The year 2016 has been quite an exciting one for the Indian pharmaceutical industry. The market clocked an impressive compounded annual growth rate of 17.46% over the period 2005-2016. By 2020, the Indian pharmaceutical market is expected to be among the global top three by incremental growth and is expected to be the sixth largest market in the world in terms of absolute size.
India is expected to be among the top 25 nations in the Global Innovation Index within the next 10 years.
After the slowing down experienced in 2013, the clinical trials industry in India is seeing an upward trend. There are several reasons behind the positive growth in clinical phase 1 and phase 2 trials in India, the least being the proactive approach and business-friendly ‘Make in India’ initiative of the Indian government. 107 clinical trial NOC approvals were granted in 2013 and this number jumped to 150 in 2014. The rebound continued into 2015 as well.
Here are a few reasons why you can expect to see robust growth in the Indian clinical research sector come 2017.
1. Simplification of Regulatory Procedures
Ambiguity and uncertainty regarding regulatory procedures had lead to a slowdown in the number of clinical trials approved in the country. But new updates have made the approval process quicker, predictable and in line with global practices.
Revised clinical trials’ guidelines allow compensation to be paid only up to the point that the drug resulted in an adverse reaction in a patient participating in the trial. This is a significant change from the earlier rule which stated that compensation has to be paid irrespective of whether the drug caused the serious adverse event or not.
Regulatory procedures have also made it clear that audio visual recording of informed consent is not mandatory in all cases.
The Central Drugs Standard Control Organization (CDSCO) set up online licensing portal SUGAM in March 2016 for import and registration of drugs and medical devices. The online services have been extended to pharma companies to submit and apply for clinical trials as well.
2. Latest Proactive Steps Taken by the Government
In order to bring India back on the global clinical research map, the Drug Controller General of India is also mulling on providing online NOC (no objection certificate) to pharma companies to conduct clinical trials in India.
If this comes through, relevant documents can be submitted online reducing the time and effort required to submit hard copy at the office. The applicant need not be physically present at the office at any point in time and can monitor the status of the application on the portal.
The government aims to speed up approvals, remove middlemen and bring about transparency with these new guidelines. Simple and hassle-free application processes will help streamline the clinical trial industry and attract global companies to India.
The Indian Council of Medical Research (ICMR) financed only 26 clinical research projects in 2015-2016 as compared to 71 projects in 2014-2015 and 120 in 2013-2014. Health Minister J.P. Nadda has promised ICMR full support and financial backing to support and fund clinical research projects in institutions in India. Last month Sun Pharma joined hands with ICMR to develop well-characterised sites and conduct clinical research with a special focus on diseases prevalent in India.
3. Encouragement to Local Stakeholders in Clinical Research
The new circular released by CDSCO removed the restriction that did not allow investigators to conduct more than 3 clinical trials at any given period in time. The DCGI has put the onus on the Ethics Committee to take into consideration the complexity and nature of clinical trials and grant permission for trials accordingly. This is a major boost to experienced investigators and key opinion leaders (KOL) to leverage their expertise and drive industry growth in India.
Indian government has also revised the mandatory requirement that clinical trials can only be carried out at sites that have more than 50 hospital beds. The Ethics Committee can use discretion to decide whether the clinical trial site is suitable for the trial or not. It is mandatory that the site has emergency medical care and rescue arrangements required for the clinical trial.
4. Global Incentives to Grow
The US is the biggest drug market in the world with an estimated market value of around US$ 413 billion in 2015. The Food and Drug Administration (FDA) regulates the US drug market and Indian pharma companies and CROs also comply with FDA norms and regulations. With the election of Donald Trump as the new US President-elect, the policies of the new government will also have an impact on Indian pharma and clinical research industry.
The President-elect has voiced his support for safe, effective and cheaper drug imports and this could be a big boost to Indian pharma companies that supply about 40% of the total generic drugs consumed in the US. Trump has also generally promised to increase funding to research agencies including National Institute of Health, which too could augur well for the industry.
Indian clinical research industry has very strong fundamentals including a genetically diverse patient pool, a vast population in need of medical treatment, qualified medical professionals, clinicians and data specialists, and good regulatory policies. Though the industry has taken some time to regroup after introduction of new regulatory practices, it is all set for growth now.