India's unpredictable policies affect investment in pharma sector: OPPI

India’s unpredictable business environment and lack of infrastructure are the barriers that pharma industry is facing today. The government must lead the way in bringing together world-class infrastructure (research centers) in India to bring newer medicines, treatments and address the unmet medical needs of the millions of patients, said Kanchana TK, Director General, Organisation of Pharmaceutical Producers of India (OPPI) in an exclusive interview with Yahoo India. OPPI represents research-based pharmaceutical companies in India and engages with the government and other stakeholders to find sustainable healthcare solutions. Following are excerpts of the interview with Kanchana:

1. What are the structural problems being faced by the Indian pharma industry?

Some of the challenges that the industry faces can be categorized into three broad areas:

Regulatory- We keep the patient at the center of all that we do. Quality of medicines and patient safety are the tenets on which our members do business. Currently, there are many rightful concerns about the ‘quality’ of drugs. Therefore, it is critical to have the appropriate infrastructure in place that keeps a check on the quality of drugs and their formulations, their bioequivalence, and compliance with international standards of safety.

IPR- While the National IPR Policy signals respect for all forms of intellectual property with the intent to foster a culture of innovation, the real challenge, however, lies in the implementation of this Policy and in its adherence to the spirit of innovation. In India, there is no notification of the grant of the patent by the patent office and the grant of marketing approvals. While one arm of the government grants protection to an innovator in a form of a patent, the other arm grants marketing approval to a third party. Furthermore, an infringer is not even required to obtain the said marketing approval if the product sought to be launched is not a new drug (more than 4 years in the market) under the Drugs & Cosmetics Rules: in this case, a manufacturing license from a State FDA suffices. Another concern is the lack of effective and meaningful protection for commercially valuable test data in India. There is a lot of time, cost and complexity involved in the drug development process and therefore, Regulatory Data Protection (RDP) is important for the research-based pharmaceutical industry. While most countries which have RDP provide protection against reliance on the regulatory data in submissions by third parties, India interprets RDP differently and limits protection against disclosure only.

Pricing-Price Control cannot be used to expand access to medicines. The need of the hour is in creating a health infrastructure that is hospitals, medical staff, primary health centers and network hospitals with dispensaries that are stocked with medicines.

2. What are the reasons for a slowdown in the pharma or healthcare industry? Is it the demonetisation effect?

Yes, there has been a slowdown in the pharma industry. According to a November 2017 IQVIA perspective of the Indian pharma market, during the period of demonetisation, 78% of the stockists recorded a drop in the sales (on a month on month basis), while 68% of chemists reported a drop in sales (on a month on month basis).

 3. Has the implementation of GST impacted the Indian pharmaceutical industry?

According to a November 2017 IQVIA perspective of the Indian pharma market, the months of April-June 2017 have shown a dip in the pharma sales. Almost 90% of the stockists, according to the IQVIA survey, experienced a decline in sales during this period.

4. Has the pharma sector experienced any change after the new government has come to power?

Healthcare has become part of the political agenda. Critical announcements in healthcare and increased emphasis on building citizen engagement shows the government’s commitment towards improving access to healthcare. The National IPR Policy released in 2016 aims to foster innovation and protect intellectual property and encourage research, while the National Health Policy released in 2017 aims at addressing ‘the current and emerging challenges necessitated by the changing socio-economic, technological and epidemiological landscape’. As a country, we need forward-looking policies to address the unique healthcare challenges we face

 5. What steps would you like the government to take to boost the pharma sector?

One significant step would be in the direction of building a strong government-academia-Industry partnership that focuses on bringing newer medicines through dedicated research. Currently, the problem is not the lack of intellectual talent, but a lack of infrastructure. There are few national labs and national R&D centers. According to an article in (May 2016), over the last ten years, 332 out of the 579 medical teaching institutions in the country have not produced a single research paper. Innovation and Research is the bedrock on which the industry rests on and it is only through research that we can bring newer medicines and treatments to address the unmet medical needs of the millions of patients across the globe. The government must lead the way in bringing together world-class research centers in India partnering with academia and industry.

6. What are the barriers that research-based pharmaceuticals industry is facing in India? How can these barriers be removed?

The unpredictability of the Indian business environment is one of the barriers that the industry is facing today. The ‘unease’ of doing business, with the lack of predictable policies affects further long-term investments. We believe that collaboration is the way forward. Involving stakeholders and increasing engagement and consultation with each of them will help in building a healthy ecosystem.

7. How can healthcare facilities be improved in India? How affordable and quality healthcare can be provided to each Indian?

With India’s enormous population, one of our biggest challenges continues to be that of providing quality healthcare to all. A good place to start will be to enhance public expenditure on health from the current 1.4 percent of GDP (gross domestic product) to 3 percent by 2020. Currently, there exist big gaps in the healthcare infrastructure of the country. According to the World Banka data, India houses 18% of the world’s population but just 6% of the global number of hospital beds. Access to healthcare is further limited in rural areas. According to a WPRO-WHO report, 3 out of 5 hospitals, 3 out of 4 dispensaries are in urban areas. This clearly indicates the need for the government to focus on building capability and strengthening the healthcare infrastructure of the country.

8. What approach can pharmaceutical companies take to expand healthcare in India, provide more accessible medicines, within a robust IP environment?

The long-term solution to India’s healthcare challenges requires a holistic approach and a critical evaluation of our existing systems. We need sustainable policy solutions to address healthcare financing, infrastructure, and human resource challenges. These elements come ahead of the price of treatment or medicines. The real barrier to access is the inability to pay out-of-pocket and the lack of insurance coverage. What India lacks is a viable public healthcare model which requires a combination of financing and non-financing measures. Besides more public expenditure on healthcare, we need focus on infrastructure and capacity building as well as more doctors and nurses. Over 60% of the patients in rural India have to travel over 5 km to reach a healthcare center for inpatient care. The ratio of doctors to population is half of that of China and one-third that of the United States.

9. Do you think there is discrimination against women in the workplace? If yes, then how one can deal with it?

I wouldn’t use the word discrimination. We have moved away from that. What would be ideal is a gender-neutral system based on merit and talent. That would mean discarding stereotypes about women at work. Equal opportunity will lead to balanced leadership and truly empower any gender and allow them to cohabit and co-create.

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