Global clinical research is exploring India. Yet, it is certainly not the western countries that is introducing clinical research to India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and Sushruta Samhita (a textbook of surgery), compiled as early as 200 BC & 200 AD respectively, show India’s age-old proficiency in medical research.
Today, clinical trials are conducted through a regulated approach following certain guidelines laid down by the International Conference on Harmonization (ICH), which is supearheaded by U.S.A., Europe and Japan.
The clinical research industry in India has been growing rapidly. During the last 3 years it has increased from INR 20 crores to INR 100 crores. According to a recent McKinsey report, by the year 2010 the industry is expected to grow up to Rs. 5,000 crores.
What makes India so special?
India has become the preferred destination for global clinical trials today. The unique criteria that make India so attractive (2-4) are:
- India has a huge population base of more than 1 billion (Indians represent about 15% of the global population)
- This population is genetically, culturally and socio-economically diverse
- Asians have been seen to react differently to drugs as compared to their Caucasian counterparts
- India has the largest pool of patients (e.g. the highest number of cancer and diabetes patients are found in India)
- It is home to a wide variety of diseases ranging from tropical infections to degenerative diseases
- The patient population in India is mostly treatment naïve
- Patient: doctor ratio is high
- There is no dearth of professionals trained in the field of medicine
- India has a large pool of highly qualified and dedicated scientists and clinical research professionals
- The country is renowned for it’s prowess in information technology
- English is a primary language of education and communication among Indians
What is Clinical Research?
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug.
Clinical Research is Conducted in 4 Phases
Phase I trials
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.
Phase II trials
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.
Phase III trials
In this phase, the group is between 1000 and 3000, for the company to use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence.
Phase IV trials
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.