: India’s drug approval system is broken but a proposed new law does nothing to fix it #IndiaNEWS One of the great revelations about India’s drug regulatory framework during the pandemic was the

India’s drug approval system is broken but a proposed new law does nothing to fix it #IndiaNEWS
One of the great revelations about India’s drug regulatory framework during the pandemic was the fact that it simply does not know how to approve new drugs. Many of the new drugs approved by the Drug Controller General of India such as Favipiravir, Itolizomab and Virafin never found mention in the government’s own treatment guidelines for Covid-19.Quite often, the Drugs Controller General of India kept dropping phrases such as “emergency use authorisation�?, “clinical trial mode�? and others while approving these new drugs and vaccines despite the lack of adequate clinical trial data, except that none of these phrases actually find a mention in the law.The process was so chaotic that at one point, Biocon’s head for regulatory affairs and the Drugs Controller office contradicted each other on the provision of law under which the company’s drug Itolizumab was approved for treating Covid-19.ZyCoV-D® as a two-dose vaccine receives EUA from DCGIThe two-dose regimen has been approved in the age group of 12 years and above.With this approval, the vaccine will now be administered on Day 0 and Day 28.@MoHFW_INDIA @tapasjournalist #COVID19Vaccine pic.twitter.com/1LyITmYaKF— DD News (@DDNewslive) April 26, 2022 The government’s decision in July to introduce the Drugs, Cosmetics & Medical Devices Bill, 2022, to replace the colonial-era drug regulatory law, was an excellent opportunity to fix the broken drug regulatory process.The main concern,...Read more

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