Mumbai, Maharashtra, India
In a press conference in Mumbai today, the Indian Internet Pharmacy Association (IPA) called for the regulators and the government to help ensure there is an end to the harassment faced by the new entrepreneurs in this space. The IPA has explained its business model in detail and is demanding a level field for all players in the pharmacy space, without favour or bias. They seek clarity on guidelines to enable legitimate players to develop their business in this space and bring in the much needed innovation and technology driven transparency in this sector, leveraging best practices from across the world.
The ePharmacy business model has been in the news lately for multiple reasons. At one end, consumers are benefitting from the increased transparency, access, affordability and convenience; also the model holds tremendous promise for the regulatory body to tackle the issues of fake medicines since the entire supply chain is well documented and tracked, and also ensures better pharmacovigilance. The new-age retail pharmacies want to partner with digital platforms to develop and grow their business; and investors have shown a keen interest to participate – however the unprecedented and high handed activity by AIOCD and Maharashtra FDA have brought up serious questions around the re-strengthening of the “license raj”, reduced ease of doing business and a negative environment for innovation, especially in Maharashtra.
As per the IPA, taking inspiration from the vision for Digital India – eHealth has to be an integral component of this all-encompassing vision and the country has an opportunity to transform access to quality healthcare for citizens across the nation. A core component of the eHealth plan is e-Access to medicine, through mobile and internet based platforms. Lack of access to continuing treatment is not only associated with poor health outcomes and/or premature death, but also impacts the economic growth of the country. Also, the absence of full traceability of medicines across the supply chain has led to significant issues around medicine authenticity, safety and quality. This problem can only be addressed through an evolved system leveraging technology to track medicines right up to the consumer.
Thus accessibility, affordability and lack of awareness are the major challenges for consumers to access good quality medicines. Technology, especially the Internet, adds immense value by improving accessibility of healthcare services to the most remote regions of the country. With the help of technology, healthcare is likely to undergo a revolution and will upgrade to a stage where the consumer would be informed and empowered. Also, better tracking would ensure easier recalls, enhanced pharmacovigilance and ensure better patient compliance
In today’s world, when most products and services are conveniently delivered to the patients’ door-step, it is imperative we encourage access models that help sick patients avail convenience of medicine delivery without needing to leave their home. In healthcare, perhaps more than any other area, the consumer is unwell and should have easy access to medicines at home, which is now very much possible.
The Internet Pharmacy Association brings together the legitimate players in this segment to improve the last mile access of medicines using digital technologies without compromising the safety of the patient. It aims to contain the potential for any abuse. The IPA which is an association of E-Pharmacy players and their vendors announced that they are specifically being targeted with an apparent bias and operations are put under disproportionate scrutiny by the concerned authorities and governing bodies. The challenge that these companies face today is of stiff resistance, including unwarranted disruptions from the government machinery, particularly in a Maharashtra and Karnataka, and the prevailing trade association that is averse to any new models or transparency in this space.
The IPA members have requested to impress upon the Sub-Committee created by the 48th Drug Consultative Committee to formulate guidelines on the use of Technology & E-Pharmacies to note this model and appreciate its legal validity. They have also suggested best practices from around the world to help draw out a model system of pharmacy retail in India, and are keen to work with the regulator to draw out the blueprint to address all the key issues that plague this sector, which is today one of the most poorly performing and consumer-unfriendly system. All the issues that plague the current system point to a failure of the current model, which needs rapid innovation and technology.
The Drug Controller General of India (DCGI) had earlier directed all the state/UT drugs controllers to keep a strict watch on online sale of drugs and take action against those engaged in online sale of drugs, if that is found to be in violation of the Drugs and Cosmetics Act and Rules there under. The IPA supports all efforts to clamp down on violations of the act and help clear the misconceptions. As clarified by the IPA, there are potentially multiple online pharmacies operating from different parts of the world that need to be monitored and action should be taken against. In most countries, to fight this menace of cross border internet pharmacies, the legitimate players are given specific operating licenses – that are shared with consumers. IPA recommends a similar model for India, and also a crackdown on all illegitimate players, online and offline.
Maharashtra FDA recently lodged a complaint against PharmEasy, one India’s leading E Pharmacy platforms, however, the police has investigated the matter and come to the conclusion that there is no violation of the FDA rules and regulations, vindicating PharmEasy’s stand about legality of their operations. Similarly, in Karnataka, the licenses of vendor partners of Zigy and Medidart were cancelled, and thereafter revoked post investigations. For Zigy, the ePharmacy marketplace, the license for a vendor partner in Bengaluru was cancelled. Post challenging of the cancellation, and after several hearings with the Appellate Court, cancellation was revoked and operations found to be in good standing. However the process led to a few months of income lost for a small vendor partner and has caused concern amongst other small entrepreneurs who wish to partner with digital platforms to grow their business.
PharmEasy in the press conference announced that it operates within the four corners of the law and no aspect of its service model breaches any of FDA’s rules and regulations. PharmEasy seeks to issue this clarification to protect its brand image and dispel any false notions being spread about the legality of its operations. The sales on the platform are affected by the offline retail pharmacies on PharmEasy’s platform only on submission of a valid prescription by the consumers – a practice which is rarely followed by any of the other retail chemists including those who offer home delivery of medicines without any verification of the prescription.
Similar to the incident with Pharmeasy, there have been reported FIRs against 2 companies – mChemist and Merapharmacy. While Rajiv Gulati is the founder of mChemist, and ex-President of Ranbaxy and one of the leading players in the global anti counterfeit and pharmacovigilance movement, most of the founders of the online pharmacies are post graduates from institutions like IIM-A, Stanford, XLRI etc. but are being harassed and treated unfairly. We have engaged and spoken with the regulators at multiple levels, and have been assured of a quick resolution, however deep rooted interest groups seem to be delaying the process. The company Bookmeds (Hyderabad based) is refocusing efforts towards markets like Malaysia and Indonesia owing to lack of clarity in India. Multiple startups have already shut down operations, given that it is very daunting to deal with the regular issues that hamper ease of business, infact they make it very hard to build a legitimate business. In the meanwhile, there is also tremendous pressure on small pharmacy owners who want to partner with digital platforms and grow their business – they are threatened with excessive and aggressive regulatory action. The moves by the trade association and regulators is anti-competitive, against consumer interest and clearly shows bias.
“We are working for the benefit of masses, needy patients so that they can avail affordable healthcare. The harassment to online players will only discourage genuine players and those who wish to bring some change in society”, said Nishi Gandotra, SaveOnMedicals.
The IPA members share the vision which is in sync with the Digital India and Startup India campaigns of the Government. There has been so far been no support or clarification in this space and the sub-committee formed has been showing a fairly biased view on this looking at the statements of Maharashtra FDA commissioner, who incidentally heads the sub-committee to recommend guidelines for ePharmacy models.
The IPA members further shared their recommendations for facing challenges to scale and provide services to the consumers especially in cities like Mumbai, Pune and Bangalore. They stated that their business operations are fully transparent, with all transactions well documented and recorded while there is a willingness to work with the regulators to improve the system. The press conference called in for innovative models for e-pharmacy and e-health access to be encouraged to bring more transparency in the system.