Pharma regulator fails again

The death of a participant in a clinical trial by a Hyderabad-based contract research firm has refocused attention on the practices followed by an industry which is said to have great promise, because it can earn good dollars by leveraging cheap Indian skills.

A young man administered the generic equivalent of a blood pressure drug recently out of patent, being developed by an Indian pharmaceutical company, came back after a few days, complaining of chest discomfiture. The research firm shifted him to a hospital where he was later declared dead.

The drug controller-general is conducting an enquiry. As the original molecule is a tried and tested one, interest will focus on answers to questions like these: Were the volunteers for the trial properly screened (the unfortunate person was only 25)?

Did the research firm have proper medical facilities in-house to take care of someone suddenly taken seriously ill? And importantly, was the volunteer participating in another trial for another drug simultaneously without letting on? In some cities, CROs maintain a common register to prevent the last of these.

Deaths during clinical trials take place in developed countries too. Last year, for example, a woman suffering from rheumatoid arthritis died in the US while participating in research for experimental gene therapy.

The US authorities suspended the trial and initiated an investigation. It was clearly a case of someone with a crippling illness trying out something new, hoping it may work.

The same can be said of the 49 children dying at AIIMS over a period. They were all very ill to begin with. But why should a young man be felled by a single dose of a generic blood pressure drug several days after it was administered, if that was at all the reason for his death?

In India, poor people often enlist for trials to earn some money; hence the need to properly screen them in the first place to make sure they qualify to volunteer. Indian CROs make for a $200 million industry which is growing at 30 per cent a year and it will be a loss for all concerned if poor people are seen as being used in trials without understanding the risks that they subject themselves to.

This brings up the quality of Indian regulation, which is the most unfortunate part of the whole matter. Not only is supervision of Indian CROs by the health ministry virtually non-existent, it has remained so for years despite earlier mishaps.

Four years ago, WHO disqualified generic retroviral AIDS treatment drugs manufactured by prominent Indian firms because it was not happy with the way Indian CROs had conducted the clinical trials to establish the bio-equivalence (as good as the original) of those drugs.

Today, the drug controller-general is still talking about getting the CROs to register themselves with the Indian Council of Medical Research, after which they will be supervised. It is a mystery why this cannot have been done years ago.

The regulator has issued guidelines for good clinical practices and CROs have appointed ethics committees to oversee the protocols followed. But there is no inspection and audit of procedures and documentation. This is unpardonable, and underlines the nature of supervision of the entire pharmaceutical industry in India.