Indian Pharma's Big Leap

Drug companies are moving up the value chain, transforming into complex generic manufacturers with high end R&D facilities.

- P.B. Jayakumar

Nagpur-based Zim laboratories is a nondescript drug company with turnover in excess of `250 crore. In the past two decades, Zim has been silently working on developing innovative and differentiated pharmaceutical products or specialty generic complex drugs. Recently, it developed a new product, Orally Disintegrating Strip (ODS) formulations up to 100 milligram, based on a patented oral thin film technology. These films, when placed on the tongue, adhere to the tongue mucosa and disintegrate almost instantaneously. There are only some 10 companies across the globe with this technology, but they are not able to grab a big share of the market due to prohibitive manufacturing costs. “With our technology, we can offer thin films at a price near to that of an oral tablet,” says Anwar S. Daud, Managing Director of Zim Laboratories.

Zim is in advanced stages of further researching the product to launch thin films with fixed dose combinations and liquid drugs, 3D printed tablets for personalised medicines and nano-fibre-based thin films. If Zim is a small player doing such cutting-edge research and development (R&D), most of the Indian drug majors are now doing the same on a large scale. In March, the US Food and Drug Administration (USFDA), approved the first two generic versions of cinacalcet hydro chloride (Sensipar) tablets for the thyroid treatment of dialysis patients. Both those companies were from India – Cipla and Aurobindo. Amgen’s Sensipar generated $1.72 billion in revenue for it in 2017 and comprises 7.5 per cent of its total annual earnings. Now consider the example of India’s leading drug company Sun Pharma. The company’s shares rose 6.4 per cent on December 27, touching a five-month high, after the USFDA accepted its new drug application for a complex product OTX-101 (cyclosporine A, an ophthalmic product).