Legal Hassles With Online Pharmacies

In May 2015, Maharashtra’s Food and Drug Administration (FDA) filed a First Information Report (FIR) against Snapdeal Chief Executive Kunal Bahl and the company’s directors, in connection with the sale of prescription drugs online. That’s when the concept of online pharmacy came into light. With more customers willing to shop online for just about anything, and smartphones facilitating such transactions, the medium is just right for selling drugs online. Though it is still at a nascent stage yet it promises growth.

What makes online pharmacies so controversial?

In the Indian market, to sell medicines and drugs, there are certain guidelines and rules which are to be followed otherwise stringent punishments in the form of imprisonment or monetary penalties may be awarded. According to the Indian Pharmacy Act, 1948 section 42(1), “No person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner” Moreover, Section 18(c) of the Drugs & Cosmetics Act also prohibits manufacture and sale of any drug without a license. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have clear guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can be sold only on the prescription of a registered medication practitioner. They also require meticulous storage and dispensing records.

Moreover, Drugs and Cosmetics Act has various provisions prohibiting the import of any drug that is not of standard quality, any misbranded, adulterated or spurious drug or any drug for requires a license for import. It also does not permit import of “any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or alleviate any disease.” Imported medicines may be fake, mislabeled and unsafe.

While over the counter products can be sold even without prescriptions, many e-commerce companies following the marketplace model are selling even prescription drugs online.

Without obtaining any license and without any prescription, providing the medicines within the reach of everyone can have grave consequences. The Indian Pharmacy Act does not give clarity on this. However, the IT Act says that any digital copy of a document will be valid if there is an original copy which can be presented at the time of verification.

To look into the matter and bring out guidelines relating to it, Drugs Consultative Committee (DCC) has constituted a seven-member subcommittee to examine the issue of the online sale of drugs, while taking care of the risks and concerns related to such sales.

In an interview highlighting the need for the online pharmacy, G.N. Singh, Drug Controller General of India (DCGI) said, “We are very clear on this issue; we want this technology in the country because our aim is to ensure that patients get quick service and of the right quality. We want to see how the issue can be addressed without compromising on safety. There are chances of abuse of technology as well that we want to plug.” In an attempt to level the playing field, the DCGI issued a fresh circular on 30 December saying that, “the rules do not distinguish between the conventional and over the Internet sale of drugs”. However, there will be a “strict vigil” on the online sale of medicines and action would be taken against companies if they are found to be in breach of regulations.

So how can online pharmacies overcome these hurdles?

While it is true, internet offered the opportunity to escape jurisdictions, online businesses should be aware that, precisely because of the borderless nature of the internet, they are potentially exposed to more, not less, public or private competition law enforcement. So, any law that is applicable to the traditional sale of drugs through shops and by way of licenses have to still be complied with.

It is true that online markets are here to stay and for the customers to reap maximum benefits, the e-commerce websites and the government have to work in tandem with each other. Adequate checks and balances may be put in place to prevent the sale of any Schedule X drugs. A team of qualified pharmacists and pharmacologists for validation of prescriptions could be one of the options through which is it ensured that no banned or unsafe drugs are sold online. In addition, the online market players need to ensure that the required laws are complied with so that there is no scope for any ambiguity and maximum customer satisfaction is achieved.