The consent decree between the FDA and Ranbaxy in January 2012 set the tone for another year of regulatory headaches for Indian drugmakers, yet the industry continued to grow. PricewaterhouseCoopers (PwC) reports that exports to the U.S. rose 32% in 2012, although it warns that quality failings could stymie future growth.
Biopharma exports from India to the U.S. topped $4.2 billion last year, PwC reports, with the growth in overseas sales helping manufacturers offset difficulties in their home market. The sustainability of this situation is questionable, though. Last week Ranbaxy reported that FDA restrictions on its manufacturing plants had cratered third-quarter earnings, and the PwC report on the state of Indian biopharma warns that regulatory snafus threaten the whole industry.
PwC places part of the responsibility on Indian regulators. "The regulators need to set the standards at par with the global ones through appropriate legislation. They also have to ensure that these standards are effectively enforced and complied with," the report's authors write. India is planning to spend $3 billion to hire at least 110 new inspectors, in-PharmaTechnologist reported last month, but such initiatives have a patchy record of success. India was due to open an inspection office in China in March, but the project has stalled.
The office was supposed to tighten oversight of ingredients from China, a potential weakness in the quality of Indian drugs. Yet with the government and regulatory officials also struggling with clinical trial delays, marketing guidelines and other issues, inspections are just one of many areas that need addressing. For Indian drugmakers, each is a potential drag on revenue that needs fixing. "While pharma companies focus their attention on measures to combat the growth slowdown, they will need to work with the government and other stakeholders to discuss and resolve regulatory challenges," PwC India's Sujay Shetty said.