Pharma major Wockhardt Ltd has said it is increasing investments in R&D, looking at expanding markets and launching new products to accelerate growth. “We have always believed that R&D is the key to the future. Naturally, we continue to increase our industry-leading investment in R&D as a percentage of total sales every year,” Wockhardt Chairman and group CEO Habil Khorakiwala said at the company’s annual general meeting (AGM).
“In FY’16, our R&D spend of Rs 669 crore at 15 per cent of total sales is almost 30 per cent higher than our investment in R&D of Rs 515 crore at 11.5 per cent of total sales in FY 15,” he said.
The company has various drugs at different stages of development, he said, adding: “We expect that in the next 3 to 5 years, we will have launched some of these drugs in Indian and global markets. Collectively, we are serving diverse patients with unmet needs comprising a global antibiotic market estimated at USD 40 billion, which we see as an opportunity”.
Wockhardt filed 17 ANDAs with USFDA and has received 2 approvals in 2015-16, with 84 ANDAs pending overall.
“We are constantly seeking to grow our business, expand our markets and launch new products,” Khorakiwala said.
In the last 10 years, global research in antibiotics has declined and the number of patents filed globally has gone down by 60 per cent. While during the same period, Wockhardt has continued to invest in R&D and the number of patents filed by it has gone up by 600 per cent.
In 2015-16, the company’s US business declined by 11 per cent and EU market declined by 11 per cent. India business grew by 16 per cent where the company launched 48 new products.
On USFDA inspection, Khorakiwala said that significant resources deployed to enhance and streamline processes to ensure regulatory compliance has yielded encouraging results. During 2015-16, its L1-Chikalthana, Aurangabad, facility was inspected by UK MHRA and they have issued an unrestricted GMP certificate.
Accordingly, supplies have been resumed from L1 facility to the UK market.
USFDA has completed inspections of the company’s manufacturing units at Ankleshwar, Gujarat, and Shendra, Aurangabad, and made observations that have been duly responded to.
The Shendra manufacturing unit is a new facility supplying to India, UK and Irish markets. The company is not supplying any product from the Shendra facility to the US market. “Besides, our manufacturing facility at Waluj has received the Establishment Inspection Report (EIR) from US FDA.
“We are committed to achieving full regulatory compliance and have initiated and implemented several programmes towards this objective,” Khorakiwala said.