The first drug being jointly developed by GlaxoSmithKline (GSK) and Dr Reddy’s Laboratories will be filed for registration in this year.
Speaking to newspersons on the sidelines of the ongoing BioAsia 2014 here on Tuesday, Rogerio Ribeiro, Senior Vice-President & Head of Emerging Markets and Asia Pacific, GSK, said the registration would be initially done in Europe. “We will be introducing the product through Europe in the emerging markets which has been a focus area for us,’’ he said. Generally, it takes a couple of years for a product to hit markets after filing for approval.
While hinting that the product could be in the cardiovascular segment, Ribeiro declined to give any further details on the product, but said it would be different from the new chemical entities being developed by the Hyderabad-based pharma major.
When asked about the business plans for India, he said India, along with the other emerging markets was a key region for the company, and GSK was committed to invest in India. Though there were some concerns such as fluctuations in exchange rates, the company has a long term view as it would account for 25 per cent of total pharma business of the UK-based multinational firm.
“We have a strong pipeline of products which would also take emerging markets in to consideration,” he added. GSK was also working on its malaria vaccine. “The first vaccine should be available in sub-Saharan Africa in 2016,’’ Ribeiro said.
Clinical trials On the adverse impact of pharmaceutical pricing policy for essential drugs introduced last year in the country, he said: “There is short-term impact but the pricing policy in aligned with our philosophy.’’
Referring to present regulation on clinical trials in India, he said every country would like to have clinical trials conducted on their own people, own land and to have its own regulation. “