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 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.

Conclusion

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.

Today antiretroviral treatment can control the virus and help prevent its transmission so that patients and those at risk can lead qualitatively better lives.

“It is only fitting that on World AIDS Day we pay tribute to all those patients whose participation in clinical trials for HIV has led to the discovery of better and more effective treatment for HIV,” said Suneela Thatte, President of ISCR (Indian Society for Clinical Research). “The clinical research fraternity owes a lot to these patients. We now need to focus our efforts on making treatment more accessible to patients and on research to further improve the potency and efficacy of existing ART medications and improve patient outcomes.” WHO says that in 2005, only 2 million people were on ART. By the end of 2015, 17 million people were on ART globally, an increase of over 800% in a decade

India has the third-highest number of people living with HIV in the world. In 2015, there were 2.1 million people living with HIV and 68,000 AIDS related deaths in India. “Hopefully the day is not too far away when we will have a cure for HIV,” said Suneela Thatte.

Content Credit: EconomicTimes.Indiatimes.com

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Well-characterised sites have a high burden of the disease as well as healthcare facilities and experts who could diagnose, treat and monitor patients over time, according to Sun Pharma senior advisor for global health Altaf Lal. He is also a chair of this joint working group. The group is considering a hub-and-spoke model of clinical trial and research sites as well as specialised laboratories, said Lal. A central unit linked to ICMR will manage these sites, distributed across the country based on the burden of the disease being studied, he said.

While details of the structure are yet to be chalked out, the group has so far considered prioritising infectious diseases like dengue and TB, Lal said. The sites could require anywhere between Rs 6 crore and Rs 40 crore in funding, according to him. At the same time, the actual funding requirement may vary as the process is still in a nascent stage, he added.

ICMR and Sun Pharma’s joint working group is expected to put together a policy paper by the time it meets again in March 2017 and will seek inputs on it from academicians and the industry, Lal said. The group intends to reach out to other pharmaceutical companies involved in innovation in India, he added. India currently lacks adequate well-characterised sites, which are vital to understand the nature of the pathogen and ailment as well as the clinical manifestation of the illness, according to Lal. It provides a baseline for trials of new drugs and vaccines targeting these ailments, he added.

“We don’t have enough data in India so it becomes difficult to design programs where data (is lacking),” Lal told ET. For instance, out of 26 new drugs approved in India in 2015, over half had no information related to women because the data was lacking, he said. According to ICMR director general Soumya Swaminathan, India needs more information and data on the burden of various prominent diseases, emerging infections and micronutrient deficiency. It also needs long term studies that follow up on patients to understand the risk factor of the disease.

Content Credit: EconomicTimes.Indiatimes.com

Original Article: Click Here