P.T. Jyothi Datta
Nashik, Feb. 22
GLAXOSMITHKLINE Biologicals (GSKB) plans to manufacture vaccines at its planned facility in Nashik, Maharashtra.
Till date vaccines for the Indian market are developed, produced, filled and packaged at the company's vaccines headquarters in Belgium. The plant at Nashik would be a vaccine filling and packaging unit and is located at GSK's existing pharmaceutical facility.
Vaccines is an estimated Rs 100-crore business for GSK in the country, where the private market is about Rs 300 crore. The new facility marks a milestone as the parent company takes its manufacturing plants outside Europe, closer to markets that need the vaccines, said Mr Patrick Florent, GSKB's Vice-President, Global Industrial Operations Biologicals.
Details on the financial investment in the new plant were not divulged, but the plant expects to commence operations by the second quarter of 2006, said Mr S. Kalyanasundaram, Managing Director of GSK in India.
Outlining the company's vaccine plans for the local market, he said, that a range of paediatric vaccines were awaiting regulatory approvals here.
Infanrix hexa, a six-in-one combination vaccine that immunises against six diseases is likely to hit the Indian market by the second half of next year, he said. The vaccine would have to undertake clinical trials, or testing on humans, before that. Similar regulatory approvals to conduct clinical trials are expected for vaccines against diseases like rotavirus related to gastroenteritis. Another innovative vaccine for cervical cancer expects to get European regulatory clearance by end-2005.
Similar clinical trials are expected to start in India this year and the product is slated for the local market in 2007, he said.
India will be part of the network of new vaccines from the company, said Mr Jean Stephenne, GSKB's President and General Manager, during a video-conference.
Commenting on the pricing pressures on vaccines in the local market, Mr Sundaram said that GSK would have a mature portfolio of products, 10 years down the line, with new vaccines at a higher price and a middle and lower segment of vaccines that were more affordable. GSK was forced by local competition to drive down the price on its Hepatitis vaccines.
Mr Sundaram said that the vaccines facility would be under GSK's 100 per cent subsidiary, while marketing would be done by the listed entity, GSK Pharma. It is a sale and purchase arrangement and there will be no royalties involved, he said.
GSK's top brass were at Nashik for the foundation stone laying ceremony of the new facility.
Mr Florent said that GSK also had vaccine packaging facilities at Russia and China through joint-venture companies.
The Indian facility would commence with production of DTP and Hepatitis B vaccine combination, Hepatitis A and B vaccines, respectively.
GSK officials opined that a local facility did not give any pricing advantage, unlike the pharma model. The advantage, however, is that it gives flexibility and responsiveness to the supply chain, Mr Florent said.