For enforcing the Pharmacy Practice Regulations (PPR) 2015, the Drugs & Cosmetics Act and Rules must be amended in its favour by the Union government, says Dr Subhash C Mandal, chairman of the regulatory affairs division of the Indian Pharmaceutical Association (IPA).
He was responding to Pharmabiz from Kolkata on the ongoing dispute over carrying out inspections at medical stores by pharmacy inspectors in Kerala. According to him, the pharmacy inspectors must inspect the places where medicines are dispensed. For this purpose alone, the term ‘dispensing’ has been clearly defined in the PPR which was approved by the Union government and notified by the Pharmacy Council of India (PCI).
“The Pharmacy Practice Regulations 2015 were framed by Pharmacy Council of India and passed by the Parliament with a view to protect the health of the people of the country, and also to improve the profession of pharmacy practice in India. The traders oppose the regulations and hold agitations demanding to stop the council’s initiatives because of their business interest and profit making interest. The PCI and the state councils are concerned about the healthcare woes of the people, so they want to improve the pharmacy profession. For this, the new regulations have to be implemented,” said Dr. Mandal.
According to him, Pharmacy Practice Regulation 2015 is a historical regulation for protecting the health of the people. It is for improving pharmacy practice in India and the council has to implement it in the country. All the state councils have the right to inspect the pharmacies or places where drugs are dispensed. The PCI has introduced the regulations in exercise of the powers conferred by Section 10 and 18 of the Pharmacy Act, 1948.
The term ‘dispensing' is well defined in the PPR and it will help to ensure dispensing of medicines by registered pharmacists only. ‘Dispensing’ means the interpretation, evaluation, supply and implementation of a prescription, drug order, including the preparation and delivery of a drug or device to a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
Likewise, the ‘pharmacy practice’ is defined as, interpretation, evaluation and implementation of medical orders, dispensing of prescriptions, drug orders.
It is learnt that while framing regulations for pharmacy profession, the PCI considered four primary factors; they are; to improve the quality of health care, to ensure maintenance of standard in the duties of pharmacists, to reduce healthcare costs and to inhibit criminal abuse of medicines. The regulations have been framed by laying down responsibilities of pharmacist towards patient and the public in general.
The medico-legal-consultant and former dean of the All India Institute of Medical Sciences, New Delhi, Dr M C Gupta has said the resistance by AKCDA to pharmacy inspectors’ inspections is baseless. The traders’ body is bound to follow the law. There is no need to discuss with the traders by Pharmacy Council before implementing a law.
Kerala Pharmacy Council’s inspection at the medical stores has become a bone of contention between the council and the traders body, AKCDA.