The Central Drugs Standard Control Organisation (CDSCO) released draft guidelines for developing vaccines in the grave situation of COVID-19, taking it as a special case. The Central Drug Authority came with the guidelines considering the Drug and Cosmetics Rules, 1940 and New Drugs and Clinical Trials Rules, 2019, and the international perspectives of World Health Organization (WHO), United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) guidelines, and other applicable guidelines of CDSCO.
After the outbreak of COVID-19, the World Health Organization (WHO) has said that hand hygiene is important to prevent the virus’s spread. Hand hygiene guidelines of WHO recommends the use of an alcohol-based hand rub for 20-30 seconds when hands are not dirty.
CliniExperts successfully helped in getting approval of Edinburgh Genetics Colloidal Gold Immunoassay and Whole Blood Collection kits for testing COVID-19.The pre-approved COVID-19 testing kits by the Medicines and Healthcare Products Regulatory Agency (MHRA, UK) are now also approved by the Central Drugs Standard Control Organization (CDSCO) and validated by Indian Council of Medical Research (ICMR).
RealCycler CORO-G Kits v.5.3 is Real-time PCR Test Kit, using Taqman-like hydrolysis probes technology, in combination with CHIC technology for the design of the internal amplification control. The kits allows the detection of Coronavirus SARS-CoV-2 and Sarbecovirus E gene RNA in clinical samples using realtime PCR.
A growing number of research centres, hospitals are investigating antibody testing and blood-plasma therapy as a way to fight the new coronavirus in sick patients. People who survive an infectious disease like COVID-19 are left with antibody-rich blood plasma or convalescent plasma made to fight off the virus. Researchers are predicting convalescent plasma can be a lifeline for corona virus-infected individuals. The Ministry of Health and Family Welfare, Government of India on 27th June 2020, came out with CLINICAL MANAGEMENT PROTOCOL: COVID-19 Version 4.
COVID-19 is disrupting global distribution on a scale unseen in recent times, creating extreme challenges for the supply chain of imported drugs and healthcare products. Increased border controls and customs regulations resulting in longer wait times and lack of capacity for long-haul and last-mile fulfillment create extreme challenges for the pharmaceutical industry.The Central Drugs Standard Control Organisation (CDSCO) has extended permission to three months to import drugs whose residual shelf life is less than 60 percent.
The Central Drugs Standard Control Organisation (CDSCO) and Review Committee on Genetic Manipulation (RCGM) recommend the rapid processing of recombinant vaccine development during COVID-19 pandemic under Rapid response Regulatory Framework. All the applications will be screened depending on the proper data and population.
Ethics preparedness is the capability of the public health system to protect and have the ability to quickly respond to by having in place an ethical framework that would build trust and guide measures to recover from health emergencies. ICMR Bioethics unit, NCDIR, Bengaluru, along with COVID19 National Ethics Committee (CoNEC), released a guidance document regarding the ethical conduct of clinical research in India.
Biocan Diagnostic Inc brings in India a rapid testing kit named Tell Me Fast. A rapid test for the qualitative detection and differentiation of novel coronavirus (COVID-19) IgG & IgM antibodies in human whole blood, serum, and plasma samples, approved by the Central Drugs Standard Control Organisation (CDSCO) and (United States Food and Drug Administration) USFDA. CliniExperts helped in the rapid approval of the testing kit Tell Me Fast developed by Biocan Diagnostics Inc in India