Clinical trials in India need better regulations

There are plenty of controversies surrounding pharmaceutical companies in developing nations, but usually these are related to access to drugs and pricing. In India, the controversy surrounds not access to drugs but the conditions under which clinical trials are run, which have led to an estimated 2,800 deaths between 2005 and 2012.

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Why do companies run clinical trials, and specifically why do they choose to run them in India?

The role of clinical trials

After an initial laboratory phase during which a potential medication or new use of an existing medication is identified, most medications will go through a phase of animal testing to ensure their safety and, if possible, their efficacy.

Eventually, however, all medicines need to be trialled on humans to ensure they behave in the way intended. These will usually start very small; however, they will move on to larger trials as quickly as possible.

Depending on the type of medication and the rarity of condition being targeted, these trials could be on very small groups of patients in hospitals and clinics worldwide or larger clinical studies run by companies such as

Regardless of size, medicines need to be proven safe and effective to reach market; obviously, this requires human clinical trials.

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Why companies run trials in India

For the most part, costs are the largest factor drawing pharmaceutical companies to India. A comparably-run study in India will cost about half as much as it would cost if run in the UK or the US.

There are obviously many entirely reputable and legitimate clinical trials taking place all over the world run by organisations such as Richmond Pharmacology; however, a certain breed of unscrupulous country will be drawn to the developing world for more nefarious reasons. For these, India presents opportunities to test drugs that would not be approved in the US or UK and even to procure ‘ghost’ approval recommendations from physicians in instances when legitimate doctors would not give recommendations.

As with any industry, the vast majority of pharmaceutical operators are legitimate and not looking to cause undue harm. With some massive fines issued to companies running unsafe trials combined with a government crackdown, countries such as India may still deliver a cost benefit for some trials – and hopefully with less risk to the participants.

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