US drug regulator to hold quality requirement workshops across India
The US Food and Drug Administration plans to conduct workshops across India in the next one year in order to sanitise the country's pharmaceutical companies about the changing quality requirements in the American market.
The matter came up during a meeting between chief executives of various drug companies and the US health regulator's Commissioner, Margaret A Hamburg.
Wockhardt Chairman Habil Khorakiwala said the plan to conduct workshops in India is part of the FDA's strategy to let Indian companies be more aware about the changes happening in the US in terms of the requirement for quality.
"One of their (USFDA) objective is to sensitise here in India about these changes. In fact, the USFDA is planning a workshop over the next one year at 3-4 locations to clarify what are the new requirements and what are the expectations of the USFDA", Mr Khorakiwala told reporters here.
During the meeting, which was attended by chiefs of pharma companies, including Ranbaxy CEO and MD Arun Sawhney, Sun Pharma founder and MD Dilip Shanghvi, and Mr Khorakiwala, the Indian delegation asked the FDA team to continue with the high level interactions.
"The second suggestion which was made and she (Hamburg) accepted is that this dialogue at the highest level should continue," Mr Khorakiwala said.
She also accepted the proposal that a delegation of leaders and scientists from India should have interaction with larger group in USFDA so that the issues could be discussed at length, he added.
Hamburg, said the FDA is in the process of reorganising its structure and speeding up the process of approvals. She added that this would help clear the backlog of inspection for Indian drug manufacturers who have applied for approval from the US drug regulator to export their products to the US.
The FDA has taken a series of actions against Indian pharmaceutical firms, restricting their shipments to the US, their largest export market.
The US health regulator on January 23 banned the import of products manufactured by Ranbaxy Laboratories at its plant at Toansa. This was the company's fourth plant to face regulatory action from the FDA, after Mohali, Paonta Sahib and Dewas plants.
In 2013, Ranbaxy had agreed to pay a fine of $500 million to US authorities after pleading guilty to 'felony charges' relating to manufacture and distribution of certain adulterated drugs made at the Paonta Sahib and Dewas units. Another Indian firm, Wockhardt, had its two plants put under import alert by the FDA.
India's pharma exports increased 10 per cent to $14.6 billion during 2012-13, with shipments to the US accounting for about 26 per cent of the total.
India is the largest exporter of generics to the US by volume, with supplies from 35 companies in the country. The nation has around 320 FDA-approved pharma facilities - the largest number outside the US.
