Health

Council of Scientific & Industrial Research (CSIR), and Laxai Life Sciences Pvt. Ltd., Hyderabad, have been given the regulatory approval by the Drugs Controller General of India (DCGI) to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in the improvement of clinical outcomes during the treatment of COVID-19 patients. The partner CSIR institutes in this important clinical trial are the CSIR-Indian Institute of Chemical Technology (IICT), Hyderabad and CSIR-Indian Institute of Integrative Medicine (IIIM), Jammu.

The Novavax trials conducted on 29,960 people in the US and Mexico have delivered results that equal the Pfizer and Moderna jabs and do better than Johnson and Johnson, but regulatory clearance appears distant as an overflowing vault of vaccines has diminished the need for emergency use approvals. Additional EUAs are not required under US law after enough dosages are available to meet domestic demands.

Council of Scientific and Industrial Research (CSIR)’s Lucknow-based constituent laboratory Central Drug Research Institute (CDRI) and Marc Laboratories Ltd, India have come together to develop a new safer drug for heart attack and stroke. They have signed the license agreement for developing drug for coronary and cerebral artery diseases.

Indian Institute of Technology, Ropar has developed a device ‘Jivan Vayu’ which can be used as a substitute of CPAP machine. However, this is Nation’s first such device which functions even without electricity and is adapted to both kinds of oxygen generation units like O2 cylinders and oxygen pipelines in hospitals. These provisions are not available in otherwise existing CPAP machines.

Dozee, a Department of Biotechnology (DBT) and its PSU Biotechnology Industry Research Assistance Council (BIRAC) funded start-up offers ‘contact-free monitoring of the vital parameters of the patients on a normal bed. The innovation has already resulted in the upgrading of over 4,000 hospital beds for Step-Down ICUs across 35 districts in India. In the last months, Dozee has already served over 30,000 patients, saved over 65,000 nursing hours and prompted over 750 timely ICU transfers through its Early Warning System.

India’s first official beyond visual line of sight (BVLOS) medical drone delivery experiment is scheduled to begin this week in Gauribidanur, some 80km from Bengaluru.

It is noted that a renowned international magazine in its article has speculated that ‘India has suffered perhaps five-to-seven times “excess deaths” than the official number of COVID-19 fatalities’. It is a speculative article, which is without any basis and seems to be misinformed.

The unsound analysis of the said article is based on extrapolation of data without any epidemiological evidence.

Studies which are used by the magazine as an estimate of excess mortality are not validated tools for determining mortality rate of any country or region.

The so called “evidence” cited by the magazine is a study supposedly done by Christopher Laffler of Virginia Commonwealth University. An internet search of research studies in scientific database such Pubmed, Research Gate, etc., did not locate this study and the detailed methodology of this study has not been provided by the magazine.

Another evidence given is the study done in Telengana based on insurance claims. Again, there is no peer reviewed scientific data available on suchstudy.

Two other studies relied upon are those done by Psephology groups namely “Prashnam” and “C-Voter” who are well versed in conducting, predicting and analysing poll results. They were never ever associated with public health research. Even in their own area of work of psephology, their methodologies for predicting poll results have been wide off the mark many times.

By their own submission, the magazine states that ‘such estimates have been extrapolated from patchy and often unreliable local government data, from company records and from analyses of such things as obituaries’.

Union Government has been transparent in its approach to COVID data management. As early as May 2020, to avoid inconsistency in number of deaths being reported, Indian Council of Medical Research has issued ‘Guidance for appropriate recording of COVID-19 related deaths in India’ for correct recording of all deaths as per ICD-10 codes recommended by WHO for mortality coding. States and UTs have been urged through formal communications, multiple video conferences and through deployment of Central teams for correct recording of deaths in accordance with laid down guidelines.

Union Health Ministry has also regularly emphasized the need for a robust reporting mechanism for monitoring district wise cases and deaths on a daily basis. States consistently reporting lower number of daily deaths were told to re-check their data. A case in point is the Union Government writing to the State of Bihar to provide detailed date and district wise break-up of the reconciled number of deaths to Union Health Ministry.

It’s a well-known fact that there shall always be difference in mortality recorded during a profound and prolonged public health crisis such as COVID pandemic and well conducted research studies on excess mortalities, usually done after the event when data on mortalities are available from reliable sources. The methodologies for such studies are well established, the data sources are defined as also the valid assumptions for computing mortality.