.
Further, it will become mandatory that medicines have to be purchased after careful monitoring by a qualified and approved dispenser.
Members of the IPA who are pharmacists-cum-traders believe that these provisions can be used as a powerful tool to stop the advancement of the e-pharmacy groups from expanding their operations throughout India.
IPA, the first organization of pharmacy professionals to be founded in India, has asked the Government of India to strictly monitor the purchase, sale, and dispensing of medications by pharma traders and to ensure that the drugs are reaching end users through licensed pharmacists. This is done to demonstrate its allegiance to the traders.
The association informs the secretary to the government that it is high time the government introduced the laws strictly on the lines of the drug policies implemented by the developed countries.
Globally, IPA reiterates, pharmacists are responsible for reviewing the prescriptions for any potential drug-related problem and appropriately dispensing medicines after proper counseling. They want the government to implement the system in India also without any delay.
In a letter to the secretary of the Government of India (Health), with a copy to the DCGI, IPA asserts that operating a pharmacy without a registered pharmacist and selling prescription drugs (Schedule H/H1) without a valid prescription are both highly illegal and harmful to one’s health.
Schedule-H: List of drugs falls under Schedule-H
Schedule-H1: List of drugs falls under Schedule H1
Schedule-H2: List of 300 drugs falls under Schedule H2 for printing Bar Code or QR Code
The association alleges that this kind of sale of scheduled drugs is happening only in India which is popularly known as the ‘pharmacy of the world’.
IPA wants the government to make India a model country in the management of medicines so as to enable other nations to follow our path.
According to association sources, dispensing medications on any prescription is required to be done in the physical presence of a registered pharmacist per Section 42(a) of the Pharmacy Act.
The Act is in force from 1948 and it was further bolstered by the amendment of Rule 65 of the D&C Act 1945 in the same year. Despite the introduction of all these acts and rules, medicines are sold through the retail pharmacies by unqualified pharmacists though the sale licences are issued on registered pharmacists.
According to IPA, no proper supervision by qualified pharmacists is held at the community pharmacies even on the sale of controlled drugs.
The IPA has informed the government that the country currently has a surplus of qualified pharmacists, far exceeding the required number.
So the government can easily implement the laws for sale of drugs under supervision of registered pharmacists through retail pharmacies. Pharmacies are the place where pharmacists are working and medicines are stocked and sold.
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