New and stringent guidelines have come as both good and bad news for the industry, which doubts their practicability, but welcomes the more secure environment they will guarantee

When in 2002, McKinsey predicted that the Indian clinical research industry would be worth $1 billion by 2010?based on science, on the advantages India offered for the industry and

other favourable factors?there was a rush of investments in the country, several new clinical research organisations (CROs) mushroomed and a large number of trials got underway.

But the industry managed to reach just $250 million by 2010. Controversies over negligence and corruption, compounded by litigations in the Supreme Court, and government inaction sucked the steam out of it. And yet, a Frost and Sullivan report last year pegged the industry size at $485 million and forecast it to grow to $1 billion by 2016, even when the number of trials conducted in the country had fallen from a high of 500 in 2010 to half that number last year.

Boosting the mood further is the bitter-sweet pill of new guidelines by the Central Drugs Standard Control Organization (CDSCO) in February this year for the conduct of clinical research in India, as a result of intense discussions and debates on the need for a more robust regulatory environment.

Immediately after being reprimanded by the Supreme Court in January 2013 for ?failing to take proper note of the legal and ethical ramifications of clinical trials?,

the health ministry asked for compulsory registration of ethics committees and regular monitoring of clinical trials.

Rules relating to compensation for injury and death were also framed to include payments for immediate and long-term medical treatment of injuries sustained, compensation for disabilities and payments to heirs in case of death.

Apart from several sub-committees involved in approving clinical trial applications meeting regularly and fast-tracking approvals since January this year, the government-appointed panel chaired by Dr Ranjit Roy Choudhury will be ready with its recommendations on a new set of rules for clinical trials in the next couple of months.

The drug regulator also stated that it would periodically inspect clinical trial sites to ensure these comply with the recently issued guidelines. All zonal offices of the CDSCO were directed to form expert teams headed by a senior drug inspector.

?The expert committee, along with drug inspectors, shall visit the clinical trial sites at least once a year to verify compliance with Schedule Y, GCP (good clinical practice) guidelines and applicable regulatory requirements,? said

GN Singh, Drug Controller General of India (DCGI), in a letter issued last month.

Pharma companies, CROs and doctors are optimistic that these regulatory initiatives are a step forward and would create a secure environment for conducting clinical trials in the country, which will put India back in the game.

?After the first few weeks of 2013, the CDSCO put in place additional resources to clear the backlog of clinical trial applications and the new drugs advisory committee meetings were also being scheduled regularly,? says Suneela Thatte, president of Indian Society for Clinical Research.

?Regulators have moved ahead to create a more conducive environment for the conduct of clinical research in the country. It will take time for the dust to settle and confidence to be restored within the industry, but we are on that path,? says Anil Raghavan, managing director, Quintiles India, a leading global CRO.

However, the road to recovery is a slow one and concerns still abound. India has 16% of the world?s population and 20% of the global disease burden, and yet, less than 2% of global trials take place in the country, despite its competitive cost base and a strong scientific talent pool. China, a relatively late starter in the clinical trial area, has over 9% share of global trials.

?The current regulatory timeline for approval of a trial is around nine months. This means Indian companies would get less time for recruiting patients,? says Dr Arun Bhatt, president of CRO Clininvent Research.

The compensation clause is another issue plaguing the industry. ?The compensation rules mandate that the sponsor has to pay compensation for a serous adverse event (SAE), whether such an SAE is linked to the drug under investigation or not. This means that the cost of Indian trials would go up, making it difficult for India to become a clinical trial destination of choice,? Bhatt opines.

Pharma company Biocon feels ?a better way of compensation would be to provide patients who participated in a successful trial with free or subsidised drugs?.

?In the current form, the compensation guidelines will have a detrimental effect on the growth of clinical trials in India,? adds Thatte.

However, the industry is not daunted by the obstacles. ?The current challenges are also a good time for CROs in India to explore emerging opportunities in the area of data-driven or peri-clinical services,? says Raghavan.

To bring about a turnaround in the clinical trial industry, some pharma companies have also proposed that drugs that have already obtained approval from the US or European regulators should be exempted from clinical trials in India. ?The regulator should give such drugs a conditional approval and give them a year?s time to collect safety and efficacy data post-marketing. The final approval should be given after submission of this data,? says a Biocon spokesperson. The ball is now in the Choudhary panel?s court.

TRIAL BY NUMBERS

* The price of tracking the progress of an Indian patient in a clinical trial is about $2,000, wrote Jean-Pierre Garnier, CEO, GlaxoSmith-Kline, in Harvard Business Review (May 2008). The

corresponding cost in the US is 10 times of that amount.

* The industry estimate of the per patient cost to conduct cancer trials (the most expensive) over three-four years for India is between $8,000-$10,000, while for the US, it is between $15,000-$20,000.

* The domestic clinical research organisation market was worth $485 million in 2011 and is set to cross the $1-billion mark by the turn of 2016, according to a 2012 Frost & Sullivan report.

* There are an estimated 1,50,000 people enrolled in clinical trials in India, according to the Central Drugs Standard Control Organization (CDSCO).

* Around 60% clinical trials in India are carried out by pharma companies.

The remaining 40% are outsourced to contract research

organisations (CROs).

* The market for phase II and III clinical trials is estimated to be worth $100 million, according to the Indian Society for Clinical Research (ISCR).