Updated on 29 May 2013
He identified that the main reason such cases resurface is because Indian companies follow FDA norms only because they are forced to. "If you do not follow norms in full spirit, then such cases are bound to come up. Most companies adhere to the US FDA norms because they need the certification to sell in that country. They are not conducting audits and checks to help improve quality. There is a fear psychosis in the industry now as growing in the Indian domestic market would be difficult for the next three-to-five years. With US being the core market for Indian companies, their fear is well justified," he added.
India's pharmaceutical exports are poised to rise to about $20 billion by 2020. Indian generics account for a 30 percent share of the US market, as per recent industry reports. India currently products more than 20 percent of the world's generics and features among the top 20 pharmaceutical exporting countries.
The Organization of Pharmaceutical Producers of India (OPPI) believe that the additional scrutiny on abbreviated new drug applications (ANDAs) from India would lead to more delays in drug approvals. Mr Tapan Ray, director general, OPPI, said in a press briefing last week that, after recent incidents India's image as a low-cost generic drugs manufacturer could be adversely impacted. "In the backdrop of such high-decibel quality concerns raised by US FDA, the level of apprehension regarding the effectiveness of generic drugs made in India may increase, unless some tangible remedial measures are taken forthwith," he added.
Even as the Indian industry grows in the US, other competitors are soon making their way to the top. Cases such as these might give these foreign competitors a much needed chance to cash in on the quality concerns. Mr D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA), said that competitors in the US generics market would use these recent episodes to reduce demand for Indian generic versions in the market there. "There would be a collateral damage. Other large generic makers could create propaganda against Indian copycat drugs, through their connections with practitioners and other related parties," he said.
While the industry still awaits the effects of these controversies, many have already jumped into action, ensuring that their quality control methods are improved so as to not lose out on competition.