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The country’s pharmacy education regulator, the Pharmacy Council of India (PCI) has recently directed all the State and Union Territory (UT) governments and State Pharmacy Councils to take immediate steps to implement the Pharmacy Practice Regulations (PPR), 2015, notified by the Council in January, 2015. The PCI’s directive comes in the wake of a letter from the Union Health Ministry clarifying the procedures for implementation of PPR in the States as the education is in the Concurrent List of the Indian Constitution. Based on this communication, the PCI has now sought all State governments to immediately implement the PPR, 2015. The regulation lays norms including the code of pharmacy ethics, duties and responsibilities of the registered pharmacists, maintaining good pharmacy practices, maintenance of patient records, duties of registered pharmacists to their patients including promotion of rational use of drugs, definition of unethical acts, and punishment and disciplinary action in case of violation of the conduct. The PPR-2015 also details how a pharmacist can provide patient counselling. Under the Regulation, a registered pharmacist is required to dispense medicines on the prescription of a Registered Medical Practitioner and can counsel the patient or caregiver on medicine to enhance or optimize drug therapy. The elements of patient counselling include providing information on the name and description of the drugs; the dosage form, dose, route of administration, and duration of drug therapy; intended use of the drug and expected action; special directions and precautions for the drug; common, severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur; techniques for self monitoring drug therapy; proper storage of drugs; prescription refill information; action to be taken in the event of a missed dose; and ensuring rational use of drugs.
To curb the malpractices prevailing in the lakhs of drug stores and thereby enhancing the status and practice of pharmacy profession in the country, the Pharmacy Practice Regulations (PPR) was notified by the Central government in 2015. Till then, the pharmacy profession was regulated by two statutes namely the Pharmacy Act and the Drugs & Cosmetics Act. The intention of PPR-2015 was to lay down a uniform code of pharmacy ethics, responsibilities of pharmacists towards patients, role of a community pharmacist, etc. Another key provision in the PPR was to empower the state pharmacy councils to appoint pharmacy inspectors in all the districts of every state in the country. As per the provisions of PPR, pharmacy inspectors are authorized to inspect the retail outlets for checking whether medicines are dispensed by a qualified pharmacist. Currently, drug inspectors of the state drug control departments are conducting such inspections at the retail outlets. But the inspections of pharmacy outlets, especially in rural areas, by the drug inspectors have been far and few between, thanks to the perennial issue of shortage of manpower in the state drug control departments. In such a situation, appointment of pharmacy inspectors as laid down in the PPR would have gone a long way to ensure that only qualified pharmacists dispense medicines in all the retail outlets. In a country where certificate-lending is rampant, the appointment of pharmacy inspectors in every district as laid down in the PPR would have played a key role in removing this corrupt practice across the country. Unfortunately, though it is more than six years since the regulation was notified, it remained largely on paper as only some states have implemented it so far. It is highly unethical for a registered pharmacist to lend his or her registration to any other person. He/she can function only at one place at a time. But non-pharmacists continue to operate medical shops with rented certificates of pharmacists. This scenario should change as the focus of pharmacy practice in India too is gradually shifting from product centric to patient centric. It is definitely a welcome step by the PCI. Now, it is over to the state governments and state pharmacy councils to act.
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