Mumbai : The Department of Pharmaceuticals (DoP) has called on the pharmaceutical industry to adopt innovation as a driving feature of its business strategy which will help the industry sustain growth and expansion.

“Industry would have to focus on drug delivery and drug development, as well as innovating greater automation, green manufacturing which will also become more critical in production efficiency. The use of AI, NLP, analytics in clinical functions, research cycles will also see greater convergence in the IT and healthcare sector. The sustained growth and expansion of Indian pharmaceuticals in the global market will now rest predominantly in its ability to capture the value of innovation,” said DoP secretary S Aparna while addressing the Global Innovation Summit 2021 held by Indian Pharmaceutical Alliance recently.

Talking about the policy intervention in facilitating innovation, she said, “Pharmaceutical sector is a highly regulated sector. Research in new products is regulated across the entire cycle from conceptualization, design, clinical studies to pharmacovigilance. The cost, time and effort needed in developing new molecules and biologics are enormous. The public health benefits of developing higher and availability of more affordable and efficacious medicines are very significant. The innovation in the pharma sector is almost like public good. Public research in the pharma sector is dispersed across the large research institutes working under various departments like CSIR, Department of Biotechnology, DoP. Convergence and collaboration also need policy support.”

DoP has recently released a draft discussion paper on policy catalysed R&D and innovation in the pharma and medtech sector. “This policy tried to address the above aspects which are essential to achieving large scale R&D spending and innovation driven goal in pharmaceuticals. The policy aims to create an ecosystem approach for innovation in the sector, so that India can aspire to become a leader in drug discovery and also innovative medical devices to incubate an entrepreneurial environment,” stated DoP secretary.

The policy focuses on strengthening the regulatory environment, incentivising investment in the pharma sector for innovation and creating a facilitatory and collaborative ecosystem for innovation. Process optimization is one of the key aspects of making policy functional wherein regulatory body and industry work together to reduce the process overlapping, establish timeline in requisite approvals, reduce compliance burden, she pointed out.

The second aspect of the policy would be to have a technology based single end to end regional portal which can be used by different regulators and a single interface between innovators and regulatory body, she added.

These policy prescriptions are aimed to bring transparency, timeliness, predictability in processes and outcomes around regulations and support to facilitate innovation. Health ministry has already initiated steps to streamline the regulatory system along these objectives, she stated.

Policy also focusses on improving existing institutional capacity to enable regulators to deal with innovative products—biopharmaceuticals, medtech products. The policy also suggested that NPPA should be supportive in pricing of innovative products while pursuing affordability as an overall objective, S Aparna added.

She also stressed the need for review of multiple regulatory legislations in pharmaceuticals to remove inconsistencies and redundancies.

She further said the policy also focuses on incentivising public and private investment in research. Policy also suggested measures to provide incentives by introducing a tax regime, funding support in R&D spending, specific support to SMEs, creating seed capital funds etc.

Policy also stressed the need to put in place an enabling ecosystem which will design and support innovation and cross sectoral research as a strong institutional foundation of sustainable innovation in the pharma sector.

“Building institutional ecosystem will also help create the balance of equity with efficiency and allow both the market and the societal forces towards the goal of universal healthcare,” she stated.