Clinical trials guidelines and laws in India have recently been revised. The new updates make the approval process quicker, more predictable, and as per global norms. This has improved the future of global clinical trials in India.
Last year has been particularly exciting for the Indian pharmaceutical market. With a compound annual growth rate of 17.46% over 2005-2016, the India pharmaceutical market is expected to grow at an annual rate of 15% per annum between 2015 and 2020. It is expected to grow to US$ 55 billion by 2020 and become the sixth largest in the world.
After the slowdown between 2011 and 2013, the clinical trials industry in India is bouncing back. There are a few reasons now why companies may want to do clinical research in India. Earlier, there were a few uncertainty about clinical research regulations in India. This led to the slowdown of clinical trials in India.
Clinical trials regulations and laws in India have recently been revised. The new updates make the approval process quicker, more predictable, and as per global norms. In March 2016, the Central Drugs Standard Control Organization (CDSCO) set up an online licensing portal SUGAM which makes import and registration of drugs and medical devices faster. Submission and application for clinical trials in India is also managed online through this portal.
The time and effort needed to submit hardcopies of relevant documents at the office of the Drugs Controller General of India (DCGI) is greatly reduced. The government is trying its best to eliminate middlemen and encourage transparency in the submission and approval process. Now, the applicant does not have to be physically present at the DCGI office and can keep track of the application on the portal.
Local stakeholders are also being encouraged to be involved in clinical trials in India. The restriction on investigators to be involved in a maximum of three clinical trials at any given point of time has been removed. The onus is now on the Ethics Committee (EC). The EC can take into consideration the nature of the trials and decide if an experienced investigator may be allowed to take on more than three trials at any given time. Clinical research in India no longer needs to be carried out only at sites that have more than 50 hospital beds. The EC can decide whether the site is suitable for a particular clinical research study or not, provided the site has emergency medical care and rescue management services available for the clinical trial.
A genetically diverse patient pool, a large disease burden, a vast population in need of medical treatment, qualified medical professionals, clinicians and data specialists, and now good regulatory policies as per global standards make India a favorable destination for clinical research in the future.
Note: If you are looking for a company to manage your clinical research in India, the authors of this article suggest Excel Life Sciences Pvt Ltd.