Recently appointed as Director General of the Pharmaceuticals Export Promotion Council (Pharmexcil), Uday Bhaskar’s experience spans various government departments and has the unique expertise to understand industry’s issues as well as regulatory affairs. In an interview with Usha Sharma, he shares his experience and plans for Pharmexcil
So far you have largely been associated with government departments working on the other side of the fence. What are the learnings you can implement from your past experience to create a more cohesive environment within the Council?
All my earlier assignments with the government were in different capacities to enhance the efficiency of our industry through a different responsibility and enforce the legislation. As a regulator in the state government, I was playing a key role to improve our industry’s regulatory compliance by closely watching the industry and finding ways and means to improve their efficiency and mentor them to adopt such practices to keep pace with developments in regulatory affairs all over the world.
As I was the Secretary General of All India Drugs Control Officers Confederation (AIDCOC) for the past 12 years and President for four years, I know the issues of regulators and industry. I have a vast experience of organising interactive meetings of industry – regulators to update the knowledge on latest development in the regulations. We (AIDCOC) have closely worked with the industry to represent the issues of industry and regulators to the government. With my regulatory background, I can understand the issues of the industry and can coordinate better with regulators in resolving those issues.
Now heading Pharmexcil, my responsibility extends to facilitating India’s exporters to find overseas markets. We take delegations to various markets. In the course of conducting this primary responsibility, Pharmexcil may have to advise the industry to adopt certain changes in the standards of GMPs. Besides, sometimes my role would be to help the industry to reach that stage by playing a liaisonary responsibility between them and government and/or between our exporters and foreign regulatory agencies, to resolve issues, if any, while the industry is adapting to the requirements of our clientele.
What are the new initiatives you intend to commission to boost Indian pharma exports
Now that the basics of an export systems having been set up, Pharmexcil would look into the newer challenges. Like more joint ventures, and to facilitate more foreign direct investments (FDIs), especially export-oriented ones, to try and find methods to get a proper breakthrough in certain difficult markets adopting the methods described.
With the support of Department of Commerce, in collaboration with the industry, national research institutions like IICT, NCL, we have also initiated steps to develop strategies to reduce dependence on imports of intermediates, key starting materials (KSMs) and active pharmaceutical ingredients (APIs). Pharmexcil has also established an innovation desk headed by a senior scientist and formed a ‘think tank’ with representatives from BDMA, IDMA, IICT, NCL and senior people from industry.
Till the last financial year, Indian pharma exports were declining. However, in the last quarter, the growth momentum has been revived. What are the factors which have brought about this change?
In the last financial year (2015-16) our exports has grown by almost 10 per cent. For the most part, we operate in the generic sector of exports. The global generic market during the corresponding period has grown only by four to five per cent. Our generic exports have been continuously growing more than two times the growth rate of global generic market which indicates that India’s generic share has been continuously improving.
In the financial year 2016-17, our generic exports have just touched the global generic market’s growth rate. This reduced performance is due to the fact that globally generic prices are coming down and many governments are imposing price controls on this sector. In-spite of our exports in terms of volumes has shown considerable growth, we could not register desirable growth by values.
The fact that during the last quarter of the calendar year 2016, India companies have bagged the highest number of ANDAs (almost 34 per cent of the total ANDAs granted in this quarter ) gives a lot of hope that India’s generic exports would be on course in the coming years.
Political uncertainty has created a lot of upheaval in global pharma markets. How will the Council help the industry cope with these challenges to keep up exports?
This would be a temporary phenomenon and most of the issues, except devaluation of currencies of certain countries vis-à-vis the US dollar (for example, Nigeria, and some other petroleum dependent countries of Africa and other continents), do not affect pharma exports. Exceptional growth which we normally experience in big markets like the US and Europe (for example we have registered over 10 per cent growth in exports of generics to the EU even in 2016-17 so far) would offset this decrease and keep a balance in such situations.
Which countries do you think Indian pharma companies should look for growth and why?
On the face of it, Indian pharma companies are looking at the entire global market place for growth in various therapeutic areas. Pharma companies would look for opportunities in finished formulations, APIs and intermediates besides emerging areas like excipients, bio-similars and medicals devices.
Let us look at the answer from a different perspective. The global market place can be divided into three categories. Highly regulated, regulated and least regulated ones. The dynamics of regulations moves progressively towards more regulations as factors like emergence of local manufacturing, political sentiments, competition and many other such variables become determinants of the directions of market forces.
The first way is to look at the market strategies of large companies. These companies look for growth and more consolidation in highly regulated market as the returns are high. The US, presently being the largest export destination having over 30 per cent share of India’s overall pharma exports, will continue to be the market for growth for large companies in their strategic goals. The top companies would be more keen to introduce new products, joint ventures, acquisitions and also opportunities in research and development.
Large companies on the strength of their regulatory compliance would also look towards Japan, presently the third largest market. Japan has opened up its generics market space. By 2018, it strives to increase the share of generics in its healthcare programme to 80 per cent. The highly developed economy is looking for reducing the public healthcare budget. Indian companies have a huge opportunity in Japan. They can explore partners for contract manufacturing and joint ventures.
Further, there is immense scope for API manufacturers. Japan and India signed a Comprehensive Economic Partnership Agreement (CEPA) in December 2011 thereby giving a level playing field for Indian companies at par with Japanese companies. Pharmexcil, since 2012, has been very aggressively promoting opportunities in the Japanese market besides taking every step to create a positive outlook towards Indian companies by engaging with top Japanese innovators, generic companies and regulators. Yes, Indian companies shouldn’t expect relaxation on regulatory compliances in Japan. The companies have to build compliance and capacity for the third largest market.
Countries in the EU shall remain in the strategic landscape for growth of large manufacturers from India in APIs and finished formulations. Areas of biosimilars and new product research will drive growth opportunities. India’s exports to the EU are presently over 21 per cent. In a nutshell, the highly regulated market having 55 per cent share of India’s export will continue to offer opportunities for large companies.
The low-hanging-fruit markets like Africa will be looked at by small and medium-sized companies. Affordability and accessibility of products will be the dominating factors offering opportunities. Some of the African countries have also attracted investment in local manufacturing from Indian companies.
Top pharma companies are consolidating their markets in Brazil and Colombia while medium and small companies are getting good opportunities in Central America and other South American markets.
Notwithstanding issues in Vietnam, it will remain a large market for Indian companies in the Eastern part of the world. Philippines too will be an attractive market place for growth. Government of India’s ‘The Look East policy’ and formulation of more value integration strategy for CLMV (Cambodia, Laos, Myanmar and Vietnam) will provide immense growth opportunities.
How many buyer-seller meets are planned for this year and in which countries?
During the current financial year 2017-18, the Council is organising 12 buyer-seller meets in North America, Germany, Kenya, Myanmar, Peru, Colombia, El Salvador, Brazil, the UAE, Ukraine, Algeria and Nigeria.
Pharmexcil hosts iPhex in Mumbai every year so why is there a shift in location from Mumbai to Hyderabad this year?
The pharma industry is located mainly in the states of Maharashtra, Gujarat, Telangana and Andhra Pradesh. The Council has been organising iPHEX in Mumbai for the last four years, as it is one of the important cities for the pharma industry. Government of India felt that it would be ideal to organise iPHEX in those states where pharma has a strong presence with an objective to showcase the Indian pharma capabilities to promote exports.