A gradual shift is taking place in the Asian clinical trials landscape. India is becoming the major beneficiary of the offshoring strategies of an increasing number of pharmaceutical and biotech companies deciding to move their clinical trials, which can account for two-thirds of the cost of developing a new drug.
Does it mean that India is leaving behind China, widely touted as the ?other? destination in Asia? After all, China is fiercely contesting with India to grab a leading position in the fast-growing $45 billion clinical trials and data management market. The short answer is yes and the numbers speak for themselves.
At first glance, it is a neck-to-neck battle when it comes to the total number of trials conducted in the two countries last year. China conducted 496 trials and India was just one short with 495 trials. Significantly, the share of multinationals conducting their trials in India is far greater compared to China. Majority of the top 10 pharmaceutical companies such as Astra Zeneca, Eli Lilly, GSK, Merck, Novartis and Pfizer conduct higher number of trials in India than China. Encompassing India, China, Japan, Taiwan, Korea, Singapore and Philippines, Asia conducts about 40% of the global trials.
?Since the mindset of big pharma is to move East, a conducive atmosphere by having favourable government policies and regulations, along with tech manpower will bring significant business,? says Venkat Jasti, CEO, Suven Life Sciences Ltd. With 98 trials, China clearly lags India which had a total number of 139 trials in its basket last year. Phase III trials constitute about 60% of the total trials in India compared to only 45% in China. India has the highest number of diabetic patients in the world and has a very large number of patients with cardiac disorders and cancer. Thus, not only does India lead China in cardiology, diabetes and oncology trials, it will be a sought after destination for clinical trials in these three ?hot? therapeutic areas in years to come.
Nonetheless, far from being belligerent on its new-found success, industry is advocating a cautious approach and talking of a multi-pronged strategy to keep the momentum going. Its prescription: strengthen the regulatory mechanism by making it fast and efficient, permit phase I trials and raise a substantial manpower to undertake clinical trials.
Last year?s Novartis case, in which the company lost the patent case over its cancer drug Gleevec, is foremost in its mind and such drug legal battles need to be avoided at all cost. ?Such incidents do create a bit of a concern among clients, especially in cases where there is a lot of media hype and propaganda involved. While the position of the government on patents is well known and it is supportive of IP rights, we will have more such debates and patent challenges in the years to come especially in grey areas under the law,? says Anand Bidarkar, vice-president (business development), SIRO Clinpharm Pvt Ltd. Industry is quick to point out the instance set by China when it went out of its way to protect the IP of Pfizer?s Viagra in order to woo drug companies.
Indian clinical research organisations (CROs) need to move up the value chain and start offering integrated services from trials to clinical supplies and to data management, thereby making trials more efficient. ?We are in a dynamic situation and success, if calculated in terms of volumes and value, has no meaning. Ultimate success will be determined by not ?how many? and ?how much? but by ?how fast? and ?how meaningful,? says Vasi Reddy, chairman, Vimta Laboratories.
There is no doubt that the cost of doing clinical trials in the US and Europe is absolutely prohibitive and pharmaceutical and biotech companies can save millions of dollars by shifting some of those trials to India. Brijesh Regal, CEO, Apothecaries Clinical Research says, the cost per patient for trials in India is approximately 40 to 60% of the cost in western nations.
Based on these advantages, the number of clinical trials in India is expected to grow exponentially over the next five to ten years. ?Globally, the market for clinical trials and data management is estimated at around $45 billion and there is potential to outsource 50-60% of it to destinations like India. At present, the Indian market is estimated to be around $1 billion. There is thus immense potential for growth and India could easily conduct 15% of global trials by 2011,? says Shiv Raman Dugal, chairman, Institute of Clinical Research (India).
Certainly, as countries like India and China become big markets for drug sales, pharmaceutical and biotech companies are considering tapping into them for clinical trials. China is attractive to them?with some estimates suggesting that the country could overtake the United States as the world?s largest market by 2020. To encourage more foreign companies to conduct trials in China, the government has passed new regulations and is establishing clinical practice centres to train investigators and staff.
Still, China has its drawbacks. Bureaucracy and strict government regulations pose ongoing risks for companies. For example, gaining approval from the Chinese State Food and Drug Administration (SFDA) to conduct a trial can take 9 to 12 months, and companies must acquire a drug import license for every shipment that enters the country, rather than one for each type of drug.
On the downside, IP protection in India has been weak and the country does not permit foreign companies to conduct phase I clinical trials. There are some bureaucratic headaches as well. It is mandatory for pharmaceutical companies to coordinate their efforts with local physicians and local hospitals and to perform toxicology tests between phases II and III, which can cause delays.
The silver lining is that the regulatory mechanism relating to clinical trials is being further strengthened and this in turn will boost the number of trials being conducted here. The setting of institutional review boards or ethics committees are all steps in this direction, says Utkarsh Palnitkar, head of life sciences practice, Ernst & Young India.
Then, the introduction of clinical trials registry by the Indian Council of Medical Research (ICMR) will help in creating a database for future use for meta-analysis of studies conducted in a therapeutic area of concern. It will also help in developing national guidelines for managing health care based on evidence-based medicine, says Reddy of Vimta Labs. ?Whichever country does that will attract sponsors as it will lead to competition in excellence, rather than in volumes and value. Operational timelines should be transparent in the regulatory decision making bodies as this can move us faster, as time is the essence for cost control,? he adds.
An important issue pertains to the acute shortage of manpower. McKinsey projects that within five years, 1,500 to 2,000 GCP studies will be conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals. At the moment, India is short by 30,000 to 50,000 research personnel, including trial investigators, auditors, and personnel to serve on ethics committees and data safety management boards. However, India has substantial capacity to meet the rapidly growing demand for clinical trials. It has 300 universities, over 750 graduate and post-graduate programmes, and about 50 million college graduates.
The issue of illegal clinical trials is another area of concern. According to Bidarkar, many of the incidents reported indicate ignorance rather than deliberate malafide intentions. The overwhelming majority of trials are conducted in a legal framework. Wider dissemination of guidelines and education of stakeholders will go a long way in preventing these incidents, he adds.
Finally, as India makes an earnest attempt to shed its image of the ?land of the generics,? conducting clinical trials efficiently and quickly by conforming to the global best practices could be its ticket to success.