The Hindu Business Line : Glaxo wants norms relaxed for non-patented molecules import

GLAXOSMITHKLINE'S (GSK) collaboration with Ranbaxy Laboratories to jointly develop patented drugs has hit a roadblock, with the Government not permitting import of some lead-molecules needed for research.

Speaking to newspersons at the sidelines of a conference on Building Innovative Pharma in India organised by the CII, Dr Tachi Yamada, Chairman and Head - Research & Development (R&D), GSK said, "We are facing problems trying to ship in some chemicals. Since these are lead-molecules, there are no patent filings or publications. The Government at present does not permit the imports of such molecules." He hoped that the Government would take care of the problem.

Ranbaxy and GSK had last year entered into an R&D alliance covering several therapeutic areas including urology, anti-fungal, anti-bacterial, diabetes, inflammation and asthma. While GSK would provide the hits (potential molecules to be developed as drugs), Ranbaxy would undertake the initial research, development and clinical work. Once a compound is selected as a development candidate, in most cases, GSK would complete the development process. GSK would have the commercialisation rights worldwide, while Ranbaxy would have it for India.

Dr Yamada also said that GSK is looking at more research pacts with other Indian pharmaceutical companies for drug discovery and development. "We are considering all types of research and development collaborations with different pharma companies in India. We cannot ignore India, but there are regulatory issues to be sorted out before striking any new agreements." He added that the issue of Intellectual Property Rights needed to be addressed.

The company is looking at outsourcing in the areas of clinical research, data management and process chemistry. "We are planning to offshore one-third of our clinical trials to low-cost countries in the next two years and India comes under that banner," Dr Yamada said. He added that India has several plusses including a broad scientific capability, entrepreneurial culture and language advantage over other countries.

India has the potential for low cost solutions and GSK would like to take advantage of that. However, quality was also crucial. It is estimated that the cost of conducting clinical trials in India can be as little as a tenth of the costs in the West. Currently more than 90 per cent of GSK's human trials are conducted in the West. In the United Kingdom, a healthy volunteer would be paid about 100 pounds a night for a typical study.

Earlier, Dr R.A. Mashelkar, Director General of Council of Scientific & Industrial Research (CSIR) said that despite lower R&D budgets, Indian scientists should learn to think out of the box. He said that a new drug for psoriasis is being developed, which would bring down the cost of treatment drastically.

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