Government News

Statement on NHLBI decision to pause the CONCERT-HF trial

  • Posted on: 31 October 2018
  • By: Shalini.Sharma

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is pausing the CONCERT-HF trial, which involves patients with chronic heart failure. Recent calls for the retraction of journal articles in related fields of cell therapy research have raised concerns about the scientific foundations of this trial. While none of the articles in question derive from the CONCERT-HF trial itself, the NHLBI convened CONCERT-HF’s Data and Safety Monitoring Board (DSMB) out of an abundance of caution to ensure the study continues to meet the highest standards for participant safety and scientific integrity. Informed by the DSMB recommendations of October 25, 2018, the NHLBI is pausing the trial. While the DSMB did not have any participant safety concerns, this pause enables the DSMB to complete its review.

NIH selects first scholars in pioneering program to enhance diversity within in-house research program

  • Posted on: 26 October 2018
  • By: Shalini.Sharma

Thirteen researchers have been selected for the inaugural class of the National Institutes of Health’s Distinguished Scholars Program (DSP). The NIH-wide pilot program is designed to build diversity within the NIH Intramural Research Program, comprised of NIH scientists, by facilitating hiring and career progression of tenure-track investigators who have demonstrated a commitment to promoting diversity and inclusion in the biomedical research workforce.

NITI Aayog launch Guidelines for Public Private Partnership for Non Communicable Diseases

  • Posted on: 23 October 2018
  • By: Shalini.Sharma

NITI Aayog launched the Guidelines and Model Concessionaire Agreement, MCA for Public Private Partnership, PPP for Non Communicable Diseases. The documents have been designed to supplement efforts for provision of prevention and treatment services of non-communicable diseases related to Cardiac Sciences, Oncology, and Pulmonary Sciences at the district hospitals especially in tier 2 & 3 cities.

DoP's guidelines for implementation of public procurement order For the procurement of goods and services in medical devices

  • Posted on: 23 October 2018
  • By: Shalini.Sharma

The department of pharmaceuticals (DoP) has come out with guidelines on implementation of Public Procurement (Preference to Make in India) order, 2017 (PPP-MII Order) related to procurement of goods and services in medical devices, partially diluting requirement of US FDA/CE certification in public procurement.

Government Strengthens Food Safety Ecosystem, notifies FSSAI Recruitment Regulations

  • Posted on: 16 October 2018
  • By: Shalini.Sharma

In yet another landmark step to strengthen the food safety and nutrition ecosystem in the country, the government formally notified the very first set of Recruitment Regulations of the Food Safety and Standards Authority of India (FSSAI) in the official gazette on 11.10.2018. This follows closely on the heels of another important milestone a few weeks ago, when almost 500 new posts were created to strengthen the functioning of the Authority.

Shri J P Nadda inaugurates ‘2nd World Conference on Access to Medical Products: Achieving the SDGs 2030’

  • Posted on: 12 October 2018
  • By: Shalini.Sharma

At the function, Shri J P Naddareleased the Position Paper and launched the Information Sharing Platform Gateway for South-East Asia Regulatory Network (SEARN) developed by Centre for Development of Advanced Computing, which will promote regulatory and health collaboration among the countries of the South-East Asia Region.

Indian government stands committed to ensure safety of vaccines

  • Posted on: 4 October 2018
  • By: Shalini.Sharma

India has continued WHO engagement to support India maintain international quality surveillance for poliovirus detection in the country.

There have been reports in a section of the print media mentioning that bivalent oral polio vaccine supplied by a particular manufacturer had some quality issues. India was certified polio-free in March 2014 and continues to be so. India continues to remain vigilant against all three types of polioviruses. The last polio case due to wild poliovirus in the country was detected on 13 January 2011.