In a formal communication to Union Minister of State for Health and Family Welfare Anupriya Patel, the All-India Organisation of Chemists and Druggists (AIOCD) has recently expressed deep concern over the rampant and unlawful operation of online pharmacy platforms across the country. The organisation did not mince words to express its displeasure over the alarming lack of action by State Licensing Authorities against the illegal activities of e-pharmacies despite repeated complaints being forwarded to them by the Central Drugs Standard Control Organisation. The AIOCD brought to the notice of the minister that the e-pharmacies continue to engage in sale of medicines in contravention to the D&C Act, 1940, thereby posing a severe threat to public health. The AIOCD is all the more concerned over the sale of even the habit-forming and psychotropic drugs through the e-pharmacies without requisite prescriptions from qualified doctors. The AIOCD also brought to the notice of the minister about the illicit dispensing of Schedule H, H1, and X medicines by the e-pharmacies in clear violation of existing laws, and the circulation of untraceable, diverted, and unlicensed stocks of drugs. As per the existing laws, Schedule H, H1, and X drugs are allowed to be sold by retailers under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist. Moreover, the AIOCD expressed concern over medicines being sold without any verifiable quality assurance or the necessary physical verification processes, raising serious questions about the safety and efficacy of these products. The organisation reiterated that medicines, unlike ordinary consumer goods, possess a unique and critical status that necessitates stringent oversight. Their sale and distribution, therefore, must not be relegated to automated platforms or operate through unauthorized logistics chains. The organization issued a warning that continued governmental inaction will inevitably lead to a public health disaster of ‘irreversible scale’.
Of course, there is some merit in AIOCD’s concerns as in the absence of exclusive and stringent laws, there is always the possibility of misuse of online platforms for distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications. Other concerns due to the lack of dedicated laws include potential lack of confidentiality, improper packaging, and intake of harmful drug interactions among several other issues. Obviously, a new set of rules for e-pharmacy is of much significance today as in the absence of clear-cut provisions in the D&C Act regarding the sale of drugs through e-pharmacies, utter confusion prevails in the country's pharmaceutical market at present. As the D&C Act does not distinguish between conventional and online sale of drugs, the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. It is not that the government is not seized of the issue. As the country's pharmaceutical trade started gradually moving from offline to online on the turn of last decade, the issue caught the attention of the regulators and the Union Health Ministry in July 2015 constituted an expert committee, under the chairmanship of then Maharashtra FDA Commissioner Dr Harshdeep Kamble, to assess the feasibility of online pharmacy in the country. After prolonged deliberations, the Ministry on August 28, 2018 came out with draft regulations to amend D&C Rules by incorporating separate part for the regulation of e-pharmacies in the country. Much water has flowed down the river since then, but the issue is still entangled in the bureaucratic circles of the Union Health Ministry. As the situation is getting murkier with the AIOCD literally on warpath, the government should shed its cavalier attitude on this serious issue which has been pending for almost a decade. |