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P.T. Jyothi Datta

Mumbai, Sept. 17 The United Kingdom Medicines and Healthcare products Regulatory Agency (UK-MHRA) is not setting up office in India just yet, but there could be more frequent interactions at the regulatory level.

The MHRA has internally considered whether to set up permanent office in India. “At the moment, we think that is not the right solution for us. What we would prefer to do is to make sure that we have frequent high-level representation in India,” the MHRA Chief Executive, Prof Kent Woods, told Business Line. It is more efficient to co-ordinate with contacts in India, than set up office here, he added.

The UKMHRA is the government agency responsible for the safety of medicines and medical devices. It conducts about 50 inspections every year on Indian plants exporting to the UK.

Recently, the United States regulatory Food and Drug Administration (USFDA) set up office in India. India is home to more than a 100 USFDA approved manufacturing plants. “I discussed this with the USFDA, I know they have recently set up overseas offices not just in India, but also in China and elsewhere. One of the meetings I have held on this visit is with the USFDA,” he said, indicating the decision against a base in India was more logistical and expense-related in nature.

“We would only be able to place a small group of staff here. It would be very costly for the agency. And the small group of staff wouldn’t have all the skills needed to advice. We have got inspection staff, enforcement staff, policy staff, licensing staff. We could not actually replicate all those skills in an office in India and therefore it seems better for us to work out of the UK, to make sure we do that in a coordinated and frequent way,” he explained.

The MHRA visit to India is a first, with the high-level regulatory team interacting with representatives of the Union Health Ministry and regulator, the Drug Controller General of India. The MHRA is looking to build a more formal relationship with the Indian regulator, in terms if inspection and pharmaco-vigilance, he said.

In the past MHRA officials have visited India for inspections, but this visit of the MHRA delegation reflects the scale of the Indian pharma industry’s exports to the UK, he said. The exports include generic drugs, innovative compounds, biotech development, he added.

The National Health Service is a heavy user of generic medicines, about 65 per cent of the medicines used in the NHS are generic, he said. The licences issued show that India is the largest supplier of generics to the UK. The marketing authorisations in the UK show about 750 Indian manufacturing sites (making both finished drugs and active pharmaceutical ingredients) are named on licences of drugs marketed in the UK. Though a majority of Indian manufacturing sites exporting to the UK are satisfactory, there have been isolated concerns around quality, Good Manufacturing Practices and storage in the last few months, he said.

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