The home delivery of medicines has become a necessity especially during the when everyone is staying safe at their own homes. Do Indian laws permit the delivery of medicine at your doorstep? Is the functioning of online pharmacies adequately regulated in India? How have various courts dealt with the regulation of online pharmacies? The primary legislation which govern the sale of drugs is Drugs and Cosmetics Act 1945 (“DCA”) and its related rules. Section 18(c) of DCA read together with Rule 65 of Drugs and Cosmetics Rules 1945(‘DCR”) prohibits the manufacturing, distributing, selling, stocking, exhibiting of any drug unless an appropriate license in accordance with the conditions given under DCA is obtained.
DCA does not contain a separate provision for the online sale of drugs and therefore it can be construed that the license to sell under Rule 65 of DCR has to be procured from the licensing authority for the online sale of medicines too. However, the internet-based platforms which facilitates the sale of medicines take aegis under Information Technology Act 2000(IT Act) and have viewed themselves as they coordinate between the customers and pharmacies, and thereby an intermediary network service provider. Under section 79 of IT Act, these intermediaries are protected from any liability, for any third-party information or data made available by them.
Draft Rules with respect to E-Pharmacy
With respect to the regulation of sale of drugs through e-pharmacies in India, the Ministry of Health and Family Welfare (MoHFW) issued draft rules in relation to sale of drugs by e-pharmacy (“Draft Rules”) vide a notification dated 28th August 2018. This Draft Rules proposes a regulatory framework for any business of distribution, sale stock, exhibit or offer for sale of drugs through web portal or any other electronic mode. It mandates the registration of e-pharmacy in accordance with the procedure laid down in the e-pharmacy rules. The Draft Rules envisage delivery of medicines through online web portal or any such electronic mode only against a prescription by a Registered Medical Practitioner (RMP), and also require compliance of privacy and data protection under IT Act. However, the rules have so far remained in draft form and is yet to be notified as an amendment to the DCR by MoHFW.
Disputes and decisions
With many e-pharmacies doing business, led to few disputes by way of writ petitions arraying the government and the e-pharmacies. One such writ petition was filed by Association of Tamil Nadu Chemists and Druggists [Tamil Nadu Chemists and Druggists Association v. Union of India and Ors (WP/28716/2018) decided on 17th December 2018] for blocking the link of websites from India which is engaged in the sale of Schedule H, H-1 and Schedule X drugs in violation of Rule 65 and 97 of DCR. The petitioner contended that the online platforms continue to sell medicines through web portal even though the regulation is not passed by the Central Government. Further, the petitioner contends that the online sale of medicines would defeat the purpose of the DCA which regulates the quality and availability of drugs through prescribed pharmacists. The recalling of drugs, if it is found to have side effects, may not be possible in case of online sale of medicines as tracing the movement of medicines is difficult. The Hon’ble Madras High Court directed on 17th December 2018, the Central Government to notify the proposed amendment rules with respect to sale of drugs through e-pharmacy at the earliest not later that 31st January 2019 and also held that online portals are bound not to proceed with the online business of sale of drugs till the amended rules are published and the appropriate license is procured. However, an order was passed by Hon’ble Madras High Court on 20th December 2019 lifting of the ban of online sale of medicines till further orders.
Similarly, a writ petition was filed in the Hon’ble Delhi High Court by a dermatologist, Dr. Zaheer Ahmed [Dr. Zaheer Ahmed vs. Union of India & Ors ] against the online sale of medicines contending that it violated the provisions of DCA. The Hon’ble Delhi Court banned the sale of medicines online and also advised Central Government to pass the amendment rules with regard to the e-pharmacy. Pursuant to injunction order by Hon’ble High Court, the Drug Controller General of India (DCGI), through a letter dated 28th December 2018 instructed all the state regulators to ban online drug sales operating without license.
In these two judgements, the both the courts highlight the need of the Draft Rules to be notified.
Recent Notification by MoHFW on Doorstep Delivery of Medicines
Post the announcement of lockdown in March 2020, MoHFW by notification dated 28th March 2020, allowed the sale of drugs including the drugs specified in Schedule H, Schedule H1 and Schedule X (except narcotics, psychotropic and controlled substances as defined in Narcotics Drugs and Psychotropic Substances Act 1985) delivery at doorstep by any person holding a license in Form 20 (drugs other than those in Sch. C, C(1) & X), or Form 21 (drugs other than those in Schedule X) of DCA. The notification places the following conditions for delivery of Schedule H:
a. The sale to be effected based on the receipt of prescription physically or through an e-mail;
b. The license holder to submit the email id for registration with licensing authority of prescriptions are to be received through email;
c. The drugs to be supplied at the doorstep where the patient is located within the same revenue district where the licensee is located;
d. In case of chronic diseases, the medicine is to be dispensed only if it is presented to the license holder within 30 days of the date of prescription, and in acute cases, the medicine is to be dispensed only if it is presented to the license holder with 7 days of its issue;
e. The bill or cash memo shall be sent by return email and records of all such transactions shall be maintained by the license holder.
It is clear that the notification dated 28th March 2020 by MoHFW, which permits the delivery of medicines at home, helps to improve the business of a pharmacist who has a physical medical store and holds a valid license to sell the drugs. However, this notification does not contain any regulation on the intermediary web portals/platforms which provide the online sale and delivery of medicines. The need of the hour is the passing of the amendment rules to DCA in relation to the sale of medicines via e-pharmacy to regulate the intermediary service providers. A regulated e-pharmacy system would help in the smooth delivery of medicines to the needy at the right times and would also adequately complement the telemedicine practice recommended by the Medical Council of India.