With the spurt in internet and e-commerce in the last few years, the need for effective governance of e-pharmacies was overdue.
In view of this, the Central Government has circulated the much-awaited new set of draft rules relating to the e-pharmacies (online pharmacies) to States seeking their opinion thereon.
The objective of the draft rules is to ensure that the patients are able to procure genuine medicines from genuine and duly authenticated e-pharmacies.
Another prospect of the draft rules is to impose strict conditions to facilitate e-pharmacies to conduct their online business without much fuss as well as incorporating strong penal provisions to punish those found violating the rules.
Glimpse of key provisions of the draft rules related to e-pharmacies:
· As per the draft rules, e-pharmacies will be obligated to obtain all India license permit from the Drug Controller General of India (Apex Drug Authority and Central Licensing Authority). Previously, e-pharmacies were mandated to obtain separate license for every state from concerned state authority – this rule could be removed soon.
· License granted by Drug Controller General of India to e-pharmacies would be valid for 3 years and INR 50,000 to be paid by e-pharmacies for renewal of license. A periodic inspection of the e-pharmacy operational premises will be conducted every 2 years to ensure no violation of rules by the e-pharmacies.
· Even though the license requirements will be relaxed, the functionality of e-pharmacies will be closely monitored and for violation of rules e-pharmacies could face stringent penalties.
· Upon violation of rules, the license may be suspended or cancelled provided a reasonable opportunity of being heard is given to the default e-pharmacies.
· Draft rules have scrapped a proposal to create a central server with the intent to route all online prescriptions to individual e-pharmacy portals as a measure to curb potential abuse of prescription medicines by patients.
· E-pharmacies will be mandated to conduct the sale of the medicines via premises with valid retail licenses and to retain records of e-prescriptions of patients.
· Information related to types and quantities of medicines, supply channels/vendor lists will have to be updated by e- pharmacies on their portals on constant basis.
· Onus will be on e-pharmacies to safeguard the data of patients from misuse and they shall not divulge the patient data to any third party except to the central licensing authority for public health purposes only.
· E-pharmacies will be required to establish customer support operating for at least 12 hours every day.
· Online pharmacies will be governed by and obligated to abide by regulations (the Drugs and Cosmetics Rules, 1945, the Information Technology Act, 2000 and the Narcotic Drugs and Psychotropic Substances Act, 1985).
· No advertisement of any drugs over the radio or television by e-pharmacies would be made.
Following the implementation of the draft rules, it is hoped that the e-pharmacies will be able to conduct online medicine business in a hassle free manner by serving the patients in the best possible way, safeguarding patient data and selling genuine medicines to patients. Otherwise, e-pharmacies will be exposed to stern penalties for failure to comply with rules. This will enable patients to access authenticated e-pharmacies to procure genuine medicines.
Bhumesh Verma, is a Corporate Lawyer with over 2 decades of experience in advising domestic and international clients, with a place in “The A-List – India’s Top 100 Lawyers” by India Business Law Journal. He keeps writing frequently on FDI, M&A and other corporate matters. With Research and Inputs by Paruchuri Baswanth Mohan