It is imperative for companies today to identify new engines of growth and invest more in innovation: Dilip Shanghvi

The complete speech of Dilip Shanghvi as President of 70^th Indian Pharmaceutical Congress being held from December 21 to 23, 2018 at Amity University, Noida

Good Morning!

It gives me immense pleasure to welcome all of you to the 70th Indian Pharmaceutical Congress. We have all gathered here today to showcase and commend the remarkable contribution of the Indian Pharmaceutical Industry and Academia. A glance at the list of presentations, planned for the next three days, reveal the amazing diversity of research and innovations in the pharma sciences. The next three days will enrich us on topics ranging from APIs; generic formulations; diagnostics and medical devices; to biosimilar; pharmacovigilance; clinical research; herbal drugs and many more.

The global spending on medicines is expected to reach over $1.4 trillion by 2022, growing at an average compound annual growth rate (CAGR) of 4.38 per cent from $1.13 trillion in 2017. India is known globally for being a leading supplier of quality, affordable drugs to more than 200 countries. It has the highest number of USFDA approved plants, outside the USA. India accounts for the second largest number of Abbreviated New Drug Applications (ANDAs) and is global leader in Drug Master Files (DMFs) applications in the US. India also has second largest share of pharma and biotech workforce in the world. Overall market opportunity remains large for Indian pharma companies. While in developing nations, market is characterised by high per capita spending, high availability and access to life saving drugs, however, this is not the case for developing countries. Demographic changes in population and advances in medical treatments are expected to translate into a rise in per capita spending in developing nations. Innovation in medicines, along with economic progress, will result in a rise in volume as well access to medicines.

In the past few years, our Government has been actively working to make healthcare more accessible to the people of India. Initiatives such as ‘Ayushman Bharat’ and ‘Jan Aushadhi Kendra’ are good examples in the regard. The ‘Make in India’ initiative of the government has indeed been most successful in the field of pharma. Other initiatives like ‘Kaushal Bharat Kushal Bharat’ for skill development and ‘Digital India’ are also promising and innovative ways of strengthening pharma industry in the country.

While we all are proud that every third tablet in the world is ‘Made in India’ however, the pie of the pharma business captured by Indian pharma companies in terms of dollar value is very small. The Indian pharma market is the third largest in terms of volume and thirteenth largest in terms of value. To put things into perspective, Indian pharma industry registered sales of value. To put things into perspective, Indian pharma industry registered sales of $36.7 billion in 2017, while overall global market was $1.13 trillion in 2017. It is expected to grow at a compound annual growth rate (CAGR of 22.4 per cent to reach $ 55 billion by 2020. Indian pharma industry has till date focused on generic medicines, wherein we have been able to garner high volume share, however, have lagged behind in market share in terms of dollar value. We are global leader in quality generic drug manufacturing, however, we are yet to develop a strong, research-based pharma industry that can produce innovative medicines. We need to undertake several initiatives across infrastructure, regulatory framework, and human resources etc. to place India as preferred destination for pharma innovation.

With changing global landscape, it is imperative for companies today to identify new engines of growth and invest more in innovation. It is a good sign that some of the companies are already trying to move up the value chain and investing in innovative specialty and complex generics products. In order to build an ecosystem of innovative products coming from Indian pharma industry, it would require some early adopters to taste success with innovative products, for others to follow the suit and invest, since this would require long term commitment. This would require Indian entrepreneurs and pharma companies to augment their capacity and capability for driving research, development and manufacturing of innovative products.

Adequate regulatory framework, commensurate with the global standards is required to support investment on innovative products and expedite per-clinical research, clinical trial and launch of new drugs. Time-bound implementation of policy interventions is a prerequisite for India to realise its innovation potential and vision. New medicines require extensive clinical trails to demonstrate safety and efficacy. Clinical trial activity in India is lower than that in other BRIC countries and several other developing nations.

Lengthy approval processes and timelines and available infrastructure pose a significant challenge in terms conducting clinical trial in India, hence several companies prefer to do clinical trials outside India in order to bring their drugs faster to market. Since companies don’t pursue clinical trails in India, it hampers clinical trial capability building at our medical institutions, hospitals as well as for medical practitioners and others involved.

In order to promote innovation, Government is working towards bringing suitable regulatory frameworks and taking steps to strengthen the capability of our regulatory agencies. We have already started moving in the right direction, with Government seeking comments on draft amendments in Schedule M (Good Manufacturing Practices), Pharmacovigilance System Inspection Guideline and New Drugs and Clinical Trails Rules.

Co-ordination between Central Regulator, which approved new medicines and State Regulators, which grant manufacturing licenses as well as conduct inspection, also have to be strengthened in order to streamline time required for any new drug approval. Augmentation of physical infrastructure in terms of testing laboratories, of central and state regulatory authorities are also of utmost importance,in order to ensure that drugs manufactured in India, whether consumed in India or exported, are safe, efficacious and meets global quality standards. Moreover, regulatory bodies need human resources with adequate technical knowledge on innovation, in order to approve or disprove innovations, as well as to comply with global quality standard. Agencies have already started hiring manpower with suitable technical knowledge and additional skill sets. In order to ensure global recognition of product quality, Government desires to become a member of Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Academia and industry are two important pillars of our economy. A robust collaboration between the two will augur well for developing our economy, enabling innovation and growth in the education system and producing an employment-ready workforce. We need skilled workforce equipped with the right knowledge. The curriculum and syllabus at Pharma Graduate and Post Graduate level should continuously be upgraded in line with newer regulations, guidelines, innovations and research, to keep it relevant and contemporary. Compared to other countries, India has been behind in quality research output both in terms of publications as well as citations. There is a need for improvement in the quality of our research output as well as better transfer of knowledge and technology between industry and academia. Industry R&D Centers are better equipped in terms of latest infrastructure, a better partnership between Industry and Academia will help in bringing out better quality research outputs from our students.

Price regulations by governments and reimbursement pressures in regulated markets may impact adoption of novel medicines as well as innovation of new medicines. Hence, it’s important for Industry and Academia to collaborate in order to bring down the cost of innovation and bring novel medicines in the market. Industry and educational institutes need to build a constructive framework for collaboration to make India a global innovation hub.

In summing up, with the existing calibre of Indian pharma sector, newer advances in research, industry-academia partnership as well as economic driven government policies, will take the Indian pharma sector to newer heights and support innovation.

Last but not least, I encourage you to visit the Expo, showcasing latest developments in pharmaceuticals, technology and machineries.

Also, allow me to thank our Guest of Honor, as well as those who encourage us in one way or the other, and contributed towards successful opening of this Congress. I would also like to thank all the participants, especially those who came from abroad, for joining us and sharing their valuable experience and ideas.

I sincerely hope that this 70^th Indian Pharmaceutical Congress act as a collaborative platform for sharing of information, ideas and encourage innovation. I will close my address with the famous saying of Hippocrates – “Wherever the art of medicine is loved, there is a love of humanity.”

Thank you,
Dilip Shanghvi
President – 70^th IPC