DCGI should mandate presence of pharmacists in every retail medical store

The presence of pharmacists for dispensing of medicines under their direct supervision in retail medical stores across the country has been a major issue being faced by drug authorities for a long time now. Though the focus of pharmacy practice in developed countries has shifted from product-centric to patient-centric with the implementation of modified pharmacy practice regulations favouring patient safety, in India, it is a fact that a significant number of retail stores are still being operated by non-pharmacists who take on rent pharmacy diplomas and degrees from graduates in this discipline.

According to reports, one can get a pharmacy certificate in Bihar, Uttar Pradesh, Chhattisgarh, Jharkhand, Punjab, Rajasthan, Haryana and Telangana against an annual fees ranging from Rs. 15,000 to Rs. 70,000.

As per the D&C Act, retail stores cannot dispense drugs in the absence of a registered pharmacist. It is highly unethical for a registered pharmacist to lend his or her registration to any other person. The individual can function only at one place at a time. In spite of the law mandating presence of pharmacists for dispensing of medicines, non-pharmacists continue to operate medical shops with rented certificates. This scenario should change as the focus of pharmacy practice in India too is gradually shifting from being product-centric to patient-centric. It is a fact that even though the pharmaceutical industry has witnessed phenomenal growth over the last four decades, the pharmacist continues to be a salesman in a retail pharmacy. Pharmacists are mostly seen by the public in the country as salesmen handing over medicines at the retail shops prescribed by physicians.

There has been a paradigm shift in the duties of a pharmacist in the entire world. And India is no exception. It was especially evident during the Covid-19 pandemic. Braving all the risks associated with this highly infectious disease, the pharmacist community rendered yeoman’s service to Covid patients. At the international level, the duty of a pharmacist is fast evolving from that of being a mere dispenser of medicines in a retail medical store. Checking drug dosage, drug-drug interactions, drug-allergy interactions, drug food interactions and patient counseling are all now becoming part and parcel of a pharmacist's job. Pharmacists of today are expected to interact with patients, doctors and nurses in a collaborative model as is the case with the developed countries.

In the US, UK, Canada, New Zealand, Portugal, Ireland and even Ethiopia, clinical pharmacists are an integral part of the healthcare system and work along with physicians and nurses.

Against this backdrop, the recent directive of the Drugs Controller General of India (DCGI) holds much significance. The DCGI directed drug controllers of all States and Union Territories and the national pharmacy education regulator the Pharmacy Council of India (PCI) to ensure that pharmacists are physically present in retail stores and medicines should be only be sold under their direct supervision.

In a letter, DCGI Dr. Rajeev Singh Raghuvanshi sought strict implementation of Section 42(a) of the Pharmacy Act and Rule 65 of the Drugs and Cosmetics Act in retail pharmacies. The directive is timely and relevant as a significant number of retail stores are being operated by non-pharmacists. This scenario should end.

It is true that the government has come out with the right kind of regulation, but it has not taken steps to implement it in letter and spirit. The Pharmacy Practice Regulations, 2015 is a case in point. One of the main purposes of this regulation was to curb the malpractices prevailing in drug stores and thereby enhancing the status and practice of pharmacy profession in the country.

The intention of PPR 2015 was to lay down a uniform code of pharmacy ethics, responsibilities of pharmacists towards patients and the role of a community pharmacist. Another key provision is to empower all state pharmacy councils to appoint pharmacy inspectors in all districts. As per the provisions of PPR, pharmacy inspectors are authorized to inspect retail outlets and ensure that medicines are dispensed by a qualified pharmacist and not by an unqualified person.

It is time to bring in sweeping changes so that the image of pharmacists as mere dispensers is not struck. The DCGI, albeit belated, has set the ball rolling.