This article has been published in ETRetail.com under the section ReTales- Blogs by Retails Gurus
he current scenario in India relating to online sale of drugs continues to remain unclear because of a circular released last year, on December 30, 2015 , by the office of the Drugs Controller General of India (“DCGI”), which directs all State and Union Territory drug controllers of India to maintain strict vigilance on online sale of drugs and take action,in public health interest, against persons engaging in such sales in violation of the Drugs and Cosmetics Act, 1940 (“DCA”) and Drugs and Cosmetics Rules, 1945 (“DCR”). However, in the said circular, while holding that the provisions under the DCR must be complied with by both brick-and-mortar sale and online sale of drugs, the DCGI admitted that no clear differentiation has been made between the two types of sales under the DCR.
Nevertheless, the aforesaid DCGI circular is not only temporary in nature but also has a certain background to it which explains why it was issued in the first place. Based on several representations from stakeholders in regular pharmacy (like All India Association of Chemists and Druggists) as well as e-pharmacy (like Indian Internet Pharmacy Association) sectors, the Drugs Consultative Committee was formed under the DCA, which examined the issue regarding online sale of drugs and, after due deliberations, formed a 7-member sub-committee to examine the issue of its impact on public health and the provisions under the DCA and DCR. The said sub-committee invited various experts from the IT field, Medical Council of India, National enforcement and investigation agencies and the like, to express their views and also invited suggestions and comments from the public on the issue of online sale of drugs. The sub-committee is still involved in deliberations with various stakeholders and until the final report on the issue of online sale of drugs is made available to the public, the DCGIdecided, asa temporary safety measure, to issue a direction of firmwatchfulness on the online sale of drugs.
Another important development, which the e-pharmacy sector ought to watch out for, is the public interest litigation (PIL) filed by N. Ruthynamoorthy in the Madras High Court seeking a direction to central and state authorities to ban websites selling schedule drugs online in violation of the DCA and DCR as well as the aforesaid DCGI circular imposing strict vigilance in relation to the same.
As per the DCA, drugs specified under Schedules H, H1 and X of the DCR, arenot permitted to be sold except on a registered medical practitioner’s prescription. However, excluding prescription drugs specified under Schedules H, H1 and X of the DCR, there is a confusion on whether e-commerce players cansell over-the-counter (OTC)/non-prescription drugs listed in Schedule K of the DCR, because of certain conditions stipulated in Schedule K, which e-commerce players cannot meet.
It may be recalled that in May 2015 Maharashtra FDA filed an FIR against Snapdeal CEO Kunal Bahl and other directors for selling prescription drugs. Snapdeal was reportedly selling sildenafil citrate tablets (Viagra), that only urologists, psychiatrists, endocrinologists and dermatologists could prescribe. In addition the marketplace was also selling OTC emergency contraceptives. Currently, the company has removed all listings of products even remotely related to health and medicines. In the same month, the Gujarat FDA also raided Prowisor Pharma, a Surat-based online pharmacy.
Maharashtra FDA also took action against Flipkart, Snapdeal and Amazon last month in February, for selling drugs online without valid sales bill and requisite licenses.
In spite of all these negative developments, online pharmacies in India have significantly increased due to growing ecommerce in India. There are various online medicine retailers who are selling medicines following different models, including an aggregator model, where websites and apps do not directly sell drugs but merely connect local pharmacies to consumers and assist in faster delivery of drugs by permitting such consumers to upload their prescriptions online. An example of such a model is CareOnGo, a drug delivery app, which acts only as a medium for local pharmacies to distribute drugs and has recently raised USD 300,000 in its seed round of funding last month in February.
There are various players that are vying with each other to grab the largest piece of the $11.5 billion retail pharmacy pie, which is growing at a rate of 20% year-on-year . Startups like 1mg Ayush.com, Healthkart, BigChemist, Healthgenie, Healthadda, mChemist, Merapharmacy.com, Netmeds.com, Medidart.com and Deemark are some of the few names.
Online players have been able to offer better discounts to the customers and thus pose tough competition to even the large players in offline space. There are certain inherent dangers of online sale of medicines in a country like India, where spurious and counterfeit products are rampantly available. However, nobody can deny that there have been rampant violations in the offline space too. No medical store keeps a record of prescriptions. It is a fact that patients order drugs over telephone and neighborhood pharmacies deliver them, without even asking for prescriptions.
The e-commerce sector can only hope that in view of greater investments in the e-pharmacy sector and ultimate benefit to consumers by way of easier access to drugs at any time and with minimum hassles, the Indian government will introduce amendments to the DCA and DCR in order to facilitate online sale of drugs and be able to come up with an appropriate framework consisting of the right checks and balances in place to address the same.