FDA bans and regulatory actions against some of India's biggest drugmakers have given the country's reputation for producing high-quality but cheap drugs a black eye, cutting exports in the process. The industry is taking the position that most of the problems have to do with paperwork and not quality, and is launching a public relations campaign to regain its standing.
"Our quality standards are among the best in the world. If a neutral audit is done, it will find our true capabilities and strengths," Ashutosh Gupta, chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil), told Reuters. "We want to fight these issues head on."
To do that, the industry has invited regulators from around the world to visit production plants in the country to see for themselves that things are better than reports suggest, according to Reuters. It is holding a conference this month, with support from the government, to convince customers as well.
Growth in drug exports from India fell to 2.6% in the year ending March 31, about $15 billion. Two years ago it reported a 23% rise in drug export value. A big reason for the decline is because India's largest maker of generic drugs, Ranbaxy Laboratories, has had four of its 5 FDA-approved plants banned from shipping to the U.S. by the FDA over quality concerns, including two in the last year. In fact, its long-running problems have led the company to agree to be sold for $3.2 billion to Indian drugmaker Sun Pharmaceutical, which also had a plant banned. Wockhardt, another big producer, had two plants banned. The publicity from these actions has been used by a group of researchers and doctors in the U.S. to push Congress to consider trade actions.
Gupta dismissed the idea that Indian drugmakers don't meet high quality standards, arguing that the FDA actions were primarily based on problems with data documentation and testing and not quality. Warning letters sent to the drugmakers did address documentation, like whether they were manipulating data to indicate batches had passed quality tests when they hadn't. Sanitation issues were also raised. FDA Commissioner Margaret Hamburg acknowledged during a trip to India that most of its companies had modern facilities that operate at top-notch standards. She said problems with a few facilities have tainted the industry, but also said the country needs to do more itself to ensure that all of its producers make quality a priority.
India appears to be responding, if not to Hamburg's urging, then to the market effects. Over the next 5 years, the government intends to spend 30 billion rupees ($500 million) on industry training for industry workers and state regulators.
Utkarsh Palnitkar, who heads the life sciences practice for KPMG in India, said the campaign to repair the country's tattered image can't hurt, but PR alone won't cut it. "It is not a panacea to solve the problems of the pharmaceutical sector," said Palnitkar, who has a working relationship with Pharmexcil. "You can't do it only by promotion, but focused promotion clearly will help put out the right message."
- read the Reuters story