India is seeking approval from the European Medicines Agency (EMA) for Covishield, one of its COVID-19 vaccines. Covisheld approval is being sought on an emergency authorisation basis from the bloc’s apex medical regulatory body. The Serum Institute of India (SII) manufactures Covishield, which is the Indian variant so to speak of the COVID-19 vaccine produced […]
regulation
Pfizer vaccine on the cusp of securing Indian approval, CEO says
The Pfizer vaccine against COVID-19 is on the verge of securing approval for use in India. This is according to the drugmaker’s chief executive officer Albert Bourla who, speaking at a virtual event, said they were in the “final stages” of receiving the nod and said “I hope very soon we will finalise an agreement […]
Accelerated approval for Pfizer, SII vaccines?
Following the requests by both Pfizer and the Serum Institute of India (SII) for emergency use authorisation for their respective COVID-19 vaccine candidates, the Union Government is considering an accelerated approval process. “We are in the process of reviewing,” said a senior government official quoted by Reuters. “It is an accelerated reviewing process, which is […]
Emergency use authorisation sought by SII, Pfizer
The Serum Institute of India (SII) is seeking emergency use authorisation for Covishield, also known as the ‘Oxford Vaccine’. Pfizer has done the same for its vaccine candidate. Phase-III trials of Covishield – made by the University of Oxford in collaboration with AstraZeneca – are underway in various parts of the country, conducted by the […]
Assisted Reproductive Technology Regulation Bill, explained
The Assisted Reproductive Technology Regulation Bill, 2020 – one the Government has billed as “historic” – has won the approval of the Union Cabinet in a significant overture towards regulation of the assisted reproductive technology sector. Prime Minister Narendra Modi chaired the Cabinet meeting where the Bill secured the approval of ministers. The legislation outlines […]
Medical devices regulation: Boon or bane?
Central regulation of medical devices is to come into effect in India as of April, it has been reported. Once the shift has come into force at the beginning of the forthcoming fiscal year, all medical devices and equipment for the purposes of “diagnosis, monitoring, treatment, investigations and for supporting or sustaining life” will be […]
The Medical Devices Bill, explained
Government-run think tank Niti Aayog will roll out the Medical Devices Bill according to media reports, marking a significant overhaul of the regulatory apparatus surrounding medical devices in India. “Niti has been engaged in developing a Medical Devices Bill. The purpose of the draft Bill is to ensure that medical devices in lndia are safe […]
Opposition to Central medical device regulation
Government think tank Niti Aayog has voiced opposition to the Health Ministry’s proposal to bring the regulation of medical devices under the authority of the Central Drugs Standard Control Organisation (CDSCO), effectively bringing the manufacture and sale of all medical devices into the purview of the Centre. The Union Health Ministry has put into place […]