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CDSCO

34 more drugs likely to be banned, says CDSCO

by Shawn Butlere
34 more drugs likely to be banned, says CDSCO

New Delhi: Following a crackdown on 156 fixed dose combination (FDC) drugs after finding them without therapeutic justification and even unsafe in several cases, a top official in the Central Drugs Standard Control …

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Categories Health

Blockbuster diabetes obesity drug tirzepatide gets India launch nod

by Shawn Butlere
Blockbuster diabetes obesity drug tirzepatide gets India launch nod

New Delhi: A top panel under the Central Drugs Standard Control Organisation (CDSCO) — India’s national regulatory body for pharmaceuticals and medical devices — has recommended regulatory approval to import …

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Categories Health

Drug regulator’s plan to bring all nicotine replacement therapies under prescription gets ICMR nod

by Shawn Butlere
Drug regulator’s plan to bring all nicotine replacement therapies under prescription gets ICMR nod

New Delhi: A proposal by the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator, to classify all nicotine replacement therapies (NRT) — treatments aimed at helping people stop the use …

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Drug regulator CDSCO asks all medical device makers to ‘self-report adverse events’ to mitigate risks

by Shawn Butlere
Drug regulator CDSCO asks all medical device makers to ‘self-report adverse events’ to mitigate risks

New Delhi: India’s apex drug regulator has asked medical device makers to self-report all adverse events related to their equipment through the Centre’s Materiovigilance Programme of India (MvPI), ThePrint has learnt. …

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Categories Health

Central regulator to now give NOC for export of new, unapproved medicines after safety concerns

by Shawn Butlere
Central regulator to now give NOC for export of new, unapproved medicines after safety concerns

New Delhi: After a string of adverse events in the last two years, India’s apex drug regulator will from 15 May onwards grant manufacturing licenses for drugs that are banned …

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Drug regulator tightens sampling norms to test quality of medicines

by Shawn Butlere
Drug regulator CDSCO asks all medical device makers to ‘self-report adverse events’ to mitigate risks

New Delhi: India’s apex drug regulator has come up with new guidelines for sampling of drugs, cosmetics and medical devices amid persistent concerns around the quality of medicines manufactured in the …

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Categories Health

After prohibiting popular FDC for kids under 4, drug regulator scrutinises other cold & cough remedies

by Shawn Butlere
After prohibiting popular FDC for kids under 4, drug regulator scrutinises other cold & cough remedies

New Delhi: India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), last month instructed drugmakers not to sell a popular fixed dose combination (FDC) medicine, indicated as a …

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Categories Health

Indian pharma firms now liable to recall defective drugs

by Shawn Butlere
Indian pharma firms now liable to recall defective drugs

New Delhi: For the first time in India, defective or adulterated drugs can be recalled even if they reach the market at large. The new mandate is part of the changes …

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Categories Health

Global pharma majors pitch for faster approval of innovative drugs in India but CDSCO remains cautious

by Shawn Butlere
Global pharma majors pitch for faster approval of innovative drugs in India but CDSCO remains cautious

New Delhi: Global pharmaceutical giants are pushing the Central Drugs Standard Control Organisation (CDSCO) for faster approvals by granting parallel market authorisation that will allow drugs and innovative therapies to …

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Categories Health

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