Advancement of e-commerce in India significantly opened an arena to market most of the products which can reach almost everybody. Online pharmacy is one among the products which is about to create a huge demand in upcoming days. An online pharmacy is an internet-based vendor of prescription drugs, and the term encompasses both legitimate and illegitimate pharmacies. The sale of medicines outside the regular retail pharmacy is not new. It has just flourished in this internet age. In late 1980s, pharmacies began selling prescription medications via mail order in the US. Later this mail order business transformed into first internet-based pharmacy, soma.com, in January 1999. Shortly after that the internet pharmacy was launched in UK. Estimates showed that there were more than 1000 websites selling medicines as of early 2004. Retail pharmacy has so far remained the biggest source of medicines for the Indian population. Remote areas in the country too are benefited with retail pharmacies only. Perhaps, since they are not aware of the concept called online pharmacy or lack of basic requirements like internet, a huge section of the Indian population is not buying medicines online. However, now things are changing. With the introduction of devices like smart phones, coupled with govt and private sector initiatives, internet is reaching almost every nook and corners of the country. Technology can help in meeting the healthcare objective of India. Indian govt is planning to spend Rs. 500 crore on computer literacy project for 50 lakh people over a period of 3 years. This would help Indian citizens to access govt services in the fields of e-education, e-health and e-governance. Healthcare providers in India are also expected to spend $1.1 billion on IT products and services in 2014. With the govt focusing all its energy for affordable healthcare to all using IT and telemedicine which also do not have a mandate in the laws, it is only a matter of time when all these pharmacies are brought under the ambit of a revised law. India is strengthening the nutraceuticals and Ayurveda for wide scale use. India would be required to formulate suitable laws for ayurvedic and nutraceuticals to facilitate these changes. Indian govt is also planning to establish an e-health authority to maintain electronic health record in India.
At present, the D&C Act does not allow sale of Schedule H medicines without a doctor's prescription. In fact, even OTC pharma products can be sold only by licensed retailers. The D&C Act 1940, and the D&C Rules 1945, have guidelines on the sale of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including for labelling and bar coding. There are multiple laws in India that govern dealing with food, health, cosmetics, drugs, medicines and nutraceuticals in India. Online sale and purchase of prescribed drugs and medicines in India is collectively governed by these and other laws. Many online pharmacies in India are inviting legal risks by not following the applicable laws in this regard. These laws are also too old to deal with the advancements in technology and is currently a grey area.
There are some other issues too associated with online availability of medicines. This encourages more self-medication. The medicines do require appropriate storage (temperature) for retaining potency. There is no assurance of temperature control either at their storage points or during transport. The patients loose the opportunity to have face to face discussion with the professional pharmacists. The internet has removed the boundary among the countries. The brand names may often cause confusion. There may be same brand but with different drugs (even the look alike drugs). Ultimately the patient is at receiving end getting wrong medicines. In absence of clear cut regulation, the Indian public are likely to fall prey into the trap of internet pharmacies losing both money and their health.
The DCGI has called for formulating a framework for online sales of medicines through e-commerce channels. "The role, responsibilities and liabilities of e-commerce marketplace and the product sellers need to be clearly defined”. It becomes even more critical to have a framework in place when the intermediary is selling drugs where the safety and health of the consumer is of paramount importance," industry body Ficci's statement quoting DCGI GN Singh said. The industry body said it has been appointed as the nodal agency by the DCGI for consolidating the guidelines and was to get views of OPPI, AICDA, States Chemists and Druggists Associations, IMA, among others, in this regard.
The issue assumes significance in the backdrop of concerns raised over selling of medicines on online portals. In April, Maharashtra FDA had raided the premises of Snapdeal.Com for allegedly selling medicines, including prescription drugs. The Maharashtra FDA has also raided 27 online pharmacies located in Mumbai, Thane and Pune and seized drugs worth Rs. 2 crore.
As such, selling medicines online is prevalent in developed markets and its mushrooming in India is a consequence of the booming e-commerce segment in India. But, clearly selling OTC medicines online, which is permissible, is quite different from selling prescription drugs online where the attendant dangers of abuse are high.
“A prescription issued by a doctor cannot be re-used randomly. There is a danger that scheduled drugs can be re-ordered and misused by the consumer,’’ JayeshLele, president, IMA, said. “Besides, there are several 'do’s and don’ts' with regard to storage and dispensing of prescription medications that need to be adhered to,’’ he added.
According to Lele, self-medication is a rampant practice in India, and online sale of drugs would only encourage it. “Indiscriminate use leads to patient resistance which is very dangerous as has been the case with tuberculosis drugs.’’
KK Aggarwal, secretary general of IMA, highlighted another challenge. He said that data generated from online business could be misused. Websites may use data to sell luxury items to people who visit online stores for costly medicines. They may even sell the data to hospitals and doctors, he warned.
While the Supreme Court has ruled that doctors cannot give consultancy on phone, except during emergencies, the attempts to use technology to render medical services has also not taken off.
“Acquiring medicines online may initially offer some cost benefits and will minimise the stress and the time which usually happens in Western countries. In Western countries laws are very strict and a lot of time is spent in queues where patients have to wait for pharmacists to fill their prescriptions,” says DilipKadam, executive member, AIOCD.
The EU in its Falsified Medicines Directive has mandated a common logo for legally operating online pharmacies/retailers in the EU Member States as per its guideline 2011/62/EU. Subsequently it implemented Regulation 699/2014 which mandated use of common logo to identify the legally operating pharmacy retailers. The global regulatory authority viewed the usage of a common logo one of its measures to fight against fake medications. The implementation of a common logo would ensure technical, electronic and cryptographic requirements for verification of its authenticity of the online pharmacy provider.
“We are strongly opposed to the online medicine sale as is prevalent today,’’ JS Shinde, president, AIOCD, which represents 7.5 lakh retail pharmacies, said.
As far as India is concerned, we have no dedicated e-health and telemedicine laws 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. 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.
When technology is used for medical purposes, it gives rise to medico legal and techno legal issues. In US, the Health Insurance Portability and Accountability Act of 1996, Health Information Technology for Economic and Clinical Health Act, etc are some of the laws that take care of medico legal and techno legal issues of e-health and telemedicine.
Individuals and companies selling pharmaceutical products through website are also required to comply with various laws. These include laws related to medicines and pharmacy profession and cyber law of India. Surprisingly 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 they are violating the provisions of IT Act, 2000.
Though internet pharmacies are illegal supplying medicines, the e-commerce of medicines cannot be stopped in this internet age and buying medicines online has become a convenience for the patients, the reliability and the authenticity of such online chemists have regularly been questioned by the experts. There is need for legalizing and regulating them is best option.
(Dr. B Ramesh is principal, Chava Narasimha Rao is VI year Pharm D student, Vedamurthy Joshi, is asst professor of Sri Adichunchanagiri College of Pharmacy, BG Nagara, Nagamangala Tq, Mandya dist, Karnataka 571 448)