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The Drugs Controller General of India has recently issued a circular directing the state drug licensing authorities to examine a proposal to grant ‘restricted licenses’ to Primary Agricultural Credit Societies (PACS) to operationalize Pradhan Mantri Bhartiya Jan Aushadhi Kendras (PMBJK) in rural and tribal areas without the services of registered pharmacists where registered pharmacists are reportedly scarce. The proposal, originated from the Union Ministry of Cooperation, argued that the mandatory requirement of a full-time registered pharmacist is hindering the expansion of affordable medicine centres in remote regions. By invoking Rules 62A and 62B of the Drugs and Cosmetics Rules, 1945, the government is considering allowing PACS to operate these centres under Forms 20A and 21A. These specific licenses would permit the sale of certain drugs, primarily those not requiring professional supervision, without the supervision of a registered pharmacist. As per Section 18(c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 stipulates sale of drugs under the supervision of a registered pharmacist which also involves signing of the bill and stamping of the prescription by the pharmacist and the doctor. While issuing the circular in this regard, the government is arguing that there is shortage of registered pharmacists in the rural and tribal areas of the country. But, experts in the field and the pharmacy associations are vehemently challenging the government’s claim regarding the scarcity of professionals. They assert that India currently possesses a vast network of licensed pharmacies and an adequate number of registered pharmacists even in remote areas. They argue that the original intent of restricted licenses, designed for exceptional circumstances where no shops were available, is no longer justified given the current saturation of qualified pharmacy personnel across the country.
Obviously, the new directive from the DCGI has sparked intense debate within the pharmaceutical community. The All India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh members across the country, has raised serious concerns regarding the storage of drugs alongside poisonous substances as the PACS primarily handle fertilizers, pesticides, and agro-chemicals, posing a severe risk of cross-contamination. The organization has expressed the fear that storing medicines in such environments violates Good Storage Practices (GSP) and directly threatens patient safety, as pharmacological integrity could be compromised by chemical exposure. The organization warned that dispensing medicines through non-pharmacists would lead to a parallel unregulated drug distribution system in the country. It noted that such a move could exacerbate the national challenge of Antimicrobial Resistance (AMR) due to the potential for indiscriminate sale of antibiotics by untrained staff. Besides, the lack of professional supervision is expected to increase medication errors and the risk of misusing habit-forming drugs. Of course, the DCGI’s directive is in direct conflict with the Drugs and Cosmetics Act,1940 and Rule 65, which stipulates that retail drug sales must be conducted under personal supervision of a registered pharmacist. The new directive could water down and weaken both the Pharmacy Act and the Drugs and Cosmetics Act. While the initial change may seem small, it will set a dangerous precedent that could eventually extend to other sectors. Allowing medicine distribution in the cooperative agriculture sector without professional oversight will compromise the integrity of the entire healthcare system. The government should revisit its decision.
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