New Delhi: Sun Pharmaceutical Industries, the country’s most valued drug maker, aims to file 30 applications in the US for manufacturing and marketing of its generic products, said chairman and managing director Dilip Shanghvi.
The company would file these applications along with its US-based subsidiary Caraco, which is facing trouble due to non-compliance of current good manufacturing practice of the US drug regulator.
“This year too, we intend to file 30 Andas in the US across the two companies,” Shanghvi said in his speech to the shareholders of the company during the annual general meeting held recently.
We continue to spend for product development and file new products from these sites in India and the US, he said.
Between Sun and Caraco, 111 products are pending with the USFDA (Food and Drug Administration).
An abbreviated new drug application (Anda) is an application for a generic drug approval in the US for an existing licensed medication or approved drug.
The $30 billion-plus US generic market, the largest generic market in the world, is of great interest to all pharma companies across the world with global aspirations.
Last year, generics accounted for 71% of the US pharma market by prescription.
India and the US, the two largest markets for Sun Pharma, together accounted for 80% of the company’s turnover in the latest financial year.
Stating about the Rs36,000-crore pharmaceutical market of India, Shanghvi said market competition has been intense and will continue to remain so in foreseeable future.
Companies with global presence continue to either set up operations or enter into contract manufacturing agreements with companies in India with the purpose of creating a low cost sourcing base for their global operations.
“Over and above this, competition from Chinese companies is on the increase strong effort at enhancing their presence in the regulated markets globally,” he said.
According to Shanghvi, the new patent regime, which was introduced in 2005, is likely to have an impact in the years to come.
“We expect the pipeline of new drugs available for launch to gradually shrink,” he further said.
The recent acceptance of the revised Mashelkar Report, which recommends patenting of incremental changes may be an indicator of things to come. Of course, these are not the country’s best interests in the long run.
Currently, in India the patenting of incremental changes are not allowed under the law.
“This will open up a floodgate of patent applications for rudimentary changes and may result in patent life being extended far beyond what it is worth,” Shanghvi added.