E-pharmacy rules: Clear regulatory direction needed

Concerned over the inordinate delay in finalizing the rules and regulations for the fledgling online pharmacy sector to control the online sale of medicines in the country, the Department-related Parliamentary Standing Committee on Commerce Ministry has recommended to the central government that the draft of the e-pharmacy rules the Union Health Ministry had published almost four years back should be finalised and implemented at the earliest.

The Parliamentary Committee, in its report on 'the promotion and regulation of e-commerce in India', which was presented to the Chairman of Rajya Sabha on June 15, stated that a comprehensive guideline for the e-pharmacy or e-health platforms should be released by the government without further delay.

Appalled over the fact that the draft e-pharmacy rules have not yet been finalized years after a high-powered committee was formed for the purpose, the Parliamentary Committee, chaired by Member of Parliament V Vijayasai Reddy, reiterated that undue delay in adopting a definitive regulatory framework will result in uncertainty which is not conducive for the fast pace digital markets.

The Committee, while appreciating the rise of e-commerce in the pharmacy and health sector, expressed concern at the possible misuse of such avenues for distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications amid the absence of regulations.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.

It is apparent 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.

It is clear that 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of regulatory guidelines, there is always a threat and possibility for supplying illegal or unethical medicines or outdated, substituted, or counterfeit medications to the person who ordered the drug instead of the real medication. There are other concerns also which include potential lack of confidentiality, improper packaging, and intake of harmful drug interactions among several other issues.

In such a backdrop, a comprehensive guideline that encompasses the due diligence measures should be undertaken by the e-pharmacy platforms; mandatory registration with the appropriate authority for sale of medicines should be done, assigning responsibility on such platforms for the sale of genuine medicines, regulating the sale of controlled drugs, etc. should be formulated in consultation with all the stakeholders.

It is now crystal clear that 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. And according to available data, the Indian e-pharmacy market, with around 50 e-pharmacies and accounted for 14 per cent share of the total revenue of e-pharmacies in the Asia Pacific Region in 2020, is expected to grow at a higher ACGR of around 40-45 per cent as compared to the global e-pharmacy markets that are expected to increase at a CAGR of around 15-20 per cent.

Besides, medicine spending in India is expected to grow between 9-12 per cent over the next five years. But unfortunately, 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 Drugs and Cosmetics Act (D&C Act) does not distinguish between conventional and online sale of medicines.

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 of the country. In the present circumstances of Covid-19 pandemic, when the people have been asked by the government as well as the medical fraternity to remain indoors, the relevance of e-pharmacy is much more significant.

But, in the absence of clear-cut provisions in the D&C Act regarding the sale of medicines through e-pharmacies, utter confusion prevails in the country's pharmaceutical market, which has resulted in the verbal duel between the offline and online pharmacy associations. This scenario should end. The government should not waste further time in finalizing the exclusive rules for the fledgling online pharmacy sector in India.

(The author is freelance journalist with varied experience

in different fields)