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E-commerce has greatly eased our life with almost everything available online, the comfort of buying things with just one click, and getting them delivered on your doorsteps. The current COVID-19 pandemic has added feathers to the already growing E-commerce. This increasing popularity of E-commerce has led to the emergence of E-pharmacies. E-pharmacies are the virtual platforms through which one can order the required medicines or drugs and get them delivered to their desired location. The availability of medicines on fingertips terminates the need of going to brick and mortar pharmacy. Non-prescription (OTC) medicines can be ordered directly, whereas, for the prescribed medicines, it is required to upload a scanned copy of an original prescription.
E-pharmacies have mainly three business models. First isbthe marketplace model, where the E-pharmacy acts as a platform and an intermediary and connects the customer to a physical pharmacy. Second, the inventory model, where the E-pharmacy possesses the drugs itself and sells them to customers directly through its own website/app. Third, a hybrid of both. Some of the prominent E-pharmacies are Netmeds, 1mg, Medlife, Pharmeasy, etc.
BENEFITS OF E-PHARMACIES
As online shopping comes with many benefits, E-pharmacies also have their benefits.
1. E-pharmacies are convenient and accessible for the customers as they can order medicines from their homes anytime and get them delivered on their doorsteps.
2. As E-pharmacies can be accessed from anywhere, the rural and remote areas with limited presence of physical pharmacies can avail this facility and can get medicines easily.
3. E-pharmacy sites are well developed, where they provide other information relating to every drug like drug interactions, side-effects, and warnings. These sites also have automated medicine reminders to improve compliance by customers.
4. Since online transactions on E-pharmacies can be tracked with complete details of the medicines, batch number, and details of retail pharmacy, prescribing doctor and the customer, any misuse, drug abuse, and overconsumption can be prevented.
RISKS ASSOCIATED WITH E-PHARMACIES
Along with the benefits attached with them, E-pharmacies have some risks associated with them, which are:-
1. E-pharmacies provide prescribed drugs when a scanned copy of the prescription is uploaded. Since, these are easy to manipulate, resulting in overuse of drugs.
2. Sensitive and health-related information of the customer gets stored online with these sites, at risk of privacy rights being violated. This personal data may get leaked or misused.
3. There can be the presence of illegal E-pharmacies, where customers will be at risk of getting low-quality and inappropriate drugs that can affect their health adversely.
4. Mishandling or carelessness during transportation can affect the drugs’ efficiency and potency.
5. Some drugs require specific storage conditions and if not monitored properly, sensitive drugs may lose their efficacy and potency.
EXISTING LEGISLATIONS FOR REGULATION OF E-PHARMACIES
In India, the manufacture, sale, and distribution of drugs is governed by the Drugs and Cosmetics Act, 1940 (‘DCA’), Drugs and Cosmetics Rules, 1945 (‘DCR’), Pharmacy Act, 1948, Pharmacy Practice Regulations, 2015 and the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954.
The DCA and DCR do not contain any provisions in relation to the online sale of medicines. But, a notice was issued by the Office of Drugs Controller General in 2015 to all state and union territory drug controllers stating that the provisions of DCA and DCR will be applicable on both conventional and online sale of drugs, therefore the provisions of the said rules need to be complied in both online and offline sale of drugs. Essentially, the notice paved way for the issuing of licenses for e-pharmacies as well.
The provisions and rules of the IT Act along with The Consumer Protection (E-Commerce) Rules, 2020 (“E-Commerce Rules”) are applicable to E-pharmacies and their portal.
The Delhi High Court in the case of Zaheer Ahmed v. Union of India banned the online sale of medicines without a valid license. Further, in an official letter dated November 28, 2019, the Drugs Controller General of India (DCGI) issued a notification to all drug Controllers to enforce this order of the Delhi High Court.
In totality, there is no exhaustive and particular legislation to regulate the E-pharmacies in India. currently, different provisions from various legislations are interpreted and used for regulation. Although, draft Drugs and Cosmetics (Amendment) Rules, 2018 (“Draft E-Pharmacy Rules”), the same are not notified and enforced yet.
SOME KEY ASPECTS OF DRAFT E-PHARMACY RULES
The draft rules contain some provisions for regulations, which are:-
1. Registration is mandatory for any person who wishes to run an E-pharmacy. The registration will be valid for 3 years and can be renewed.
2. Addressing the privacy issue, the draft rules says that the personal information of the customer is to be kept confidential and should not be disclosed or shared. However, it can be shared with the Central or state government for public health purposes. Also, the health data must be stored locally i.e. it cannot be stored or sent outside India.
3. The rules prohibit the selling of those drugs mentioned under the Narcotic Drugs and Psychotropic Substances Act, 1985 (habit-forming drugs), tranquilisers, and Schedule X drugs.
4. The E-pharmacy must provide customer service and grievance resolution facility 24/7. There should also be a registered pharmacist to answer the queries of customers.
5. The premises from where the E-pharmacy business is conducted shall be inspected every 2 years by the Central or State Licensing Authority.
The draft is still not exhaustive and lacks in addressing some issues like validity of prescriptions, misuse of prescriptions, dispensing of prescription drugs, operation of illegal pharmacies, storage and transport, and the issue of multiple licensing. There is a need for legislation that caters to all the issues relating to E-pharmacies and the framed draft rules need some more additions.
In the current situation of the COVID-19 pandemic, there is an all-time high demand for E-pharmacies owing to travel restrictions and fear. With the ever-increasing reliance on online shopping, people should be protected against the risks associated with it. Customers should have a proper framework and legislation so that they can hold the E-pharmacies accountable for violation of any rules. Proper and exhaustive legislation is the need of the hour.
As the world is facing a severe health crisis, it becomes of far more importance to have legislation on something which can gravely affect customer’s health if not regulated. It is high time for the government to come up with strong and effective regulations to look after E-pharmacies. Encompassing and addressing all the issues in the current draft E-pharmacy rules and bringing them into force as soon as possible is an urgent need currently.
 Writ Petition (Civil) No. 11711 of 2018