The government needs to notify the final e-pharmacy rules at the earliest

Dr Varun Gupta, Convenor, Digital Health Platforms (DHP), and VP at 1mg, informs that digital health is a sector with high level of investment activity and Indian start-ups have a chance to lead the world with little clarity from the regulatory bodies, in an interview with Usha Sharma

Give us a brief insight into Digital Health Platforms and its ongoing activities

Digital Health Platforms (DHP) is a not-for-profit, professional organisation with the primary objective to make the best use of technology for improving access to affordable and quality healthcare to the farthest corner of the country. It is an industry association of companies that have forayed into many new and aligned businesses in the digital health space including e-pharmacy, telemedicine, diagnostics, health information and much more. DHP members comprise well-qualified professionals with a strong pedigree and globally acclaimed track record, aimed to streamline the healthcare sector of the country using technology. We have been persistently working on various critical sections of digital health including e-pharmacy. We are also actively involved in promoting self-governance norms, defining and encouraging best practices for the industry, engaging with the policymakers and civil society for issues pertinent to digital health, research and capacity building. DHP is also actively involved in building capacity to promote the sector’s agenda of bringing accessibility to quality, affordable and authentic healthcare for the citizens.

The recent pandemic has clearly shown that both physical and e-pharmacy infrastructure need to co-exist and are important to improve access to quality and affordable medicines

As an organisation, what efforts are you taking to make the e-pharmacy sector acknowledged by the government and safeguard its functioning?

We believe that powered by technology, digital healthcare can immensely help improve access, authenticity, affordability and accountability in the Indian healthcare landscape. We are much inspired and encouraged by the key work that the government is doing in the areas such as National Digital Health Mission, Ayushman Bharat, Digital India, Start-up India, and enhancing the ease of doing business.

We have been building the e-pharmacy sector block by block, and today, it has braved the challenges posed by the COVID-19 pandemic. It gives us great pride and hope in saying that the e-pharmacies proved to be the backbone in the battle against this pandemic, and we have continuously focused on making life-saving drugs available in every nook and corner of our country. For e-pharmacies in India, it has been non-stop operations on-ground since the COVID-19. They have been at the forefront providing lifesaving medicines and all healthcare needs at doorsteps. The recent pandemic has clearly shown that both physical and e-pharmacy infrastructure need to co-exist and are important to improve access to quality and affordable medicines. Realising the importance, the Union Home Ministry, vide order number 403/2020-D, dated March 24, 2020, has specifically mentioned pharma as essential goods, and delivery of medicines (pharma goods) through e-commerce as an essential service. It is evident that the technological advancements that e-pharmacies bring to the retail pharmacy sector are clearly the way forward for the development and progress of the sector.

The process of bringing out e-pharmacy rules was initiated by DCGI in 2015 – an extended process of multi stakeholder consultation was conducted over the last five years, with the active engagement of all stakeholders. This issue was discussed multiple times at different meetings of DTAB and DCC since 2015. DTAB (Drugs Technical Advisory Board) has approved the draft rules on June 11, 2019. We have prepared and submitted representations to the Government after detailed consultations with several stakeholders. We welcome the move made by the Government of India to bring e-pharmacy Rules with an aim to harmonise existing laws/guidelines like IT Act, D&C Act and Rules and PN-2, 2018. This is similar to other sectors like FSSAI Guidelines for E-Commerce Food Operators (FBO Guidelines). However, it is important to note that e-pharmacy is well covered under existing laws. There is no violation of any existing act and rules in the current e-pharmacy model, however, progressive regulatory clarity will help in ease of business and sends a very positive signal to all stakeholders, including patients, local regulators, and prospective investors. The implementation of a robust Pharmacy model needs to be based on the following principles:

1. Patient safety

2. Proper access to medicines

3. Authenticity

4. Level playing field with the same rules without selective bias

DHP operates on the objective of providing last-mile access of quality healthcare to one and all.

How is the delay in notification of e-pharmacy rules affecting the sector?

The retail pharmacy sector needs a lot of supply chain, technology and access solutions to make healthcare delivery more efficient and affordable. A prerequisite for this is a simple and clear regulatory pathway for innovation to thrive in this important space. Moreover, e-pharmacies in the country align very well with the national development objectives and have clear and tangible benefits to consumers as well as the industry. Moreover, a vibrant e-pharmacy sector continues to be a key element in successfully implementing the National Digital Health Mission and achieving Universal Health Coverage. By leveraging technology in a smart way and under appropriate regulatory control, the e-pharmacy sector has a scope of adding immense value to the existing pharmacy retail industry in particular, and the overall healthcare sector at large.

The Government needs to notify the final e-pharmacy rules at the earliest, to unleash the role of technology for improving access and affordability of quality medicines.

