Monday, February 27, 2017

Novartis seeks regulatory consistency in India

Swiss multinational drug giant Novartis, which was among a few firms that suffered setbacks in the Indian market pertaining to patents protection and clinical trials, wants India to ensure consistency in the regulatory environment to retain and attract global investors.

Referring to episodes like overnight changes in key regulations governing clinical trials a few years back that destabilised investments of MNC pharma firms, Novartis global drug development head Vas Narasimhan said such inconsistencies send out wrong signals to investors. 

Narasimhan, who was in India to participate in Bio Asia 2017 conclave at Hyderabad, said sudden regulatory shifts will affect MNC drug companies, who make long-term investments in innovation. 

"We (multinationals) cannot simply keep adjusting. That sends a signal that maybe, we shouldn't invest as much," he told ET. 

Admitting that things have improved in consistency with rest of the world and the regulatory environment has got better now from both intellectual property and clinical trials' perspective, he said, such environment enables MNCs "invest with certainty over longer periods of time." 

However, he said "the key is it stays this way and keeps improving. Then, I think you will have more (clinical) trials coming in". 

Novartis currently conducts more than 50 clinical trials in India across all its therapeutic segments. 

Apart from ensuring consistency in regulatory policy environment, India should also allay the apprehensions of global investors at the earliest "so that it gives confidence to the principles all over the world because these clinical trials have been planned for long-term investments and they will have implications on global (drug) filings," Novartis India president Jawed Zia said.

Friday, February 24, 2017

Clinical Trials Review of Chronic Pain-API Insights, 2017

Orbis Research Present's Chronic Pain-API Insights, 2017 And has been prepared based on an in-depth market analysis with inputs from industry experts.

The active pharmaceutical ingredients worldwide market is in continuous development from the recent years. There is expected to be a major impact on the global API industry, with the large number of blockbuster drugs going off patent in the coming years. It is going to affect the revenue of the API market as generic drugs occupy the market.

Get a PDF Sample of Chronic Pain Market Report

India and China produce a large percentage of a majority of the APIs and intermediates produced in the world currently. The USFDA and EMA have strict guidelines for API manufacturing 'Process Validation: General Principles and Practices'. While countries such as Japan and Singapore are signatories to the ICH Q7 regulation, India and China follow their national GMP guidelines. The efficiency and expertise of Asian contract manufacturers have positioned them in a very strategic space in the global pharmaceutical supply chain, with a vast majority of the APIs and intermediates being sourced from markets such as India and China.

Chronic Pain -API Insights, 2017 Report describes the current therapeutics that are propelling the pharmaceutical markets worldwide. The report gives the clear idea on the United States Drug Master File (USDMF) and Europe DMF filed by worldwide countries related to the Chronic Pain. It also provides the India and China API Manufactures who are driving the current API Market. The report also highlights the patent and patent exclusivity information. The research analysis also presents the global sales data till 2016.

 


Monday, February 20, 2017

Global Clinical Trial Management System Market: Asia to Witness Highest Growth

Global Clinical Trial Management System Market Will Reach $1,848.5 Million in 2019: Asia to Witness Highest Growth

ResearchMoz added Latest Research Report titled " Global Market Study on Clinical Trial Management System: Asia to Witness Highest Growth by 2019 " to it's Large Report database.

Clinical Trial is a medical research study performed on humans to check the safety and efficacy of drugs, devices and therapeutic products before they are finally launched in the market. Proper management of clinical trials has become a priority for hospitals, pharmaceutical companies and clinical research organizations (CRO).Clinical trial management system (CTMS) is a software solution for proper management, storage and analysis of drugs associated clinical data. CTMS is primarily employed to manage the large amount of data involved in a clinical trial including planning, preparation and reporting. CTMS also provides data to a business intelligence system. It provides a user-friendly infrastructure that enables clinicians to manage trials of varying complexity.

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