Last Updated on November 11, 2021 by The Health Master
The Union government has acknowledged the Karnataka State Registered Pharmacists Association (KSRPA)’s demand to permit licenses for Jan Aushadhi stores only to registered pharmacists.
In a reply, the Union ministries of health and family welfare and chemicals and fertilizers stated that the proposal has been forwarded for action.
This follows after the Association, in its communication to the Union government, indicated that the presence of a registered pharmacist was mandatory as he had the expertise to dispense the right drugs, advise on drug management and indicate adverse drug reactions.
The presence of a registered pharmacist is a must, and more so, Jan Aushadi stores are being set up under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), which requires them to strictly adhere to the regulations of the Drugs and Cosmetic Act.
Moreover, Jan Aushadi stores are dispensing generic drugs that are affordable and of high quality. These stores are frequented not just by the general population but also the economically weaker sections. Hence, there is every need to ensure that only registered pharmacists are issued licenses by the state drug control department, said Ashokswamy Heroor, president, KSRPA.
Noting that there are several Jan Aushadhi stores in the country that are managed and operated by non-pharmacists, Heroor viewed this as a gross violation of the regulations. According to him, any dedicated outlet dispensing drugs needs to have the presence of a registered pharmacist.
Every pharmacy trade fraternity ensured having a pharmacist to dispense drugs. Therefore, when granting licenses to the Jan Aushadi stores, their proprietor and managing partner should be registered pharmacists. This would be in sync with the prevailing practice norms for pharmacy trade outlets in the country.
DTAB: In an earlier communication to the government regarding Jan Aushadi stores, KSRPA president pointed out that permitting only these outlets to substitute drugs amounts to discrimination. Referring to the Drugs Technical Advisory Board (DTAB)’s 81st meeting on November 29, 2018, he said, “DTAB has deliberated on the proposal of allowing drug substitution for Jan Aushadhi stores under the Drugs and Cosmetic Rules.”
Rule 65 (11A): It agreed to amend Rule 65 (11A) to allow drug substitution specified in Schedule H, Schedule H1 and Schedule X with drugs containing the same substance, strength and dosage. This is because generic drugs need to be not just affordable but of high quality.”
However a draft notification in this regard for necessary amendments in the Drugs & Cosmetic Rules was pending and yet to be issued, said Heroor.
According to Heroor, the KSRPA communication being acknowledged by the government is a major development as it has taken cognizance of these views to ensure registered pharmacists dispense drugs at Jan Aushadi outlets.
Further, he also hopes that the government will amend rules to substitute drugs for all pharmacy trade outlets, including Jan Aushadi Kendras. “What is now being opposed is that the government is working to amend rules for drug substitution only for Jan Aushadi Kendras,” said Heroor.
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