The Karnataka drugs control department has said that sale licenses were issued to Pradhan Mantri Bhartiya Jan Aushadhi Kendras (PMBJAK) only after ascertaining that they were manned by qualified and registered pharmacists.
The department has noted that out of its total 709 Jan Aushadhi outlets across the 30 districts in the state, 85 are owned by registered pharmacists. The remaining 624 outlets have appointed registered pharmacists to man the operations on a day-to-day basis and shared details with the state regulatory authority when seeking license.
The department has categorically stated that no licenses have been granted in cases where there is no presence of a registered pharmacist. Moreover, these Jan Aushadhi outlets have inked a formal agreement with the Bureau of Pharma PSUs of India (BPPI) which has now issued guidelines for opening new PMBJKs.
Licenses are granted as per the norms stipulated under Rule 64 of the Drugs & Cosmetics Act. These outlets dispense generic drugs based on the prescriptions, BT Khanapure, drugs controller, government of Karnataka told Pharmabiz.
If any violations are spotted by the enforcement teams, action will be taken as per the Drugs & Cosmetics Act, and no one will be spared, he added.
Similarly, the licensing rules that govern Jan Aushadhi outlets also apply to government hospitals and primary health centre pharmacies. Under no circumstances can a non-pharmacist dispense medicines at these counters. It is only a qualified and registered pharmacist who has the knowledge to dispense the prescribed drugs and advise patients who is allowed to run these pharmacies.
We have sent these details to the Drugs Controller General of India. Our department has been known for regular surprise inspections across retail pharmacy outlets and those operating within hospital facilities. The generic drugs dispensed at these outlets are picked up at random and tested to assess the quality too, he said.
In August this year, the Union government had announced it had doubled the financial support from Rs. 2.50 lakh to Rs 5 lakh to expand the number of PMBJAK from the current 6,500 in 732 districts to 10,500 to provide employment opportunities to qualified pharmacists during the ongoing COVID-19.
The government, in its announcement, indicated that any non-government organization, cooperative society, unemployed pharmacist and medical practitioner could open these stores and mandated that they have to be manned by registered pharmacists and the shops should be set up on an area of 120 sq. ft.
Further, BPPI has also communicated with all state licensing authorities to approve the outlets as per the norms of the Drugs & Cosmetics Act, said the Karnataka drugs controller Khanapure, adding that it has apprised the Drugs Controller of General of India about the norms being followed at all the existing Jan Aushadhi outlets in the state