Indian Clinical trial market is estimated to grow to $ 2 billion and the numbers of hospitals that are engaged in global and local clinical trials are expected to grow to 14,000 by 2010
Drug under development for a disease undergoes extensive studies in animals and humans to establish its safety and efficacy at a particular dose, prior to being marketed. Clinical trials represent a bridge from early stage drug development to commercialization. This bridge cannot be bypassed and is long and expensive to cross.
In today’s global scientific era, clinical trials are the foundation for bringing newer and better drugs to market. There are guidelines and regulations to govern the conduct of clinical trials in any country. The conduct of clinical research is also looked upon as an area of humanitarian concern.
It takes approximately US$350 – $500 million to bring a drug from the lab to the market. This usually occurs over a widely varying time-span – 9 years on average. Pharmaceutical companies allot a certain percentage of their revenue to be re-invested in drug development. Most companies would be happy to be able to reduce this to around six to seven years, to maximize the commercial benefits of parent protection.
Drug development costs arise from clinical research, especially from large-scale multi-centric Phase 3 programmers. The most expensive failures are the ones which occur in late development. Hence pharmaceutical companies endeavor to determine the risk of failure associated with a particular drug as early in development as possible.
Clinical trials in developing countries are exploding. It is estimated that 20-30% of global clinical trial activities are being conducted in developing countries.
- Indian clinical trials market in 2006 was US$ 1.40 billion and is growing at a CAGR of 40% for the last 3 years. The Indian clinical market is estimated $1.5-2 billion by 2010. The growth of Clinical Trial Outsourcing industry is estimated to scale up to US$ 600m by 2010. Clinical trial market represents 65 percent and new drug discovery makes up for 35 percent of the Indian market.
- India dwarfs its nearest rival Italy ($ 70 million) and Spain ($33 million) and India’s Chemical Pharmaceutical Generic Association has projected that the contract research in India will grow annually at the rate of 20 percent to 25 percent.
- Clinical trials in India cost approximately $20 million while the cost abroad would range between $300 million and $ 350 million.
- Drug companies and clinical research organizations (CROs) are keen on India to cut the cost of drug development which is 60 per cent lower than US and Europe.
- More than 80 hospitals in government and private sectors are actively engaged in global and local clinical trials. According to experts it is estimated that 14,000 hospitals in the country could enter into patient studies for CROs by 2010.
- In India, the government has been allowing only phase II and phase III trials of new molecules. The phase I trials are allowed in India only if phase I trials are already done in a different country and submitted the data here.
- Some of the important trials include AIDS vaccine, Kalaazzar (Visceral Leishmaniasis) organized by the Institute of World Health in California which is conducted at hospitals in Bihar and Madhya Pradesh. The Jawaharlal Nehru Medical College at Belgaum in Karnataka is conducting a safe abortion method trial. Breast and cervical cancer trials are on at Kidwai Memorial Institute of Oncology in Bangalore and Tata Memorial Hospital in Mumbai.
- According to Dr Ashwin Naik, head Vaatsalya Healthcare, companies are getting region specific in their offering for clinical research. CROs in Ahmedabad mainly offer phase II and phase III services, Hyderabad offers full service trials, Mumbai is a base for multinational companies only for operational benefits and Bangalore is known for its expertise in clinical data management.
- A stringent regulatory system governing clinical research is not in place in India yet. Thus, MNCs like Pfizer, GSK, Novartis and Novo Nordisk are already conducting human trials on a big scale.
- Illegal trials are being conducted in various parts of the country by a large number of CROs on illiterate youngsters from slum areas. Many of these volunteers are either dying or seriously falling sick after a few months of trial. There is no system of tracking down these illegal operators and stopping them as they are operating with the support of certain unscrupulous medical practitioners. The Union health ministry is very slow in enacting laws for clinical trials in the country.