Central govt should come out with final rules to govern e-pharmacies

The inordinate delay in finalizing the 'Final Rules on E-pharmacy' by the government has brought a tussle-like situation between brick-and-mortar retail chemists and online pharmacy players to the fore. The tug of war between them has reached to such a pass that recently the association of the offline chemists and druggists has sought the intervention of the Prime Minister to rein in the operation of internet pharmacy until the government comes out with final rules to regulate e-pharmacies in the country.

In fact, experts in the field have been making a clarion call to the government to come out with the 'Final Rules on E-pharmacy', on which the government has been working for the several years. 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 the last decade, the issue caught the attention of the drug regulators in the country and the Union Health Ministry in July 2015 constituted an expert committee, under the chairmanship of the then Maharashtra Food and Drugs Administration (FDA) Commissioner Dr Harshdeep Kamble, to assess the feasibility of online pharmacy in the country.

After prolonged deliberations, the Union Health Ministry on August 28, 2018 came out with an extensive set of draft regulations to amend the Drugs and Cosmetics (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 health ministry.

A new set of rules for e-pharmacy is of much significance 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. The country currently 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. 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. But, according to reports, as the existing laws are vague on the issue, there are rampant sale of prescription drugs by the e-pharmacies in contravention to the prevailing laws.

Earlier, the Department related Parliamentary Standing Committee on Union Commerce Ministry had also recommended to the Indian government that the draft of the e-pharmacy rules, which the central government had published almost four years back, should be finalised and implemented at the earliest. The Committee, headed by Member of Parliament V Vijayasai Reddy, in a report on the promotion and regulation of e-commerce in India presented to the Chairman of Rajya Sabha on June 15 this year, added that a comprehensive guideline for the e-pharmacy or e-health platforms should be released by the government without further delay.

The members of the committee were earlier informed that the scope for e-commerce in the pharmaceutical industry is immense and if properly regulated, online pharmacies in India could prove beneficial to various stakeholders. However, there is a serious need for framing the laws within India, as the online pharmacy laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India.

In the absence of regulatory guidelines, there is always a threat and possibility for supplying illegal or unethical medicines or outdated, substituted, or counterfeit medications to the person who ordered the drug instead of the real medication. 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. The Committee, while appreciating the rise of e-commerce in the pharmacy and health sector, however expressed concern at the possible misuse of such avenues for distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications amid the absence of regulations.

Stringent regulation of the e-health and e-pharmacy sector is essential in view of the potential harm it can cause to the health of the end user in case of misuse. The Parliamentary Committee's concern is genuine. While the nation's e-pharmacy market is brimming with activity with the entry of billionaires like Jeff Bezos and Mukesh Ambani in the fledgling sector, the country presently does not have a regulatory mechanism for online sale of drugs. Given this background, the central government should come out with the final rules on e-pharmacy without wasting further time.

(The author is a freelance journalist with varied experience in different fields)