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.
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 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.
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.
Virginity testing — a gynecological examination conducted under the belief that it determines whether a woman or girl has had vaginal intercourse — must end, says UN Human Rights, UN Women and the World Health Organization (WHO).
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.
Following a meeting in Delhi earlier this month, MHRA will send intelligence to the Directorate of Revenue Intelligence (DRI), enabling them to target regions suspected of sending unlicensed medicines into the UK.
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.
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.
The Union Cabinet chaired by Prime Minister Shri Narendra Modi has approved the signing of an Agreement between India and Uzbekistan on cooperation in health and medical science.