Bharat Biotech's Krishna Ella suggests merging State drugs regulators with Central body to ensure 'one quality one standard'
2 years, 1 month ago

Bharat Biotech's Krishna Ella suggests merging State drugs regulators with Central body to ensure 'one quality one standard'

The Hindu  

All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation to ensure "one quality one standard" for Indian drugs, Bharat Biotech's Executive Chairman Dr. Krishna Ella has suggested. The latest instance was on Friday, when the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop linked allegedly to vision loss in the U.S. Before that, India-made cough syrups were allegedly linked to children deaths in the Gambia and Uzbekistan last year. All state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation and that will solve the problem", Mr. Ella said. A day after its plant was inspected by Indian drug regulatory bodies over allegations that its eye drop was linked to vision loss in the US, Tamil Nadu-based Global Pharma Healthcare on Saturday was asked to stop manufacturing all ophthalmic products till the inquiry is completed.

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History of this topic

Centre considering testing drugs at govt. laboratories before exporting
1 year, 10 months ago

Centre considering testing drugs at govt. laboratories before exporting

The Hindu  

Amid quality issues being raised globally for the cough syrups exported by Indian firms, the Centre is actively considering a proposal of testing drugs at government laboratories before they are dispatched to other countries. The apex drug regulatory authority, the Central Drugs Standard Control Organisation has proposed testing the drugs at government labs before exporting, official sources said. The analysis …

Govt plans common drugs standards for all state regulators
2 years ago

Govt plans common drugs standards for all state regulators

Hindustan Times  

The Union health ministry is considering formulating common standards for drug regulators at the Centre and the states and maintaining a central database to better regulate the manufacturing, sale, and distribution of drugs, according to people familiar with the matter -- a move likely triggered by recent deaths globally that were linked to consumption of drugs manufactured in India. Once …

UPSC to Interview 3 Officers for Position of Next Drug Controller General of India
2 years, 2 months ago

UPSC to Interview 3 Officers for Position of Next Drug Controller General of India

News 18  

The DCGI is the head of the Central Drugs Standard Control Organisation, which is the apex drug regulatory body that regulates medicines, vaccines and medical devices. The top contenders referred by the health ministry to the commission include three officers – Dr VG Somani, Dr Rajeev Singh Raghuvanshi and Dr Jai Prakash. A postgraduate in pharmacy and doctorate in pharmaceutical …

Cough syrup deaths | After inspection, India stops Maiden Pharma unit from making drugs
2 years, 5 months ago

Cough syrup deaths | After inspection, India stops Maiden Pharma unit from making drugs

The Hindu  

The Central Drugs Standard Control Organisation and Haryana State Drugs Controller have directed a stop to all manufacturing activity at Maiden Pharmaceuticals Limited in Sonepat on grounds of deficiencies found following local inspection of the company’s facilities, a senior Health Ministry official has confirmed. The World Health Organization had on September 29 informed India’s national drug regulator that it was …

DC Edit | Time to clean up pharma
2 years, 5 months ago

DC Edit | Time to clean up pharma

Deccan Chronicle  

The Central Drugs Standard Control Organisation has initiated an investigation after the World Health Organisation issued an alert following the death of 66 children in the West African nation of Gambia. It is perhaps for the first time that an Indian drug manufacturer is in the dock for causing deaths in a foreign nation. The $40 billion Indian pharmaceuticals industry …

Drug regulator initiates probe after WHO links children deaths in Gambia to cough syrup made in India
2 years, 5 months ago

Drug regulator initiates probe after WHO links children deaths in Gambia to cough syrup made in India

The Hindu  

A probe has been initiated by India's drug regulator after the WHO issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said. The sources said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the …

Panel Under Drug Regulator to Meet Soon to Decide Ban on Cocktail Meds, Codeine-based Cough Syrups
2 years, 5 months ago

Panel Under Drug Regulator to Meet Soon to Decide Ban on Cocktail Meds, Codeine-based Cough Syrups

News 18  

The apex panel under the drug regulatory body of India is set to decide the fate of cocktail medicines, including codeine-based cough syrups soon, News18.com has learnt. “The DTAB committee is slated to meet coming Monday to start deliberations over the FDC medicines, including codeine-based formulations,” the government official privy to the development told News18.com. The DCGI has been asked …

Health Matters: India Must Regulate Drug Regulatory Body First. Bribery Controversy Blessing in Disguise
2 years, 8 months ago

Health Matters: India Must Regulate Drug Regulatory Body First. Bribery Controversy Blessing in Disguise

News 18  

The Indian drug regulatory agency, CDSCO, is stuck in its own web – the trap it created with its uncanny silence may finally start pushing the agency for answers. The other officials involved included a senior executive of the pharma company Biocon Biologics, two others indirectly involved with Biocon, and a few other officials of India’s apex drug regulatory agency. …

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