Relaxation Of Drug License For Selling And Stocking Hand Sanitizers
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.
Read MoreRCGM And CDSCO Recommends Fast Track Processing Of Recombinant Vaccines Applications For COVID-19
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.
Read MoreEthics Committee Guidance Amid COVID-19 Pandemic In India
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.
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CliniExperts Aided The Faster Approval Of Edinburgh Genetics Colloidal Gold Immunoassay And Whole Blood Collection COVID-19 Kits
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).
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What Should You Know About Manufacturing Licenses For New API And Formulations In India?
There is a constant demand from customers and global competitive pressure to produce active pharmaceutical ingredients (API) on the pharmaceutical manufacturers in India. The coronavirus pandemic has created the need for an API manufacturing hot-spot other than China as India has the potential to manufacture new API and formulations. To manufacture or import Active Pharmaceutical Ingredient (API)/drugs to India, the company or the organization should seek prior approval from the Drugs Controller General of India (DCGI) for licensing and distribution in the country.
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Regulatory Approvals And Pathway For The Manufacture Of Ventilators Amid COVID-19
India is presently grappling with an acute shortage of ventilators in its fight against coronavirus. Ventilators do not fall under any regulated medical device category at present in India. Ventilators may also be coming under the regulated category soon. Once this happens the present regulatory pathways followed for ventilators will change and manufacturers or importers need to apply for manufacturing license or import license.
Read MoreRegulation/Guidelines
Accelerated Approval Of RealCycler CORO-G Real Time PCR Kits By CliniExperts
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.
Regulation/Guidelines
CDSCO Notified Information On Convalescent Plasma In COVID-19
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.
Regulation/Guidelines
CDSCO Extends Timeline For Import Of Drugs With Residual Shelf Life Less Than 60 Percent Till Oct 31
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.