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Follow The DCGI Directive

Ramesh Shankar
Wednesday, April 5, 2023, 08:00 Hrs  [IST]

The Drugs Controller General of India (DCGI) has recently written to drug controllers of all States and Union Territories and also to the Pharmacy Council of India asking them to ensure that pharmacists are physically present in retail medical stores and also directed that medicines should be sold only under direct supervision of pharmacists in retail medical stores. In a letter, DCGI Dr Rajeev Singh Raghuvanshi sought strict implementation of Section 42(a) of the Pharmacy Act and Rules 65 of the Drugs and Cosmetics Act in retail pharmacies. The DCGI’s directive is very relevant as it is a fact that a significant number of retail stores are being operated by non-pharmacists who take the pharmacy certificate on rent from graduates in this discipline. If reports are to be believed, one can get a pharmacy certificate in states like Bihar, Uttar Pradesh, Chhatisgarh, Jharkhand, Punjab, Rajasthan, Haryana, Telangana, etc for annual fees ranging from Rs. 15,000 to Rs. 70,000. As per Drugs and Cosmetics 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. He/she can function only at one place at a time. But the fact remains 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.

There can be no two opinions about the fact that a pharmacist is a vital link in the physician-patient chain and he is expected to play a key role in the dissemination of pharmaceutical knowledge. In India, although pharmaceutical industry has advanced over the last more than four decades, the pharmacist continues to be a salesman in a retail pharmacy. In the international level, the duty of a pharmacist is fast evolving from a mere dispenser of medicines in a retail medical store. Checking drug dosage, drug-drug interactions, drug-allergy interactions, drug food interactions, patient counseling, etc are all now becoming part and parcel of a pharmacist's job. It was under this background, the Pharmacy Practice Regulations (PPR) was notified by the Central government way back in 2015. One of the main purposes of this regulation was 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 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 or an unqualified person. 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 will play a key role in removing this corrupt practice across the country.


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