What does NDA’s expertise within the life sciences encompass, and what types of clients does the firm typically take on?

MA: NDA is a global research-driven law firm with offices in Mumbai, Bangalore and Delhi, as well as in Palo Alto, New York, Munich and Singapore, where we have the license to practice Indian law. Today, we work primarily with global companies, particularly those headquartered in the US and EU who are interested in expanding their operational presence to India. With these MNCs, we take on cases dealing with disputes as well as corporate, IP, and regulatory work, and we currently have 17 of the top 20 pharma companies as our clients.

DP: NDA also specializes in crisis management. Because we represent MNCs, we also deal with issues that can trickle down from other countries that Indian regulators monitor and verify in terms of impact on the Indian population.

How did the pandemic impact the regulatory framework for medical devices?

DP: Covid-19 brought to the government's attention how many substandard products were in circulation, such as ineffective PPE kits. As a result, the Indian government began expanding the regulatory framework, bringing products that had long been in the market into the regulatory fold for the first time. Foreign players have the relative advantage that they had already been concerned with meeting different regulatory requirements abroad, so they are now seeing a more level playing ground within India as domestic players have to step up to meet these standards. As these standards balance out, prices may also go up accordingly given the compliance costs. To limit this to some extent, India has price control measures. Given all of this, the medical device industry is currently in flux. By the end of 2023, the full extent of the revised framework should be in place for medical devices.

In what ways has the digital landscape transformed in recent years?

DP: NDA has been pushing for digital health and telemedicine to be regulated and legitimized for years, primarily because we saw these resources as a way to help overcome the issue our country faces in having a concentration of healthcare practitioners in urban areas yet very little healthcare practitioner access in rural areas. Despite its potential, for years digital health was complicated by cumbersome regulations. If a doctor was sitting in Mumbai, whether that doctor was allowed to consult with a patient in Bangalore was something the medical council in India had previously taken a very conservative view towards. Pre-covid, they would not be permitted unless the doctor was registered in the same state as the patient, making telemedicine as a practice very difficult to implement. The workaround had been to have physician-to-physician consultations in which the final advice was given by a doctor located within that jurisdiction. Thus, Covid's impact on the industry was transformative as the government finally put a legitimate stamp of approval on the entire practice. At a central level, the regulations allow doctors to now consult with any person in the country. This was immensely beneficial for rural populations, as you can leverage the use of primary care workers at rural areas who were not necessarily qualified from a medical background with support from practitioners in urban areas.

MA: Many doctors who had retired or were not very active in their practice became very busy again, as all they needed was a laptop and strong WIFI. We are at the tip of the iceberg in terms of what telehealth will come to offer India.

What excites you most about the future of India’s life sciences sector?

MA: The most exciting fields will involve innovative technologies in healthcare, such as AI or robotics. It will not be long before tech dominates the sector. As a result, I foresee significant consolidation of hospitals to manage the costs of setting up infrastructure for these new technologies.