The Indian clinical trials industry is facing a rough weather and the country’s 120 clinical trial companies are in a tight spot . The industry is undergoing a churn as small and fly-by-night operators vanish and medium as well as large quality players are fast strengthening their capabilities to face the headwinds.
The new global and Indian regulatory guidelines indicate that the country is now losing its foothold in clinical trials. It is estimated that over 75 per cent of the sector are passing through a wringer as new trial designs mandate use of electronic records and maintenance of total transparency from ethics committee registration, patient recruitment, adverse drug reactions, and reporting deaths said industry experts.
The leading names in the over 120 clinical trial organizations in India are Ecron AcuNova, Clinigene, Clin tech, Lotus Labs, Omnicare, Quintiles, Pharm Olam, ICON, Vaatsalya, Norwich, D2L Pharma, St. John’s Centre for Population Studies, Synchron Research Services Pvt Ltd, SIRO Clinpharm, D2L, SMO India, G7 Synergon Life Sciences, ANSA, Anvihta and Triesta Life Sciences.
The stance of the regulatory authorities has also added to the woes of the clinical trials industry. Following the Supreme Court order which slammed the government of India for its failure to stop illegal clinical trials of untested drugs by multinational companies, there has been a slew of regulations by the Drugs Control General of India (DCGI) from February. These are registration of the ethics committee;constitution of three independent expert committees to assess the reports of serious adverse events (SAEs) of deaths occurred during the clinical trials; setting up a panel to frame guidelines for clinical trials along with clearances for new drugs and ban of medicines; notification of new rules by the Government of India under Drugs & Cosmetics (D&C) Rules allowing the DCGI as the final authority of decision for compensation in the cases of serious adverse events like deaths and injuries during the trials.
The industry was quick to act and in April 2013, Central Drugs Standard Control Organization (CDSCO) received a bout of applications for the registration of over 200 ethics committees that came in for formal clearances.
The European Medicines Authority (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials.
The framework provided in the paper applies to medicines for humans and enforced from May 1, 2012. The USFDA too has now raised the bar for clinical trials data. In India, the DCGI has now started auditing the clinical trial organizations and has set up the Clinical Trial Registry of India (CTRI).
“There are serious concerns now for the sector. India is no longer preferred for human studies as countries like South Korea and Philippines have proved to be favourable going by the speedy regulatory clearances, said Dr Krathish Bopanna, president, Indian Society for Clinical Research (ISCR) and president & executive director, Semler Research Center Pvt Ltd.
Dearth of clear-cut guidelines and lack of clarity on the initiatives taken by the Indian regulatory authorities , is eating into the vitals of clinical trial companies. Although India has been a much- sought after hub for human and animal studies, now with the Supreme Court directive to stop illegal trials have created a wrong impression of the companies, said Dr. Bopanna soon after the SC order on the government’s failure to put in a mechanism in place for human studies.
Pharma companies who have a new drug applications (NDAs) are unable to predict when it would be cleared by the regulatory authority for a clinical trial. Even clinical trial companies have to register in the Clinical Trial Registry of India (CTRI). Undue delays will cascade into unemployment and revenue loss, leaving many clinical trial organizations with the only option of downing the shutters, he added.
The government does not realize the need for fast track approvals nor transparency. Therefore we do not see any reformation for this sector which has helped generate revenues not just for the pharma industry but also for healthcare providers as many human studies are conducted in hospitals, informed the ISCR president.
Despite the fact that drug trials are critical for pharma companies to bring in more efficacious medicines for the increasing patients in the country, the conduct of a human study has always been an emotive issue. There are many allegations that patients have succumbed during a clinical trial or consent was not sought or even volunteers were treated as guinea pigs. Though we do not deny faults, shortcoming and inefficiencies which could exist if companies are not responsible, a handful of these instances have marred the reputation of well known and accountable clinical trial companies. But collectively we are all responsible for the current deficiencies of a few companies, said Dr Bopanna.
There are surprise audits at trial sites and studies are conducted adhering to all regulatory norms. With inordinate delays on the part of the Indian regulators, the country is missing the bus. This is an age of patent expiries leading to generic drug and biosimilars growth opportunities which require country specific human studies. India is a leader in generics with its expertise in reverse engineering. But now global pharma majors are looking at the Far East for the expertise, economies of scale and efficiency of faster turnaround, said Dr. Bopanna.
Economic gloom impacts clinical trials
The global economic slowdown together with the slackness of Indian regulatory authority has led us to lose 60 per cent of the business. Only those companies engaged in bio-equivalence studies are able to survive and those focusing on clinical trials cannot succeed. While the slowdown of the economy has eroded front-end clinical trials business, the back-end jobs have survived, said Dr. Bopanna.
Even in the much known expertise of Pharmacovigilance, India may lose its position. In fact, until a few months ago, clinical research organizations and hospitals were gearing up to arm themselves with advanced software for the offering pharmacovigilance because it was seen as being the future for clinical research sector and India was being sought-after for backend services, pointed out Dr Saral Thangam, managing director, Norwich Clinical Services.
The international regulatory mechanisms issued by the US FDA (Food and Drug Administration) EMA and the DCGI for clinical trials will change the face of clinical trail management. Such guidelines need to be stringently adhered. There is no doubt that it will only bring in accountability, transparency and efficiency, said Dr. DBA Narayan, pharma consultant.
A decade ago, the clinical trial industry was projected as the next big thing in the life sciences space with the capability to replicate the outsourcing success stories in information technology and business process outsourcing.
Experts had forecast that India would grab 15 per cent of the global clinical trial share by 2011, from the less than one per cent at the time.
But sadly, the projections have gone awry. Industry experts say that the business for conducting human studies is on the downslide. Many multinational companies prefer other emerging destinations in South East Asia such as China, Korea and Singapore. These countries have proved that India’s distinct advantage with its English speaking and qualified professionals along with a large pool of medical experts are no longer an attraction. The stark reality is that South East Asian countries have now armed themselves with the required regulations, set-up modern hospitals., increased efficiency in business leading to faster turnaround, said industry veterans.
There is focus and determination not just with the government but with the industry and healthcare providers to garner the revenues coming out of this indispensable human studies that are mandated to launch new drugs, said Gurudatta GG, CEO, Estima Pharma Solutions LLP.
In 2010, the number of trials was reported to be 529. According to data sourced from the Union health ministry, the number of clinical trials approved by the CDSCO have come down by over 50 percent to 253 in 2012.
In 2010, the CDSCO had received a total of 546 applications for conducting clinical trials in the country, of which 529 were given permission. Further the number of applications received by the CDSCO for conducting clinical trials nosedived from 546 in 2010 to just 306 in 2011. After screening the 306 applications, the drug authorities gave permission to conduct 283 clinical trials in the year 2011. Though there has been a spurt in the number of applications received by the CDSCO in 2012, the number of clinical trial permissions granted by the authorities came down drastically. Out of a total application for 480 clinical trials, the CDCSO granted permission to only 253 trials in 2012.
The recession, regulatory issues, absence of laws, apprehensions of data protection, skill sets, infrastructure and delays in approvals all contributed to the decline in trials.