Technology entrepreneurs and business houses are betting high on e-health, m-health, online pharmacies and telemedicine related business ventures. India government is also trying to streamline the regulatory environment in this regard but it has still to do lots of work in this regard. For instance, the Electronic Health Record (EHR) Standards of India have been prescribed and establishment of a National E-Health Authority (NeHA) of India has also been proposed. However, no dedicated laws for e-health/m-health, telemedicine, online pharmacies, etc have been formulated by Indian government so far.
Information and communication technology (ICT) is proving a useful tool in all spheres of our day to day lives. This also applies to the healthcare sector of India. Medical practitioners and hospitals have started using ICT to effectively manage their medical services. However, there is a problem with this growing use of ICT by medical practitioners and hospitals. In their zest to use ICT for furthering their medical objectives, these medical practitioners and hospitals are flouting Indian laws. Simply putting we have no dedicated telemedicine laws in India and online pharmacies laws in India. However, different laws of India govern the telemedicine and online pharmacies aspects in India.
As on date the online pharmacies in India are violating Indian laws and Indian government is well aware of these violations. In fact, online pharmacies websites of India are under regulatory scanner and punishment may follow. Despite contrary beliefs, online sales of prescribed medicines in India cannot be done through a mere opening of website. The growing craze of e-commerce among Indian medical entrepreneurs has witnessed a spurt of many online pharmacies and telemedicine operations in India. However, most of them are violating the laws of India and some of these laws prescribe very serious punishment for these violations.
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. Time has come to enact a dedicated law that allows online sales and purchase of prescribed drugs and medicines in India.
There is a tendency among medical e-commerce players in India to ignore Indian laws. The Walmart probe , banned drugs regulation in India , e-trading of medicines, digital communication channels , etc have proved that Indian laws must not be taken lightly. Similarly, many telemedicine and online pharmacies initiatives in India rely upon cloud computing without knowing and following the legal and regulatory issues of cloud computing in India. Those engaged in telemedicine and online pharmacies must keep in mind the legal requirements prescribed by Indian laws like Information Technology Act 2000, Drugs and Cosmetics Act, Indian Medical council Act, Code of Ethics Regulations 2002, etc.
The biggest mistake that most of the telemedicine and online pharmacies initiatives in India commit is by believing that offline medico legal requirements can be safely used for online requirements. This is not true and is a fatal misconception as it may bring legal consequences and liabilities.
Online dealings of medicines and healthcare services have their own set of problems and legalities and they must be fully complied with to do an online business. Selling medicines online and providing of online healthcare services in India is not like selling other day to day commodities and they have grave risks attached with their very dealings. Great precautions and absolute compliance with the laws of India is required for their online operations.
The ultimate call is for Indian government to take as it has failed to regulate this much needed field so far. Not only Indian government failed to make dedicated laws in this regard but it has also failed to take stringent action against those who are running illegal online pharmacies and telemedicine shops in India.