In this issue

India to bounce back as Clinical Research Hub

India was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.

Amgen Collaborates With Humana To Improve Health Outcomes

US Biotechnology company, Amgen and leading health organization, Humana have teamed up to identify opportunities to improve health outcomes and improve efficiency by unlocking new insights from the real world health care experiences of Humana's 13 million members.

1 min

“We Have Streamlined The Whole Process Of Reviewing And Approval”

Indian Council of Medical Research (ICMR) signed an agreement recently with other global agencies to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly available registry. 

3 mins

India To Bounce Back As Clinical Research Hub

India was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.

8 mins

Pharma Exporters To US Under Pressure

Recent USFDA hike of fee for processing ANDA will certainly going to put immense pressure on the Indian pharma industry, resulting eviction of many small players from this pharma export business.

5 mins

Aims At Providing A Longer Term Stable Policy Environment

To overcome the challenges like Declining CAGR; Non-adherence to quality standards and norms; Growing competition from other countries; Dependence on imports for the key starting materials as also of the APIs; Lack of R&D and discovery of new molecules, and to improve the situation of the pharma industry, India has come up with draft pharma policy 2017.

5 mins

The Generic Drug Push Needs Further Clarity

The policy encourages indigenous production of APIs and Key Starting Materials (KSMs) in several ways. However, a more thorough approach is required to once again enable the domestic API industry to become competitive. The Indian government needs to focus on developing the local chemical industry which can then in turn support API manufacturing.

4 mins

Biotechnology - Where Is It Heading?

On one hand, the biotechnology industry is starved of skilled talent pool. On the other hand, there are several universities and colleges, producing number of unemployable graduates. While some of them are struggling due to lack of students. So serious thinking needs to be done urgently to overcome this problem.

2 mins

“Data Sharing, Post Study Access To Trial Medication Are Emerging Frontiers”

“Data Sharing and Post study access to trial medication for study subjects are the two emerging frontiers in clinical research space,” said Dr Saral Thangam, CEO & Managing Director, Norwich Clinical Services.

2 mins

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Bio Spectrum Magazine Description:

India's leading publication that covers the business of bio-technology. With comprehensive analyses of policy issues, products and services across the bio-pharma, bio-informatics, bio-infrastructure and bio-agriculture segments, it is the industry's most authoritative source of information.