However, the delay in the notification of Draft Rules causes unnecessary chaos and anxiety among all the stakeholders, including potential investors. Our partners are unfortunately often discriminated against, harassed and subjected to disproportionate scrutiny due to the absence of e-pharmacy Guidelines. Progressive regulatory clarity will help in ease of business and sends a very positive signal to all stakeholders, including patients, local regulators, and prospective investors.

Other sectors such as transportation, food, retail, logistics have seen very strong investor interest and multiple billion-dollar companies emerge; however, a large sector like health which really needs investment has lagged behind and many startups have given up due to the regulatory overhang and lethargy in this sector. Globally, digital health is a sector with an extremely high level of investment activity, and Indian startups have a chance to lead the world, with some little clarity from the regulatory bodies. Vested interest groups in this sector, coupled with genuine understanding issues around the business model have hampered this sector – it needs a fresh visionary approach, which we hope is now evidently clear in India and around the world.

What is driving the e-pharmacy business in India and how organised is it in the present scenario?

The growth of e-pharmacies in India is being driven by the transformational changes and benefits they are bringing to the table. The conventional pharma supply chains are not optimised and have several gaps, which cause wastage, delays and risks of not of standard quality medicines entering the markets. The unstructured nature of the pharma retail sector leads to greater costs for consumers. These are areas that e-pharmacies have focused on and in the last five years, they have been steadily working to make the supply chain more transparent, efficient and bring traceability to ensure convenient access to essential medicines for the consumers.

The e-pharmacy model helps with better purchasing margins, better inventory management, increased reach, reduced prices and greater provision of value-added services to the consumers. Innovation and technology are at the core of e-pharmacy operations, which results in benefits for the consumers and the entire retail pharmacy value chain in terms of access, quality, choice and awareness, data records, transparency, and data analytics. The sector is highly organised and currently, over 50 companies are active in the domain.

It is assumed that the reach of online pharmacies as against offline pharmacies is limited. How do you plan to expand it?

This is purely a myth due to two reasons:

E-pharmacies have built an offline/online integrated model which leverages an extensive network of licensed physical pharmacies with registered pharmacists. This network gives e-pharmacies a highly efficient last-mile delivery supply chain which successfully enabled them to deliver medicines and healthcare services to patients across 22000 pin codes in India.

Another highly impactful benefit of e-pharmacies is the much higher fill rate (95 per cent plus, Source: RedSeer IP) of medicine orders received by them. Each e-pharmacy platform has access to numerous licensed pharmacies. They are thus able to locate the medicines and deliver them to the patients with greater success. The e-Pharmacies follow a strict no-substitution mechanism and deliver only the medicines mentioned prescribed and no other alternatives.

Could you dispel some myths around e-pharmacies and elaborate on the impact that e-pharmacies can create for the society/patient?

Consumer safety is paramount to us – we are very conservative, organised and disciplined in our approach when it comes to consumer safety. In the e-pharmacy model, transaction and prescription record is available for all the medicines including OTC medicines. In addition, medicines can also be traced back to the channel/ manufacturer/ supplier thereby making the market a lot more transparent. Hence, ensuring authenticity is strictly maintained in an e-pharmacy model. This is contrary to the myth that the e-pharmacies creates an entry for sub-standard medicines.

The laws against poor quality are stringent, but a non-digitised/ cash dominated grey channel ensures poor compliance and accountability. Whereas, e-pharmacies ensure a fully auditable and accountable supply chain with a full Track and Trace right up to the consumer.

Moreover, there are stringent requirements for vendor on-boarding. Only vendors compliant under the Drugs and Cosmetics Act and possessing other required licences (such as FSSAI) are on-boarded by the ePharmacies. The players dealing with poor quality medicines, out of their own self-interest, stay away from traceable systems and operate in the ecosystem that has non-recorded and cash-based transactions.

How can e-pharmacies become a high-value partner with for the government and its different schemes?

e-pharmacy technology has the ability to transform government initiatives in several ways to successfully implement its schemes and initiatives.

Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP): The cost of medicines is still borne out-of-pocket by citizens. The government launched the Janaushadhi Pariyojna to provide quality generic medicines through more than 6300 Jan Aushadhi centres are functioning across 726 districts in the country. The Sugam Mobile app was launched to drive awareness about nearby Jan Aushadhi centres. However, the consumers have to physically visit the Jan Aushadhi centres to purchase the medicines. The travelling cost and other indirect cost diminish the intended price benefit. e-pharmacy technologies for home delivery of medicines can amplify the efforts to ensure access to affordable and quality medicines. Buying medicines from Jan Aushadhi stores from the comfort of the consumer’s home is especially highly valuable for senior citizens and those suffering from physical debilitation and incapacitation. It is also beneficial for those residing in remote areas with inadequate access to these stores.

National Digital Health Mission: A vibrant e-pharmacy sector continues to be a key element in successfully implementing the National Digital Health Mission, e-pharmacy operations are completely digital and all details pertaining to every transaction are documented can provide invaluable data and information necessary for the successful implementation of the NDHM.