Trial(s) by Fire

Circa 2010: As per a study published in the Indian Journal of Medical Ethics, the number of trials conducted in India grew at a whopping rate of 36 per cent annually from 2006-07 to 2010-11. Even these figures, it claimed were an under representation since registration as a part of the clinical trial registry was made mandatory only in 2009. Availability of a diverse gene pool, cost effectiveness (conducting trials in India is upto 50 per cent cheaper than in tightly regulated markets such as the US and Canada) and a faster patient recruitment fuelled the country’s rise on the world map. Data reveals that as much as 250 new trials were conducted by MNCs every year from 2007 -2010.

Riding on the trend above, there were predictions that the industry would continue its upward swing and gain a market share of 15 per cent by 2011. However, the same year saw the number of trials steeply decline as opposed to the early years. Lack of certified trial sites was further accentuated by DCGI’s stringent guidelines on clinical trial inspection programme in late 2010. This along with recession, concerns on data protection, skill sets, infrastructure and delay in approvals were some of the reasons analysts gave for the slowdown. The situation worsened further after a PIL was filed in the Supreme Court in January this year on alleged illegal trials on untested drugs that further exacerbated the issue putting companies in the line of fire. The Drugs Controller General of India (DCGI) and health ministry have sprung into action putting forth guidelines making it mandatory to register clinical trials and form ethics committees to monitor the same.

Pause for a cause?

The current market for clinical trials is estimated to be between $200 million to $600 million as against $1 billion dollar projection by Frost and Sullivan in a report last year. However, Utkarsh Palnitkar, Partner, National Head, Life Sciences Practice, Head- Transactions and Restructuring, KPMG India pegs it to $620 million in 2012. It is difficult to project a CAGR, although it should be significantly lower than that forecasted some years ago, he adds. The numbers translate to a share of two per cent or even less in the global pie.

Defending India’s position, Dr Sauren Das from Excel Life Sciences, a Clinical Trial Management Organisation based in the US says, “India only joined the WTO in 2005 and subsequently started conducting more global clinical trials. Any significant drop off has really only occurred during the last six to eight months – during which time there was a lull in the review of new applications, while the agency revamped regulatory process.” China, on the other hand has cornered over nine per cent share of the global clinical trials market.

“In such a scenario, de-risking by conducting trials in countries with a more robust regulatory framework is a better strategy. Karmic Life Sciences has just completed its first study in South Africa.” Dr Deven Parmar Chief Scientific Officer, Karmic Life Sciences

Even as the noose on erring companies is tightened and regulations get tougher, the brunt is borne by everyone. Indefinite timelines and delays in approval can cost much to a company on the brink of discovering novel compounds. “Once you have filed an application with the drug regulator, you have no idea how long it may take to get approval for trials here. In early trials, time is money since many other companies across the globe are doing similar drug research,” adds Dr Deven Parmar, Medical Director, Americas, Karmic Life Sciences. He cites a lack of technical competence, improper confidential data management, misplacing of files and absence of a delegation system when an officer in charge goes on a leave, further leading to inordinate delays.

The industry also strongly feels that while adhering to ethics and compliance issues is understandable, the current scenario puts all and sundry under the scanner, putting processes to a halt for even those going by the book.

“A spate of negative media coverage has projected clinical research in a poor light and NGOs petitioning the courts have made matters worse resulting in a moratorium on clinical trials with the government having decided to penalise everybody for the non-compliance of a few.” Dr Anand Eswaraiah MD, Head, Clinical Development & Regulatory Affairs, Clinigene

“A spate of negative media coverage has projected clinical research in a poor light and NGOs petitioning the courts have made matters worse resulting in a moratorium on clinical trials with the government having decided to penalise everybody for the non-compliance of a few. Only six studies have been cleared in 2013 by the DCGI,” Dr Anand Eswaraiah, MD, Head, Clinical Development & Regulatory Affairs, Clinigene, makes a point. And, there are a number of applications still pending. Clarity on insurance cover and compensation norms has also hampered growth.

Even though the US continues to be the largest market for clinical trial services and along with Western Europe dominated the market, accounting for more than three quarters of global revenues in 2011, emerging countries will continue to hold interest and its not hard to understand why. The market share for the BRIC nations (Brazil, Russia, India and China) will triple during the period 2011-2023, reveals a report by ASD Reports. But until then, companies are trying to figure a way out of the chaos and gather some momentum.

This too shall pass

“In such a scenario, de-risking by conducting trials in countries with a more robust regulatory framework is a better strategy. Karmic Life Sciences has just completed its first study in South Africa,” informs Dr Parmar. While South East Asian countries like Malaysia, Singapore are well known clinical trial hubs, companies are exploring conducting trials in places like South Africa, Eastern Europe etc, he adds. These destinations might be in addition to and also at times as an alternative to India, chips in Palnitkar. Some of the bigger CRO’s have increased their footprint in countries such as Philippines, Malaysia, South Korea, and are also considering Vietnam, Cambodia etc, he opines.

Industry is hopeful that even as their business has been hit hard, regulators certainly seem to have taken on board the pertinent issues and are working on setting them right. Says Das in retrospect, “With a robust and growing industry, there are bound to be issues and rogue players. The industry’s problems were magnified due to the rapid expansion of studies during a relatively short time period. A slower start followed by regulated acceleration could possibly have been better.” He thinks that amendments are in order, as reflected by some of the recent regulatory changes, that will help us bounce back again.

He argues that most companies are doing good ethical research and in compliance with ICH-GCP guidelines. A look at the FDA inspection data reveals that Indian sites are passing muster with one of the world’s most stringent regulatory agencies. Over a seven-year period between 2005 and 2011 and more than 30 site inspections, they have not received a single, OAI – Official Action Initiated, the most significant and negative of findings the agency can levy following an inspection. A site-centric operating model as followed by ELS focused on support of the investigator on a 1:1 basis could also be where the answer lies considering that less 15 per cent research sites in India have a full time clinical research coordinator (CRC) and even those are spread out across multiple trials. “We believe that India is still in its infancy in terms of the conduct of global clinical trials. Such support is critical to ensuring high quality of work that benefits both the patient and the sponsor respectively,” he adds.

Looking ahead, as the global market continues to grow at a high single digit CAGR and is projected to be worth $30 billion in 2015 largely driven by the demand for late phase trial services, India surely has a part to play as soon as it gets its act together. “Instead of blindly putting clinical trial approvals on hold, the government needs to efficiently monitor ongoing trials for regulatory compliance and penalise non-compliant companies. We believe we need to address the issue of clinical trials not with blind emotion but with a rational understanding of the benefits and with greater compassion for those suffering for want of effective medicine,” sums up Eswaraiah.

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