It takes almost 8 to 10 years for a ‘new drug candidate’ to get transformed into an authorized drug.
The pharmaceutical industry is an inevitable source of economy globally. The overall sales of the pharma industry alone accounts for almost one trillion US dollars per year.
The effect of corporate globalization has impacted the pharma world as well. The global pharmaceutical giants have constantly outsourced the production of medicines, vaccines and commercial clinical trials to developing countries.
Like any other industry, clinical research industry had wide reception in developing countries like India and China.
Need for outsourcing
In the past, human trials have been conducted only in developed countries like US and the UK, but in the past few years, the global pharma companies have shifted their attention to the developing Asian countries for their clinical research needs.
The clinical research market in developing countries has been upsurging in the past few years.
It has been reported that around a quarter of the clinical trials conducted globally are from developing countries. Most of the pharma companies outsource entire or a part of clinical and regulatory processes to the contract research organizations (CROs).
Availability of highly skilled healthcare professionals, hospitals and laboratories with state-of-the-art facilities and a mixed pool of patient population with wide genetic assortment have charmed the global pharmaceutical market towards these developing nations.
It has been reported that approximately 1.2% of the global clinical trials conducted are in India.
These outsourced clinical trials will bring benefits on a wider scale – both to the companies and patients as well.
The mixed patient population will help the companies to investigate novel drugs quickly and efficiently. On the other hand, these research investigations give the poor an opportunity to access high quality treatment by participating in the research trials.
The concept of outsourcing of clinical trials developed only a decade ago.
The regulations of the FDA (or its equivalent authority) has been straitened up with more stringent guidelines in the developed countries.
The whole process of drug approval generally takes more than a decade, thus making it hard for pharma companies to gain profit in a short time.
So, in order to accelerate the process, the pharma companies outsource clinical trials to developing countries to gain a miscellany of data from wide ethnic back grounds.
Drug discovery and research are complex undertakings. Clinical trials are indispensable for any pharmaceutical research and innovation. It takes almost 8 to 10 years for a ‘new drug candidate’ to get transformed into an authorized drug.
Thousands of efficacious compounds are screened for safety and efficacy including the three-phase clinical trial before launching into the market.
Outsourcing of clinical trials have become a common trend in the recent years. The boon and bane of this trend has yet to be unraveled.