Indian pharma views 2013 as an year of both achievements and setbacks. On the one hand, it was an year of several new product launches and on the other industry had to deal with regulatory actions from the US FDA, global economic slowdown and volatile currency fluctuations. However, the outlook for 2014 appears to be somewhat tough because of the slow regulatory clearances of clinical trials, challenges from new Drug Price Control Order (DPCO) and the CDA Bill.

Among the accomplishments were the country’s access to Biocon’s in-house developed monoclonal antibody AlzuMAb which is world's first novel anti-CD6 antibody for Psoriasis. Abbott too unveiled and developed the next-generation Nepro with KidneyCare and CarbSteady, a complete renal nutrition to decrease progression of chronic kidney disease and replace nutrients lost during dialysis treatment.

From the Union government, in May 2013 the National Pharmaceutical Pricing Policy and the new Drug Price Control Order were introduced.

There were also a slew of acquisitions: Strides Arcolab’s subsidiary, Agila Specialties India and Agila Specialties Asia bought by Mylan Inc. Elder Pharma’s generic business sold to Torrent, GlaxoSmithKline Pte., Singapore subsidiary of GlaxoSmithKline Plc increasing its stake into GSK Pharma India by 24.33 per cent.

Globally, AstraZeneca’s agreement to acquire Bristol-Myers Squibb’s diabetic portfolio.

There were investments initiatives like GSK’s Rs. 864 crore outlay in India for a manufacturing unit. Anthem Group’s Rs. 100 crore for a second production facility at the Harohalli Industrial Area, Bengaluru. Biocon partnering with Keck Graduate Institute, California to open Biocon Academy, Centre of Excellence for Advanced Learning in Applied Bio-Sciences. Stabicon Lifesciences’ Rs. 6 crore for a Greenfield contract research unit. Medreich efforts on two Greenfield projects.

While Kemwell successfully went through USFDA inspection for its Oral Solids unit in Bengaluru, Ranbaxy, Wockhardt, Glenmark, Hospira received warning letters from the regulator.

According to Sujay Shetty, Leader: Pharmaceuticals and life sciences, PwC India, 2013 was driven by regulatory reform and the desire to rein in healthcare expenditure; many developed countries have increased the use of generic products. These efforts led to increased opportunities for Indian companies and exports showed robust growth. Many Indian companies launched new products in global markets. Depreciation of Indian rupee vis-a-vis major world currencies has also aided the export growth.

Growth in the domestic market however slowed down considerably to 9.8% in 2013 from 16.6% in 2012. DPCO 2013 had an impact on the topline growth of companies. Challenges with product offtake by stockists and introduction of free medicine schemes in some states also impacted growth. Delays in approvals for clinical trials as well regulatory issues like restriction on FDI in pharma, uniform code for sales and marketing, compulsory licensing have also had an adverse impact, noted Krishnakumar Sankaranarayanan, Associate Director, Pharmaceuticals and Life Sciences, PwC India.

Looking ahead in 2014, Indian pharma will look to redesign product portfolio driven by price control requirements. Industry will look to take advantage of biosimilar opportunities. This would see companies to renew focus on quality manufacturing norms. Besides, efforts to enhance productivity of sales forces, improve supply chain efficiency and enhance compliance with information technology will play a major role to achieve these objectives, noted Shetty.