E-pharmacy regulation is being discussed by ministers as the industry grows by leaps and bounds in India.
The sector, which accounts for between two and three percent of the US$20 billion pharma market in India at present, is expected to grow sevenfold by 2022 when it is expected to be valued at US$3.7 billion compared to US$0.7 billion at present. This is according to projections by international investment firm CLSA Ltd.. The pharma market as a whole, currently valued at US$20 billion, is anticipated to grow to US$35 billion by 2025.
With the growth of the sector in mind, e-pharmacy regulation is being deliberated by a group of ministers (GoM) led by Union Defence Minister Rajnath Singh and also including Minister of Health and Family Welfare Dr Harsh Vardhan, Minister of Commerce and Industry Piyush Goyal, and Minister of Jal Shakti Gajendra Singh Shekhawat. Their meetings, the first of which took place on October 30th, aim to put an end to the lack of clarity surrounding e-pharmacy regulation which has dogged the industry for some time.
In December last year, a blanket ban on e-pharmacy sales was imposed following separate rulings by the Madras High Court and the Delhi High Court until clear regulations were set forth by the Centre. A deadline of January 31st was set for this to be done. Days later, the Madras High Court stayed the ban following an appeal by the industry, who feared losses of Rs 300 crore (US$42.77 million) as a consequence of the ban.
In the months since, the Union Health Ministry proposed a number of rules to regulate the sector. They would mandate that online medicines retailers be registered with the Centre, retain prescriptions, and corroborate details of both patients and practitioners to avert misuse.
However, the e-pharmacy sector has faced much opposition from pharmacies – sufficiently enough that the BJP government was unable to meet its targets of passing e-pharmacy regulation within its first 100 days after winning this year’s Lok Sabha elections. This was despite the proposals securing the approval of the Drugs Consultative Committee and the Drugs and Technical Advisory Board.
“The pressure from the offline chemists lobby — the All India Organisation of Chemists and Druggists (AIOCD) — is severe,” a senior Union Health Ministry official commented at the beginning of October, describing the AIOCD as “a powerful lobby of over 8.5 lakh chemist outlets.” On e-pharmacy regulation, the official said, “the final call will now come from the GoM. The issue is critical…It is about the availability of medicines in the market and consensus of stakeholders is important. The ministers will now decide how to go ahead.”