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European Pharmaceutical Contractor

Trying Times

The US National Institute of Health (NIH) recently decided to suspend all clinical research operations in India. In the West, we have always had something of a divided opinion when it comes to running clinical trials in India. However, when compared with other developing nations, India is considered to have one significant advantage: English is an official language and spoken by virtually all educated people.

As a result, India has previously rated highly as a suitable country for outsourcing trials. The disillusionment of the NIH with India as a clinical trials location follows the disillusionment of many people with the use of Indian call centres, to such an extent that many organisations now promote the fact that their call centre is located in the UK as a customer benefit.

Unfortunately, over the past few years we have seen a rising number of reports regarding unsafe practices taking place in Indian clinical trials. Both the US Food and Drug Administration (FDA) and the European Medicines Agency have conducted numerous inspections. In India, in response to a growing amount of manufacturing violations, the FDA has announced that its scrutiny – and hence its activities – will increase. It is also expanding its overall presence in India by exploring the possibility of setting up a third office.

FDA inspections on clinical trials started in 2005, and by 2011 some 30 inspections had been carried out. These covered 10 therapeutic areas, Trying Times with a particular focus on psychiatry. The results were encouraging: 53 per cent of cases required no action, while 47 per cent had voluntary action initiated, but no official action was ever required by the FDA. The most common deficiencies involved drug accountability, failure to follow investigational plans, and inaccurate or incomplete recording of data. So far so good.

Over the last 10 years, the regulations covering clinical trials in India have been progressively tightened. The number of trials in the country peaked in 2010, when as many as 500 trials were granted approval, followed by 325 in 2011, and 262 in 2012. The Supreme Court subsequently intervened to better regulate clinical research in India after it emerged that 2,262 people had died in trials over the previous five years, resulting in public uproar over using Indians as ‘guinea pigs’ in pharmaceutical trials. So far not so good.

The new regulations sought to remedy some of the problems, but the advantages of India will start to lose their appeal if companies continue to follow the lead of the NIH. The Times of India reported that several US and Canadian companies have stopped clinical trials in India following an amendment to these regulations, which they say could lead to ‘unreasonable claims’ by subject-patients. The new rules – brought in by the Directorate General of Drugs Control in India – make it mandatory for companies and educational institutions to meet all medical expenses for those who volunteer for clinical trials.

The pessimistic French expression plus ça change, plus c’est la même chose (‘the more things change, the more they remain the same’) is very often cut down to just the first clause: plus ça change. In both French and English, the phrase indicates a certain disillusionment or resignation regarding whatever is being talked about. A decade ago there was considerable uncertainty over the possibility of running trials in India; however, a boom followed as the advantages were seen to outweigh the risks. This was succeeded by another surge of mistrust, then by new regulations, and now we are experiencing the debate all over again.

India still has huge advantages over running trials in the West. In my view, the greatest of these is the availability of patients who are often drug naïve. This means that recruitment can be very rapid. Cost advantages are also clear, but the mistrust I mention will increase prices as more monitoring and stricter audits become routine. It seems that, at the moment, disillusionment is the order of the day, and a huge potential resource will be underexploited (in the best sense of the word) for the time being. Plus ça change indeed!

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