Wednesday, April 17, 2013

MHRA not to open Indian office but prefers sending expert inspectors: Gerald Heddell

Nandita Vijay, Bengaluru
Tuesday, April 16, 2013, 08:00 Hrs [IST]
The UK based Medicines and Healthcare products Regulatory Agency (MHRA) has not considered setting up an Indian office on similar lines of US FDA which has an India centre at New Delhi. Instead, it has decided to interact with the Indian pharma industry who are seeking MHRA approvals through seminars and discussions, said Gerald Heddell, director of Inspection, Enforcement and Standards, MHRA.

India has 141 MHRA approved plants which is around 20 short of the US FDA certified facilities. “We decided not to open an Indian office because almost every week of the year barring the monsoons phase, MHRA inspectors are in this country. Although, we have a presence, maintaining a small team in India with the necessary breadth of expertise across a broad range of activities would not be easy. However, MHRA prefers to send in its expert inspectors and also often engage in meetings rather than open an India office, Heddell told Pharmabiz.

“Indian pharmaceutical industry has a strong foundation in supply of generic drugs. But the industry may consider moving forward into biosimilars and ultimately into developing more innovative drugs. There are already a number of ongoing clinical trials in phase II and III which is a move in the right direction. The future of India does not lie in generics alone but biologicals and innovative products, he said.

In order to strengthen the relationship with India, the Drugs Control General of India (DCGI) office and the MHRA are in the process of inking a memorandum of understanding. This will bring in a better understanding between the regulators in India and the UK and enable working together.

Recently, the MHRA also brought in the National Institute for Biological Standards and Control and the Clinical Practice Research Data under its umbrella, he said.

Commenting on the recent moves of MHRA including the Innovation Centre, Heddell said that the initiative would help to work closely with the industry and share new approaches to licensing and manufacture ensuing safe and high quality drugs for the benefit of patients.

“The falsified medicine directive to be implemented for APIs from July 1, 2013 is a major piece of European legislation. There are many aspects of it like product security, regulation of some people who broker products and importation of active ingredients with the requirement for a written statement from the regulatory of the country of origin. An official from the DCGI office has assured that, India would be able to provide the written confirmations to this effect,” he said.

“All our audits are triggered by a Marketing Authorisation in Europe or UK. The approval of a Marketing Authorisation in the European system works to a fixed time scale of 210 days from validation of application to agreement. The inspection schedules fit in with those applications. However, it would be vital for a prospective Indian company seeking certification to discuss in advance their intention for our audit. There are no plans to decrease the time frame for application and approval of Marketing Authorisation as it is dictated by the European Commission,” he said.

On the presence of two regulators in the EU: European Medicine Agency (EMA) and MHRA, Heddell said that the MHRA is seen as an ideal and efficient route to enter Europe. “We do more work on behalf of Europe than any of the 27 EU countries. We are the leading agency and so contact with the MHRA is a best way to start to apply for drug licenses in the EU.”

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