30 Per cent of ANDAs approved by the US FDA in the year 2016 are from India

The Pharmaceuticals Export Promotion Council of India (Pharmexcil), is working on a zero-dependent manufacturing mechanism to reduce dependence on imports. The Ministry of Commerce and Industry, through Pharmexcil, has formed a committee to identify drugs imported in huge volumes from other countries, says Ravi Uday Bhaskar, Director General, Pharmexcil, in an interaction with BV Mahalakshmi, on the sidelines of FDD Conclave 2017 held in Hyderabad

What is Pharmexcil’s view on increasing pressure on the generic industry?

Ravi Uday Bhaskar

The generic industry is robust and constitutes 28 per cent of the total pharma market and is growing at four to five per cent CAGR. In 2015, two blockbusters going off-patent has contributed to an increase in the size of the generic market in terms of volume and value. However, we may not see such blockbusters going off patent in the next two-three years. Additionally, we will face price controls in the US. However, governments across the world, especially in the regions of thickly populated Asia and Africa are making efforts to reach a larger percentage of population. This is likely to increase the actual consumption of medicines by volumes. Besides, increased health coverage is being forecasted in the regions of CIS and LAC. Generics may see a flat performance in the developed regions of Western Europe and a very modest growth in North America.

India, being a prime generic source and covering all Anatomical Therapeutic Chemical (ATC) therapies, may be able to balance its product portfolio across continents to achieve modest growth in the prevailing situation and hold on to its premium position. I see a positive trend in the coming years, particularly in the US, as 30 per cent of ANDAs approved by the US FDA in the year 2016 are from India and seven Indian pharma companies are among the top 20 global generic players.

How to reduce import dependence and need for import restriction from China?

Pharmexcil and the industry have combinedly highlighted to the government the need to revamp the capacities of our drugs, intermediates and key starting material industry. The Department of Commerce has also pitched in its support. It is quite possible. We are gearing up to kickstart the project. Pharmexcil has coordinated meetings between stakeholders of the industry and the government recently to focus on some products initially and then expand the portfolio. A zero-dependant mechanism translates into not depending on raw materials from other countries. India imports drugs and pharma products from Europe and China in the form of raw materials as well as finished products for both, domestic consumption and exports. Imports form a big portion of many common drugs such as pain-killers like aspirin and paracetamol, first-line diabetes drug metformin and antibiotics such as erythromycin.

What are the immediate plans to increase exports and the projected growth for the domestic industry?

Pharmexcil coordinates with the industry and the government. All our activities are based on the advice of the industry and directions from the government. Hence, our activities are planned as per prevailing market situations. We are planning to explore potential markets like Central America. We are also trying to penetrate highly regulated and brand-oriented Japanese and Australian markets. We are focusing on AYUSH as well. During 2016-17, India’s pharma exports stand at $16.83 billion. Pharmexcil does not make any projections.

What is the outcome of the recent inter-ministerial committee meeting to reduce imports?

Initiated by the Department of Commerce and Pharmexcil, a think tank was formed with the representatives from industry, CSIR-labs and other research institutions. The think tank identified largely imported/dependent key starting materials (KSMs), intermediates and APIs. It also identified the labs that can develop technology which is commercially viable. The recent inter-ministerial meeting decided to focus more on 60-70 largely imported/ dependent products, where we can manufacture low hanging fruits. The Commerce Secretary requested Pharmexcil and CSIR to submit a detailed project report (DPR) to take the initiative further.

What are the opportunities and challenges in the complex generics segment?

The newer class of ARVs like Integrase strand transfer inhibitors, sophisticated dosage forms like pre-filled syringes, mostly used in management of diabetes but also being extended to antibiotics besides some steroids for intra-articular and intra-thecal use, as well as precise dosage delivery apparatus (inhalers) used mostly in respiratory management are some of the complex generics. These complex generics, on overcoming the challenges in developing them, offer good opportunities as there would be limited players in the market. Super generics was the buzz word in this category, four to five years ago but the time involved in developing these drugs and the difficulty in obtaining market authorisation has dampened the interest in them to some extent. Indian players have representation in both the sections and are now keen on developing the former type.

What is the impact of GST on the domestic pharma industry?

There will not be any serious impact on exports but there will be a slight increase in the price to the consumer. The higher rate of tax on beds, dental surgical chairs, operation theatre equipment and some medical devices will add cost to patient bills. As of now, we feel it may not alter much as direct exports are not affected. Even products imported for exports are given the same benefit of reclaiming the IGST paid.


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