Mylan is the world’s second-largest generic drug player in terms of revenue. However, the behemoth is yet to make inroads into the Indian market. The company entered India in 2007 with its buy of Matrix Laboratories. Since then, it has espoused the inorganic growth theory. Mylan’s India arm now constitutes nearly 50% of its global employee strength. President Rajiv Malik, who oversees Mylan’s R&D activity as well as regulatory affairs, manufacturing and quality, spoke to Pallavi Ail on why the company is cautious while negotiating Indian pharma waters. Excerpts
How important are the India operations to Mylan’s global business?
We entered with Matrix Labs’ acquisition. Mylan had about 1,800 people in India at that time. Today, we are about 12,000. Mylan has close to 20 sites between API, finished dosage, solid and injectables. With close to 1,100 people, we have a very strong research and development team in Hyderabad and Bangalore.
It’s very difficult to quantify India’s contribution to Mylan’s total revenue as the country contributes in many ways. It is a global hub for R&D, supply chain and even an export base for emerging markets. Close to 50% Mylan employees are in India. We have invested heavily in India over the last four years, pumping in about $0.5 billion to build state-of-the-art facilities. So, India has been the epicentre of action.
Why hasn’t Mylan concretised its presence in the India market yet?
We would like our play here, but we have not been aggressive since the Indian pharma market has been transitioning in the last couple of years. But we have been steadily building our portfolio.
Which therapeutic areas are you looking to enter next?
We launched our anti-retroviral (ARV) portfolio two years ago because it was a good base to start with. Mylan has a strong ARV play. We added about 200 people in the field force. Then, we expanded to women healthcare in the second year. After that, we added critical care and oncology. We will continue to launch more therapeutic categories. Respiratory and gastro are two other areas we are looking at.
In 2013, Mylan bought Agila Specialities, whose manufacturing facilities are now under the USFDA scanner. What do you think of the compliance-related issues that Indian units face?
Agila has given us a platform to be recognised as a serious injectables player. Our asset purchase is not ruled just by the financial component, but mainly by the strategic component.
In terms of FDA scrutiny, every risk is an opportunity. We believe the industry has to go through this transformation — it will come out stronger. The FDA has overnight changed its own yardstick for quality, but the industry needs to step up, which it is doing. I expect it to respond very responsibly.
There is no workforce better than the Indian workforce. What’s important is how much we invest in training. It helps them not only understand but also appreciate what standard operating procedures mean — that’s where we need to do rigorous work. I don’t think it’s a cultural issue. It’s a gap we have from the training point of view.
What’s your opinion on India’s drug pricing regulations?
I feel market dynamics should gain control of pricing. I understand the role the government wants to play — providing medicines to millions who do not have access to them. That’s the government’s key responsibility, and the industry should do its bit too. We can have a balance between the two. The interaction between the industry and the regulator needs to evolve.