Clinical Decision Support Systems

21/01/2023

The Policy Times aims to unfold social, economic, business, policy and practical issues that matter to India and the world especially the youth and women who would require to develop practical understanding about long-term developmental issues.

17/11/2022

The vaccine to inoculate people against the Kyasanur forest disease (KFD), a potentially fatal tick-borne illness, had poor potency and effectiveness for nearly two decades, an investigation has found.
Despite the ineffectiveness being clear to government bodies for several years, the vaccine was used until October this year.
The investigation says India’s drug regulator did not perform any of the duties it was supposed to, while the National Institute of Virology provided dubious advice to the manufacturer.

Government, Health, The Sciences Systemic Failures Led to Ineffective KFD Vaccine Being Used for Decades: Report 17/11/2022 The Wire Staff Read Next Why India’s Hydel Push in Northeast Has Indigenous Peoples Are Worried Representative image of a tick. Photo: Marino Linic/Unsplash The vaccine to in...

16/11/2022

A STAT review of documents detailing the steps taken toward government approval found that regulators endorsed the vaccine, called Covaxin, despite discrepancies in the number of clinical trial participants. Moreover, questionable changes were made to the trial protocols — which are established procedures for testing a vaccine or medicine — to expedite the approval process.

A STAT review of documents on Bharat Biotech's Covid-19 vaccine found that regulators endorsed the vaccine despite discrepancies in the number of enrollees.

06/10/2022

The 66 deaths in the Gambia are not the first tragedy caused by sub-standard drugs manufactured in India. In the past, several low-and-middle-income countries (LMICs) have either complained about receiving sub-standard drugs from India or have blacklisted Indian firms – damaging Indian claims of being the “pharmacy of the world”. These incidents also raise questions about the laxity shown by Indian authorities in acting against the erring firms. One such example can be understood from a complaint from Vietnam.
On December 23, 2013, Deepak Mittal, the Indian consul general at Ho Chin Minh City in Vietnam, wrote to India’s health ministry that the former had blacklisted 46 Indian companies for supplying substandard drugs.
Indian-manufactured cough syrups also have a history of causing DEG poisoning due to contamination, even within the country. At least 13 children died in Himachal Pradesh earlier this year due to the consumption of syrup that was contaminated with DEG. Before this tragic event, drug regulators had found the firm’s drugs to be substandard at least 19 times – yet it continued to operate, just like Maiden Pharmaceuticals continued to operate even after the Kerala and Gujarat government flagged the substandard drugs.
In The Truth Pill: The Myth of Drug Regulation in India, Dinesh Thakur – the Ranbaxy whistleblower – and Prashant Reddy – the lawyer mentioned earlier in the story – talk about DEG poisoning leading to the death of 11 children died in Jammu in 2019. They too suffered from acute kidney injuries – just like the Gambian children.

Maiden also claimed that one of its manufacturing plants had a WHO certificate – whereas the WHO denied this to The Wire.