India’s drug regulator looks hell-bent to put its act together amidst a surging number of reports alleging gross violations of standard protocols in conducting clinical trials in the country.
Clinical research has been making many headlines in the media recently. The wide-ranging reports converge at a single point: breach of ethics. At one extreme, health activists protest authorities’ leniency in cases of errant investigators. For example, a dozen doctors were let off with paltry fines for conducting clinical trials without the required permission from the authorities nor informed consent from the patients on thousands of unsuspecting inmates in public hospitals in Indore, a city in the central Indian state of Madhya Pradesh. On the other end of the spectrum, again from Madhya Pradesh, another set of allopaths conducted unauthorized trials using untested herbal formulations.
Casualties during clinical research continue to rise, as has the criticism against trial sponsors for non-payment of compensation for grievous injuries. Despite the fact that more than thousand deaths occurred during clinical trials since the last three to four years, only a little more than 20 families were compensated by drugmakers to date. As many as 462 people who took part in clinical trials died in the first half of 2010 alone, according to figures available with the Union Health Ministry. There were 132 deaths in year 2007, 288 deaths in the year 2008 and 637 deaths in year 2009, as per the government data.
Reports say that at least 150,000 people participated in clinical trials across the country since India agreed to Good Clinical Practice guidelines (GCP) in line with WHO norms in the beginning of 2005. However, India's existing GCP guidance does not elaborate on the aspect of compensating participants for injuries or death during clinical research.
Taking a serious look at concerns on compensation, India’s drug regulator is currently in the process of plugging the gap. The department of health has already drawn up a set of guidelines proposing to amend existing provisions of the Drugs & Cosmetics Act 1940. The draft guidelines aims to make it mandatory for the sponsors to pay compensation for all injuries related to clinical trials.
Getting into a more proactive mode, India has initiated a number of measures to streamline its fledgling CRO industry, in the past three years. From June 15th 2009, registration of all clinical trials conducted in the country were made mandatory before the enrollment of the first patient, to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial dataset items. Till then, it was voluntary for the firms to list in the Clinical Trials Registry-India (CTRI).
Again, as a measure to create transparency and accountability, the agency has asked all the CROs to register themselves. Similarly, random, on-the-spot inspections of clinical trial sites were proposed from July 2010 for checking deviations and ensuring compliance with the current GCP norms.
Valued at more than $300 million, the sector has been witnessing double-digit growth through these years, attracting a lot of attention worldwide. A low-cost base and a huge reserve of genetically diverse, treatment-naive patient population are the big incentives offered to global drugmakers to run trials in India. Over-zealous CROs without strong credentials also proliferate, leading to confusion.
Violators Far and Few?
“It’s not that ethical violations have become a rule in India rather than an exception. They happen here as anywhere else. But the difference here is such isolated incidents are blown out of proportion by the media sending out wrong signals to the world that whatever goes here is unethical,” said a senior investigator associated with a global CRO operating from Mumbai, preferring anonymity.
Most of the 200-odd CROs conducting various clinical trials in India go strictly by the rule book. Violations of standard practices and ethical norms, according to him, are done by a very small number of players and a few investigators who often have other vested interests.
CROs find patient recruitment timelines are faster in India than elsewhere. However, the regulatory approval times are quite long. It takes an average of eight to 12 months to get nod to start off the trials. This inordinate delay often nulls the benefit of a speedy trial process. Most transnational firms see the lagging approval to startup time as a major impediment to Indian operations. On the other hand, regulators assure that the timelines will improve along with all the required checks and balances to foster the upcoming sector.
And there is good reason to hope that things won’t be too late for systems to fall into place, if the zealous approach of the agency is anything to go by. India does realize that there is a big opportunity in clinical research. But it is going to be a tightrope walk for regulators. The challenge is to strike a fine balance between the industrial aspirations of a fast-emerging economy and the over-riding concerns on the safety of its population.
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at firstname.lastname@example.org.