Indian Pharma & Life Sciences: 2023 Outlook
EXPERT OPINION ARTICLE BY:
Darren Punnen & Dr. Milind Antania,
Leader – Pharma & Life Sciences Practice (DP) and Lead – Pharma, Healthcare, Medical Device and Digital Health Practice (MA),
Nishith Desai Associates
As India and the rest of the world come out of the pandemic, the question on every change-maker’s mind is this – how can we be better prepared for such a situation? More importantly, how can healthcare systems be reformed to better support the Indian population?
While healthcare reform has been on the cards for years, the unprecedented spotlight it has received in the recent past has provided the right push to get over systemic inertia.
Starting with the principal law governing the quality and safety of drugs, medical devices and cosmetics – the Drugs and Cosmetics Act – a law that has foundationally remained unchanged since 1940 is undergoing its first major update with the introduction of the Drugs, Medical Devices and Cosmetics Bill. As with many other jurisdictions, medical devices are finally being brought out of the umbrella of being regulated as a drug, and is being provided its own standing. This should significantly improve the compliance burden with requirements that are targeted towards devices. Additionally, the bill also seeks to legitimize and regulate an entire industry that has been operating in the grey – online pharmacies. Online pharmacies, while not without its risks, have proven to be beneficial in improving both accessibility and affordability for medicines in India. The associated risks that have been identified such as counterfeit medicines leaking into the distribution channel should be mitigated once the sector is brought within the regulatory fold and quality control requirements are introduced.
India has also been witnessing a significant digital health boom. The disruption seen in the ride hailing industry through aggregation is also being seen in the healthcare space, with platforms being set up for a variety of areas. There has been a rise in telemedicine platforms offering services covering most specialties and even expanding into homecare as well as diagnostic services. These disruptions are positively impacting the accessibility of healthcare services even in smaller towns and cities, which has been a challenge to tackle through offline means for a while.
Affordability of medicines has always been an important aspect of healthcare delivery, especially given that out of pocket payments continue to be one of the primary ways for patients to receive healthcare. However, policy makers have to walk a fine line so as to ensure that efforts in making medicines affordable do not disincentivize the industry from bringing innovative products to the market. There have also been proposals to move away from the existing market based pricing approach and towards a trade margin capping for certain medicines, which again has brought out debates on whether the policy for pricing should first be revised before undertaking these changes. Price control changes are likely to be unraveling over the course of 2023, after which it would be interesting to see how the industry players react to such changes.
In a bid to curb unethical practices between healthcare practitioners and the industry, the government is also in the process of revising the professional ethics code for healthcare practitioners. While the first draft of the revised law appears to have restricted interactions between the two to a bare minimum, it is hoped that with stakeholder feedback, a revised draft will be issued allowing for legitimate and ethical interactions, while filtering out current issues such as high value gifts and hospitality being provided to influence prescription decisions. Additionally, the Government is also coming down hard on the industry from a tax perspective to curb unethical practices. Disallowances in marketing expenditure that went against the existing code of ethics are now being enforced strongly, and is already serving as an effective way to reduce the occurrence of such practices.
The government’s mammoth exercise of providing a universal healthcare insurance cover through the Ayushman Bharath Scheme is also being improved in a timely manner. Over the past few years, the Government has been focused on using the scheme to standardize healthcare delivery, bring down treatment costs and also bring more of the population within the cover. Over the course of 2023, it is expected that there would be strides in digitizing healthcare records through the scheme. One of the primary challenges for the scheme continues to be attracting healthcare players to onboard, especially because of the costs within which they would be required to operate if they participate. To this end, feedback is being provided and actioned, and we expect that changes will be made to the scheme in a manner that makes it more lucrative for more healthcare providers to sign up.
The core principles of improving quality, affordability and accessibility have been at the heart of every healthcare reform. With this holistic push cutting across various parts of the healthcare ecosystem, we expect that by the end of 2023, India will see stability and certainty in regulations, improved access through digital health penetration, and improvements in affordability through the expansion of the ongoing universal healthcare cover. These improvements are already signaling increased interest in domestic and foreign investments, as well as more players looking to enter the Indian healthcare space. With every step taken towards improving the space, it is hoped that the Indian healthcare infrastructure will be strengthened from the ground up, and consequently be better equipped to handle any new threats to public health that may come our way.
- Darren Punnen and Dr. Milind Antani.