Category — Healthcare

India Calls for Post-Sales Monitoring of Cancer Drugs

An “Apex Committee for Clinical Trials” has been constituted by the Union Health Ministry on the directive of the Supreme Court of India.  Outsourcing Pharma.Com reports that this committee now requires developers of cancer treatments approved without trials to monitor the first 500 patients to assess the drug’s safety and efficacy. An analysis of the data acquired will need to be submitted to the Drugs Controller General of India, who will then forward it to the Technical and Apex Committees for scrutiny.

The new recommendation comes after the marketing approval was granted to Merck’s Zolinza (vorinostat), and Medivation and Astellas’ Xtandi (enzaltuamide), both treatments for cancer. Further, the Apex and the Technical Committees have approved 28 of 31 submissions for clinical trials.

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January 11, 2015   No Comments

Technical Advisory Board for Medical Devices to Be Set Up in India

The Health Ministry  of India proposes to constitute a Medical Devices Technical Advisory Board to counsel the federal and state government on technical issues related to medical devices.

The Director General, Indian Council of Medical Research, will be the ex officio chairperson of the board, and the Drugs Controller General of India will be the ex officio member secretary.

Besides these officials, the board will have one expert each from the departments of:

  • Science and Technology
  • Atomic Energy
  • Electronics and Information Technology
  • Federal Testing Laboratories
  • Pharmaceuticals
  • The Bureau of Indian Standards
  • The Defense Research and Development Organization
  • The Indian Commission for Drugs

Other members will be inducted from the following areas:

  • Biomedical technology
  • Biomaterial or polymer technology
  • Consumer affairs
  • Pharmacology
  • Clinical trials
  • Medical devices and in vitro diagnostics industries

The nominated members will have a three year term in office.

 

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January 9, 2015   No Comments

Merck India Sells Consumer Care Business to Bayer India

Bayer AG has globally acquired the marketing and distribution of consumer care products from Fulford India, a Merck & Co Inc., subsidiary, with effect from January 1, 2015. As part of the global transaction, products such as Alaspan, Polaramine, Tinaderm have been transferred to Bayer Pharmaceuticals Private Ltd.

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January 3, 2015   No Comments

Food Safety Regulatory Systems to Be Strengthened in India

The National Health Mission program of the health and family welfare ministry in India aims to revamp the food safety regulatory systems both at the federal and state levels at a cost of $28 million.

The federal Food Safety and Standards Authority of India headquarters, its field offices, e-governance and food safety surveillance, will be strengthened and upgraded. Plans are afoot to improve the federal-level laboratories and establish the National Food Science and Risk Assessment Center.  

At the state level, food testing laboratories will be modernized and manpower capacity increased. Holding training camps for creating awareness among citizens and food business operators, and setting up surveillance systems to reduce food adulteration will be implemented, FnBnews.Com reports.

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January 3, 2015   No Comments

Philips India to Offer Healthcare Consultancy and Management Services

Philips India, a subsidiary of Royal Philips, the Netherlands-based diversified technology company is planning to offer services such as healthcare transformation, hospital infrastructure advisory and remote monitoring of ICUs, instead of confining itself to the healthcare equipment space. It expects these services to account for 15 percent of its healthcare revenues from India in the next four years.

Sameer Garde, president, South Asia, Philips Healthcare told the  Business Standard newspaper that home healthcare and hospital infrastructure advisory services are going to be big areas that promise exponential growth for Philips.

According to estimates, the overall Indian health care market is $65 billion, of which the hospital supplies and health care equipment segment is believed to be only around $4.5-$5 million.

Philips Healthcare

Philips Healthcare

Garde projected  that India would need approximately 600,000 and 700,000 additional beds over the next five to six years, which created potential opportunities for business upwards of $25-30 billion. “While the existing hospitals would look at expanding their capabilities, a lot of new properties would also come up. We want to provide end-to-end services in this space, starting from hospital design and development, engineering, procurement and program management,” Garde added.

Philips also aims to expand its tele-health or eICU program to cover a greater number of smaller cities and rural areas. Under this program, hospital chains in bigger cities with experienced physicians served as command centers that managed ICUs in smaller cities and towns remotely. Philips has already connected around 700 ICU beds of hospitals across some 8-10 cities. In the next four years, it expects the number to grow 15-20 times.

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January 3, 2015   No Comments