We have witnessed significant advancements in treatment of rare diseases: S Sridhar, President, OPPI | The Financial Express

We have witnessed significant advancements in treatment of rare diseases: S Sridhar, President, OPPI

The pharma industry in India has grown from strength to strength since the country’s independence, Sridhar told Financial Express.com.

We have witnessed significant advancements in treatment of rare diseases: S Sridhar, President, OPPI
S Sridhar, President, Organisation of Pharmaceutical Producers of India (OPPI) (FE.com)

The ongoing coronavirus pandemic has affected the pharmaceutical industry but it has also led to the sector’s growth. According to a report by Acumen Research and Consulting, the Pharmaceutical Manufacturing Market is expected to grow at a CAGR of around 15.9 percent from 2022 to 2030 and expected to reach the market value of around USD 1,599.9 Billion by 2030. In India, the pharmaceutical market is expected to report 11-12 per cent year on year growth in the FY 2023 and it is interesting to note that the main driver of this growth is the price rise and further recovery in non-Covid drugs volumes.

Financial Express.com reached out to S Sridhar, President, Organisation of Pharmaceutical Producers of India (OPPI) and he talked about India as an emerging market, the country’s growth as a pharma market, rare diseases and the drugs related to them among other. Excerpts:

There is now a dip in the COVID-19 vaccine boom and many companies have started facing a decline in sales. How companies are looking at this and what will be their way forward?

The pandemic was an unprecedented event during which the efforts of the entire industry were put towards solving this health challenge. Vaccines became a major focus area for companies and governments alike. During the peak of the pandemic, there was certainly an increase in vaccine sales. In India, most of the population is now vaccinated- as of 1 August 2022, India has administered over 2.04 billion doses overall, including first, second, and precautionary (booster) doses. Moreover, we are now witnessing an acceleration in the decline of the coronavirus, which has added to the demand plateau. Having said that, the forecast for the industry remains positive.

We also see enhanced awareness around vaccination – and especially adult vaccination because of the phenomenal rollout of COVID-19 vaccines in the country. The entire ecosystem – from patients to prescribers to supply chain and logistics is now developed to embrace adult immunisation as a concept. This will augur well for wider adoption of other vaccines that are useful to prevent diseases that cause significant morbidity and mortality amongst adults, elderly, and patients with co-morbidities.

According to you, how has the Indian pharmaceutical sector evolved since the country attained independence? What are the key areas that the country needs to focus on?

The pharma industry in India has grown from strength to strength since the country’s independence. From being non-existent in the early years of independence to being hailed as the ‘Pharmacy of the World’, the pharma sector’s progress in India has been nothing but prideworthy. Today, the Indian pharma industry ranks third in pharmaceutical production by volume and the 14th largest in terms of value. This significant growth has become possible because of the future forward policies that have been implemented in the recent past. The government’s push towards ‘Make in India’ has further put the pharma sector in India in a unique leadership position.

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The sector has taken numerous strides and efforts are now being put toward achieving the India@2047 vision. To swiftly attain this goal, it would be important to focus on some critical areas:

Pharma R&D- For the pharma sector to thrive further, there is a need to create an enabling environment for R&D, innovation, and intellectual property. Emphasizing innovation will propel India to become a leader in drug discovery and development, thereby expanding patients’ access to life-saving treatments while also enhancing its prowess to tackle future health emergencies. A draft R&D policy has already been announced by the government and once implemented, it will certainly catalyse the development of a conducive ecosystem for pharma R&D. Similarly, ensuring that innovations and innovative thinking are duly protected, recognised, and incentivised will be important.

Collaboration- During COVID, we witnessed the power of collaborations and the way they accelerated the response to this health challenge. Moving forward, it will be imperative for the industry, to join hands with multiple partners- academia, government, patient organisations, and medical/healthcare start-ups to facilitate knowledge exchange and build a future-ready sector.

Digitisation- Leveraging digital tools will become critical in tackling complex diseases, discovering, and developing next-generation molecules, accelerating clinical trials, and comprehending huge data sets.

Since last year, you have been the President of the Organisation of Pharmaceutical Producers of India (OPPI). What have been your key takeaways till now and according to you, what immediate changes are needed in the Indian pharma sector?

As the President of OPPI, an association representing research-based pharma companies, firstly I would like to applaud the government on its efforts towards meeting the healthcare needs of the people in the country, in such trying times. During the pandemic, with the government at the helm, the pharma industry was able to make significant contributions in areas of preventive healthcare and medication access. The country’s pandemic success story is a testimony to the power of public-private partnerships and quick regulatory decision-making.

