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The Latest Breaking News from CDSCO

Emcure Pharma gets CDSCO nod to market Poviztra for fatty liver treatment

Emcure Pharmaceuticals announced its brand Poviztra is now available for fatty liver treatment. This follows regulatory approval for treating metabolic dysfunction-associated steatohepatitis in adults. Poviztra contains innovator semaglutide manufactured in Europe by Novo Nordisk. The approval expands access to treatment for this progressive liver disease. This marks a significant milestone…

The Economic Times

Why CDSCO and BEE have not kept pace with the industries they oversee

CDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade back, the organisation was recommended a benchmark of 1 inspector for every 50 manufacturing units. Yet, in end-2023, it carried a strength of barely 200 inspectors against a sanctioned strength…

The Economic Times

Wockhardt shares jump 8%, extend rally after CDSCO nod for Zaynich antibiotic

Wockhardt shares surged after the company received CDSCO approval for its breakthrough antibiotic Zaynich in India. Strong Phase 3 trial results and the drug’s potential to treat severe drug-resistant infections boosted investor sentiment, helping the stock extend recent gains despite technically entering overbought territory after a sharp rally.

The Economic Times

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A trail of grief, little accountability: The Marion Biotech story after 68 children deaths

This is the third part of an investigative series examining pharmaceutical companies linked to the deaths of children from contaminated medicines, and the regulatory failures that allowed them to keep operating. It is supported by the Thakur Foundation. The foundation has not exercised any editorial control over the project.

Newslaundry

Indian pharma firms flood west Africa with powerful opioids despite crackdown: AFP investigation

Indian pharmaceutical firms are exporting millions of dollars worth of powerful tapentadol opioids to West Africa, fueling a deadly drugs epidemic, according to an AFP investigation. Researchers found these high-strength pills are being added to the addictive "zombie drug" kush, leading to a surge in overdose deaths and addiction across…

The Economic Times

Drugmakers must report safety data from launch date, not approval date: CDSCO

India's drug regulator has issued a new directive for pharmaceutical companies. Periodic Safety Update Reports for new drugs must now be submitted from the actual market launch date. This change aims to strengthen patient safety monitoring. Previously, reports were based on the regulatory approval date. The new rule ensures that…

The Economic Times

Indian firms dumped Rs 1,000 crore of unapproved opioid pills into West Africa’s drug crisis

This article is the result of a collaboration with Netherlands-based open-source media outlet Bellingcat. Read Bellingcat’s editorially independent coverage here.

Newslaundry

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After 66 child deaths, a clean chit, and a ‘vanishing act’: Maiden Pharma is coming back, rebranded

This is the second part of an investigative series examining pharmaceutical companies linked to the deaths of children from contaminated medicines, and the regulatory failures that allowed them to keep operating. It is supported by the Thakur Foundation. The foundation has not exercised any editorial control over the project.

Newslaundry

Dead children, dirty drugs, a giant ‘racket’: The curious case of Digital Vision Pharma

This is the first part of an investigative series examining pharmaceutical companies linked to the deaths of children from contaminated medicines, and the regulatory failures that allowed them to keep operating. This series is supported by the Thakur Foundation. The foundation has not exercised any editorial control over the project.

Newslaundry

Mounjaro: As Eli Lilly's blockbuster anti-obesity drug comes to India, expert lists key side effects

Eli Lilly's blockbuster drug 'Mounjaro' was launched in India on Thursday. The pharma manufacturer said it has launched a first-of-its-kind medication for obesity and type 2 diabetes in the country after obtaining approval from the Central Drugs Standard Control Organisation (CDSCO). The company said it has introduced Mounjaro in a…

The Times of India

How I lost eight out of nine cases before the Chief Information Commissioner

Over the last decade we have read many an obituary about the Right to Information Act. Let me add to that long list of obituaries by narrating how I lost eight out of nine cases before one Information Commissioner – Heeralal Samariya, a former IAS officer who was first appointed…

Newslaundry

No change in status quo for sales and distribution of emergency contraceptive pills

The sales and distribution of Emergency Contraceptive Pill (ECP) brands, including i-Pill and Unwanted - 72, will remain unchanged, sources with the Central Drugs Standard Control Organisation (CDSCO) said on Friday? Read further on Dynamite News:

Dynamite News

Quality lapse by major pharma firms in India, 53 drugs and leading companies under scrutiny

India's drug regulator, the Central Drugs Standards Control Organisation (CDSCO), has listed more than 50 drugs as "Not of Standard Quality (NSQ) Alert" in its latest monthly report. This list includes widely used medicines such as calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medicines.

The Times of India

India develops Monkeypox detection RT-PCR kit

The World Health Organisation (WHO) has announced its second public health emergency of International concern due to Monkey Pox. Read further on Dynamite News:

Dynamite News

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The Hindu

TB vaccine MTBVAC gets CDSCO nod for phase II trials

CDSCO approves Bharat Biotech's phase II clinical trial for TB vaccine in India, focusing on safety and immunogenicity.

The Hindu

Drug regulator warns about Meropenem, Disodium

CDSCO warns against unapproved drugs, specifically "New Drugs", citing examples of Meropenem and Disodium EDTA.

The Hindu

Union Cabinet approves memoranda on health products with Netherlands, Dominican Republic, Ecuador

“The Union Cabinet on January 18 approved separate memorandum with the Netherlands, Dominican Republic and Ecuador on cooperation in the field of medical products regulation,” an official statement said.

Newslaundry

Exclusive: AAP govt procured drugs from 2 blacklisted pharma firms with many failed quality tests

Six drugs from six pharma firms have fuelled a tussle between the Centre and the Delhi government, with both sides trying to blame each other for substandard medicines making their way to the capital’s government hospitals.

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The Hindu

Two labs in India take on the bulk of testing for cough syrup samples for export

India is taking steps to ensure quality of drugs exported, with 15 Central and State-run labs testing cough syrup samples for export. CDSCO has increased posts and amended rules to ensure safety and stability of drugs. Private players have also been brought in to speed up process.

The Hindu

Batches of India-manufactured syrups for cough, allergic rhinitis found contaminated: CDSCO

CDSCO report finds two Indian manufacturers' cough and allergy syrups contain contaminants; WHO issued alerts on contaminated cold-cough syrups exported by India. 48 samples declared "not of standard quality" and "spurious" of 1,166 tested in Aug. Gujarat firm asked to suspend production; TN-based firm's COLD OUT syrup found to have…

The Hindu

NHRC alarmed over reported circulation of falsified liver, cancer drugs

After the alert from the WHO, the CDSCO has asked the State regulators, doctors and patients to remain vigilant about two medicines.

The Hindu

Drugs regulator issues alert after pharma firm Abbott India recalls antacid syrup Digene Gel

The public notice issued by the apex drug controller on its website said: “The impugned product may be unsafe and its use may result in adverse reaction.”

The Hindu

Hyderabad-based Bharat Biotech recalls typhoid vaccine batch owing to substandard quality

It added that the recall was initiated utilising the principle of abundant precaution based on test results of field samples by the Central Drugs Laboratory.

The Hindu

CDSCO starts probe into Indian-manufactured eye drops leading to infection

The Central Drugs Standard Control Organisation (CDSCO) has initiated an investigation into a complaint raised by the Sri Lankan Ministry of Health alleging that eyedrops manufactured in India are linked to eye infection in more than 30 people.

The Hindu

Centre considering testing drugs at govt. laboratories before exporting

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.

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