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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :UK keen on strong bonds with Indian drug controllers for quality.. 2009-09-21 20:17:13 
Sree
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The United Kingdom (UK), which prides itself in being a major centre for drug research, has great interest in building up a strong relationship with the Drug Controller General of India.

This is not because India is considered a major centre for drug research, but, because about one-fourth of the volume of generic drugs sold in UK are those imported from India.

About two-thirds of the products sold in the UK are generic. “That’s why we are interested in building up a strong relationship with the Drug Controller of India and the respective drug controllers in the major states,” said Gerald W Heddell, director, inspection enforcement and standards division, Medicines and Healthcare Products Regulatory Authority, UK.

The UK’s centralised healthcare system, National Health Service (NHS), is the world’s biggest health service. UK is interested in ensuring that they have only quality products being imported.

The UK government wants strong links with the Indian regulators. That is one reason why Indian drug producing companies are also of great importance for the UK.

A team from the UK was in India to exchange information with the Drugs Controller of India and also some of the state drug controllers.

Meanwhile, the UK, which has great strength in clinical research, is trying to attract clinical research firms from India to set up labs or for doing clinical research in the UK. It is also keen on promoting itself as a drug manufacturing centre.

According to a report from Ernst & Young 2007, UK was the leader in biotech sector in Europe with 40 per cent of EU’s public biotech companies.

The UK has established end-to-end capability in bringing products to market.

It accounts for about 35 per cent of the European drugs in clinical trial pipeline. In the UK, the government funding for clinical research is expected to rise to 1.7 billion pounds per annum by 2010.
 
 
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