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There are reports that the All India Organisation of Chemists and Druggists, representing over 10 lakh pharmacists across the country, is bracing up for a nationwide strike against online pharmacies, highlighting the detrimental impact of online pharmacies on the livelihood of brick-and-mortar chemists. The AIOCD is concerned over the fact that small and independent chemists are facing severe financial strain due to the predatory pricing strategies employed by the online pharmacies, including heavy discounts and bulk sales. The AIOCD is also concerned over the functioning of online pharmacies, citing violation of the D&C Act as it argues that online pharmacies contradict the principles of the D&C Act, which mandates proper prescription-based drug dispensing. The country presently does not have a regulatory mechanism for online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. The D&C Act does not distinguish between conventional and online sale of drugs and the unfolding situation has resulted in the verbal duel between the offline and online pharmacy associations. The AIOCD argues that as online pharmacies operate without proper monitoring by the medical fraternity, it poses a significant risk to the public health and this will lead to serious issues concerning patient safety, antimicrobial resistance, and regulatory oversight. It is not that the government is not aware of the development. As the country's pharmaceutical trade started gradually moving from offline to online on the turn of this 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 an extensive set of draft regulations to amend D&C Rules by incorporating separate part for the regulation of online pharmacies in the country. Ever since, the issue is entangled in the bureaucratic circles of the Ministry.
In the wake of rising protests from the brick-and-mortar chemists, a set of rules exclusively for governing the e-pharmacies in the country is of great significance today. 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 existing laws are vague on e-pharmacy, there are reports of rampant sale of prescription drugs by the e-pharmacies in contravention to the prevailing laws. As per Section 18 (c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for 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. Easy access to critical medicines like antibiotics through online pharmacies is a serious issue and there is definitely a need to have stringent and specific provisions for ensuring the effective monitoring and supervision on online pharmacies. In the context of rising incidence of multi-drug resistant bacteria, which is a serious public health issue worldwide, there is a larger public interest in regulating the online supply of drugs. Another issue that is also a cause for serious concern is that the new trading platform can also be used by the unscrupulous elements in the trade to route substandard and spurious medicines. The AIOCD has now recommended formation of a government committee with representation from AIOCD to draft policies for digital healthcare services, strict enforcement against unauthorized online sales and closure of e-pharmacies violating drug regulations. It has also recommended implementation of an e-prescription system to regulate digital drug dispensing. The Union Health Ministry should urgently intervene in the matter.
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