Exclusive interview: Ecosystem that fosters innovation key, says A Vaidheesh, President of Organisation of Pharmaceutical Producers of India

Indian pharma industry has to maintain uniform baseline quality standards of the World Health Organisation (WHO) along with good manufacturing practices (GMP). The global quality standards needs to be embedded in every stage of the medicine-making process and across the delivery chain from the R&D laboratory to the pharmacy where the patient buys the drugs, says A Vaidheesh, president, Organisation of Pharmaceutical Producers of India (OPPI), and vice-president, South Asia & MD, India, Glaxo SmithKline Pharmaceuticals. In an interaction with BV Mahalakshmi, he says that a simple patent notification system has to be implemented that includes participation from state-level governments in the regulatory frameworks which ensures non-infringment of patents. Excerpts:

What are the immediate key priorities for the pharmaceutical industry in India?

The recent World Bank’s Ease of Doing Business Report which ranks India at the 77th position from the earlier 100th is a testimony to the fact that the government has been enabling businesses to operate in India. However, if we would like to increase India’s competitiveness in the biopharmaceutical segment and strengthen our vision to become a global innovation hub, we need to focus on four distinct areas which include building an innovation-friendly ecosystem that protects and rewards innovation; strengthening the regulatory landscape by implementing accepted global standards and practices; defining the quality roadmap for the country and driving a culture of quality consciousness in manufacturing, distribution and storage of medicines.

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Given the kind of competition in the industry, how to encourage innovation among pharma companies?

We can start by implementing policy changes to protect and reward innovation — implement a simple patent notification system that includes participation from state-level governments in the regulatory frameworks — that ensures that patents are not infringed. This will usher confidence among research-based pharmaceutical companies in India. Strong protection and enforcement of patents provide powerful incentives that drive and sustain substantial investments in valuable treatments and cures. Experience shows that the level of IP protection influences the prioritisation of biopharmaceutical R&D in middle-income countries and that the location of preclinical and clinical research depends on the IP regime in the country.

What are some key initiatives that OPPI has been working on based on current industry trends?

Currently, we are focusing on two key issues — UCPMP and OTC guidelines. As a responsible industry body, OPPI has been advocating the need for the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) to be made mandatory in order to ensure responsible healthcare for patients. All OPPI members adhere to a stringent OPPI Code of Marketing Practices based on the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code. With the IFPMA releasing a revised IFPMA Code of Practice 2019, the OPPI’s Revised Code of Marketing Practices will come into effect from January 1, 2019.

Keeping the patient at the centre of all that you do, what does OPPI expect as support from the new government?
As the future of medicine is evolving into personalised medicines, immuno-oncology and speciality drugs, an ecosystem that fosters innovation is critical for addressing the unmet medical needs. In this backdrop, we look forward to the government to continue investing in Ayushman Bharat and increasing the healthcare budgets to 3.5% of GDP.

What are the regulatory reforms that are needed to bolster clinical research in India?

One approach could be building strong public-private partnerships for innovation. For example, the Chinese approach of linking government, industry and academia in the pursuit of creating a sound base for drug research. This could be explored further as we start to build models to encourage domestic research. Clinical trials are critical to new drug introductions and the decline of clinical trials in India as opposed to China underlines the relative strength of China’s innovation ecosystem. In order to put India back on the clinical trials map, it is a top priority for the government as well to launch a new set of guidelines in the coming months.

How are you working with other stakeholders in building a quality culture?

Patient safety is critical and quality is non-negotiable. Quality should be embedded in every stage of medicine-making and across the delivery chain right from R&D laboratory to the pharmacy. In June 2018, OPPI in collaboration with the department of pharmaceuticals and major industry associations organised the first-of-its-kind Quality Summit 2018 to set an agenda that would define the quality roadmap for India.