Hyderabad: The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s drug regulator, said it is working on moves towards a “greater degree of acceptance" by other countries.

The move is aimed at reducing the duplication of inspections and helping regulators speed up approvals.

Around 29 countries in Europe endorse MHRA good manufacturing practices (GMP) certifications.

“We are working on programmes of sharing inspections, hoping to move towards greater degree of commonality and sharing between inspectors," said Gerald W. Heddell, director, inspection, enforcement and standards division.

The UK is the world’s 10th-largest pharmaceutical market, estimated to have been worth $21 billion (around 1 trillion today) in 2011, according to market researcher IMS. Generic drugs make up two-thirds of the UK market and a quarter of it is imported from India in volume terms.

On average, MHRA inspects about 50 facilities in India that are directly related to products manufactured for the UK market to check compliance with good manufacturing practices.

India has about 160 MHRA-inspected manufacturing facilities, making it the second-most inspected country after the US.

Several developed country regulators have stepped up inspections as they move towards greater dependence on low-cost imported generics to reduce their ballooning healthcare expenditure. These inspections sometimes overlap with each other.

The US Food and Drug Administration (USFDA) has opened offices in India to keep up with the pace of regulatory oversight.

MHRA said it has no intention to set up an office in India but is looking at “working with other agencies trying to find ways of sharing", Heddell said.

MHRA is also working with the Indian drug regulator in terms of capacity building through joint inspections of sites and training of drug inspectors. “A lot of these regulators share reports of their inspection nowadays because they are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)," said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance.

PIC/S is an alliance of countries and pharmaceutical inspection authorities for cooperation in the field of GMP. Around 41 regulators from mostly developed nations are part of the alliance to promote harmonized GMP standards.

Shah said India should join PIC/S in order to benefit by sharing the experience of regulators from the developed world.

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