This is the updated version of our previous article on online sales and purchase of prescribed drugs and medicines in India. Many stakeholders have shown great deal of interest in opening of online pharmacies in India. However, lack of knowledge about the applicable laws and their proper compliance has forced them to postpone their entrepreneurial dreams for the time being.
As on date we have no dedicated telemedicine laws in India and online pharmacies laws in India. But different laws of India govern the telemedicine and online pharmacies aspects in India.
However, till now the telemedicine and online pharmacies laws in India and their legal implications and liabilities are not clear to online pharmacies website owners. Similarly most of the online pharmacies stores and websites in India are not aware about the cyber law due diligence requirements and Internet intermediary liabilities.
As a result illegal and unregulated online sales of prescribed medicines in India have increased significantly. Now online pharmacies websites of India would be brought under regulatory scanner and punishment may follow for those who do not comply with the legal requirements in India.
Online sales and purchase are governed by electronic commerce transactions. We have no dedicated e-commerce laws and regulations in India. However, a basic level legal e-commerce framework has been provided by the Information Technology Act, 2000 (IT Act 2000) that is the cyber law of India.
While we have basic level e-commerce legal framework in India yet e-health related legal framework is missing. For instance, e-health in India is facing legal roadblocks. Till now we do not have any dedicated e-health laws and regulations in India. The legal enablement of e-health in India is urgently required.
When technology is used for medical purposes, it gives rise to medico legal and techno legal issues. In United States, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Health Information Technology for Economic and Clinical Health Act (HITECH Act), etc are some of the laws that take care of medico legal and techno legal issues of e-health and telemedicine.
As far as India is concerned, we have no dedicated e-health and telemedicine laws in India. Even essential attributes of these laws like privacy protection, data protection, data security, cyber security, confidentiality maintenance, etc are not governed by much needed dedicated laws. Ordinary commodities can be comfortably sold through e-commerce websites. However, health related commodities, especially prescribed medicines and drugs, are not easy to manage in an online environment. This is the reason why we have almost nil online sales of prescribed drugs and medicines in India as on date.
We need a dedicated law regarding e-health in general and online sale and purchase of prescription drugs in particular. The laws that deal with sales of prescribed medicines and drugs were enacted many decades ago when information and communication technology (ICT) driven innovative e-commerce methods were not within the contemplation of the legislature. Naturally, these laws are silent about their applicability to online sale and purchase of prescription drugs and their online trading.
Till now many e-health players are not aware whether the present laws allows or disallows the buying and selling of medicines through websites. Though over-the-counter products are no problem, online trade of prescription medicines is a sensitive issue. There are far too many issues involved regarding safety and authenticity of online drug stores.
Most western countries have allowed online sale of medicines. Even China has recently allowed opening of online medical stores for its pharmaceutical industry when about 20 companies were given licenses in this regard and they are doing well. In India, most players are afraid of engaging in online sales of prescribed medicines because of the uncertainty in the legal framework. Time has come to enact a dedicated law that allows online sales and purchase of prescribed drugs and medicines in India.