The past year has also emphasised the need for an innovation ecosystem, a robust infrastructure for not just drug production but drug research and development, and the need to build skilled manpower including scientists, researchers, and technologists who can be the changemakers of the future.

Access and innovation have always been the two key driving factors for progress in healthcare, not just in India but across the world. The COVID-19 pandemic has further underscored the critical importance of these aspects to secure both the immediate and long-term health and well-being of our citizens.

Moving ahead, as we adopt futuristic approaches to meet our healthcare goals, we will need to capitalize on Aatmanirbhar Bharat to create visibility for the country as a manufacturing and innovation hub. We will also need to benchmark ourselves against global standards of quality while also focusing on creating a more enabling regulatory environment. Aligning and integrating our regulatory system with the global regulatory system such as through full-time membership of the International Council for Harmonisation – will ensure interoperability and faster and smoother adoption of drugs developed in India across the world and vice-versa.

How do you look at India from an emerging market perspective at a time when several global MNCs are selling brands in India?

India as a market is unique in its characteristics and therefore, presents a favourable environment for global pharma companies to operate in. Today, the question is not ‘Is it worth setting up operations in India?’ but ‘How can we provide more and more patients with quality medicines?’.

The country’s growing population coupled with a steady rise in disease prevalence is leading to an increase in the patient pool. The prevalence of diseases such as cancer and heart ailments are increasing, and these disease areas are progressive. Considering the ever-changing and dynamic disease environment in India, it is likely that players will step up investments in the country.

In addition, we are witnessing a rise in disposable incomes which is enabling better affordability of drugs. Moreover, government spending on healthcare has increased and is enabling greater access in Tier-II and rural markets. With COVID, preventive medicine has been put into the spotlight. The acceptance of preventive medicines like vaccines is only going to increase in the future. These are some of the growth drivers which make India a valuable market.

Additionally, the regulatory landscape is witnessing a progressive change. The government’s sharp decision-making and working towards patient safety, empowering the industry equally, is very encouraging. The expected revisions in the DMRC Act, Patent Act; the policy push on Rare Diseases, the OTC framework; the increasing focus on quality in manufacturing, are all pushing the industry in the right direction.

Lastly, skilled manpower and talent, and a robust manufacturing set-up make India one of the most favoured pharmaceutical markets in the world.

With respect to life-saving drugs and preventive vaccines, where does India stand at the moment? What more needs to be done to improve in this segment?

India is the third largest producer of pharmaceuticals by volume and the largest producer of vaccines globally. As a nation, we have not only made great strides in making important medicines and vaccines available across the country but are also able to help other countries with life-saving medicines in times of crisis.

The Government is taking significant steps to improve access to life-saving medicines through schemes such as the Pradhan Mantri Bhartiya Janaushadhi Yojana (PMBJP). However, more needs to be done to increase the number of Janaushadhi stores, improve the supply chain for these stores and ensure the availability of life-saving medicines at these stores. The Ayushman Bharat program too is a giant stride in the right direction – one of the largest public health initiatives in the world. Access to the latest innovative treatments and breakthroughs for all citizens should be a priority that can help save lives. This will require a program like AB-PMJAY to also expand its scope and provide access to such innovative and breakthrough therapies to its beneficiaries.

If we talk about the cost and affordability of drugs, there are certain medicines like orphan drugs which cost more than 10 million in India. Why are such drugs costly and what needs to be done in countries like India to improve the affordability and accessibility of such drugs?

Over the past few years, we have witnessed significant advancements in the treatment of rare diseases. To understand the cost of a medication, one needs to understand how and what they are solving. Most of the orphan drugs are categorized as personalized or precision medicine as they treat specific issues basis the unique genetic code of a patient. These medications, being customizable, are usually more effective than some of the conventional treatment modalities. This makes the drug research and manufacturing process expensive. Add to this, the small patient pool which creates challenges owing to a limited scale. As is evident then, orphan drugs (as medications for rare diseases are called) are a result of years of research and development.

Access to such therapies is always based on Government-Private partnerships. This is the model across the world. While companies do put out access initiatives – such as Patient Assistance Programs where drugs are either significantly subsidised or even provided without cost to patients who need affordability assistance, the only sustainable model is for a partnership between the Government and providers to ensure that patients are able to have access to these therapies through national payer programs in a manner that is sustainable for providers and payers alike.

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