Do you want to know why India a favourite hub for clinical trials? Well clinical research is one of the areas of the drug discovery process that is carried out to make sure that the novel drug is efficient and safe. Clinical Research has a huge set of standards and guidelines, yet there are some reports of unethically conducted trials that gave rise to humanitarian concerns. This also resulted in a reduction in the number of clinical trials that are conducted in recent times. In this matter, Indian government took initiatives to standardize the regulatory guidelines and enforce rules to maintain a well balance between business and ethical issues.
There are many regulatory bodies to look after pharma regulations in India like the Drug Control General India (DCGI), Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT), Central Drugs Laboratory (CDL),Drugs Technical Advisory Board (DTAB) etc to name only a few.
Availability of study volunteers, highly skilled healthcare professionals, cost effectiveness and timeliness are the prerequisites of a successful clinical trial. To mention a huge patient pool is one of the main reasons that place India up as one of the most favourable destinations for clinical research. India comprises about 18% of total world population with 1/5th of the global problem of disease. It records highest rate on maternal, neonatal and child deaths in the world. Also, there is an increasing occurrence of communicable like TB, malaria, HIV etc and non-communicable diseases like cancer, heart diseases, diabetes etc putting heavy cost burden on the healthcare expenditure.
India has a diverse talent pool with a large number of healthcare professionals like physicians, nurses, lab technicians, scientists and clinical practitioners. Further, a large number of skilled professionals in the field of IT and other sciences which are related to clinical trials; and this made India an obvious place of choice for clinical trials.
Another important aspect that draws the attention of clinical trials industry towards India is cost competitiveness. The cost for carrying out clinical trials in India is 1/10th of that in the USA. With many pharma companies relocating or outsourcing the clinical trial processes to India, the R&D expenditure in pharma industry has witnessed a great rise. The set timelines by the regulatory bodies in India makes sure that the trial applications to be approved in a comparatively shorter duration of time. For instance, DCGI gives its first approval for carrying out clinical trials within 45 days whereas for conducting a bioequivalence study it takes 28 working days. Approval of investigational new drug (IND) by any referral bodies or an expert takes an additional 12 to 14 weeks. Any issues in the applications they are sent back for a review and hence the process delays by another 45 days.
And a debatable topic is whether it is exploitation of the poor population of India by pharma companies to conduct clinical trials. But, most of the trials in India involve testing of drugs in clinical trial phase III, or already tested drugs; thus lowering the risk and also provides an access to new therapies. Moreover, there is an increased emphasis on following proper regulatory norms in order to stop unethical practices of recruiting subjects for carrying out clinical trials and protect the vulnerable population against any kind of exploitation.
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