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Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon
1 year, 8 months ago

Drugs Controller Told to Filter Out ‘Cocktail Drugs’ from Indian Market, Ban Likely Soon

News 18  

The central government has told the country’s apex drugs controller to regulate the market of fixed-dose combination drugs in India – an issue pending for several months now. The Central Drugs Standard Control Organisation, the office of the Drugs Controller General of India, has already started working on this and the ban on these “cocktail drugs” may be announced within …

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Technocrat, Nationalist, Science-lover, Problem-solver: Meet New DCGI Rajeev Singh Raghuvanshi
1 year, 10 months ago

Technocrat, Nationalist, Science-lover, Problem-solver: Meet New DCGI Rajeev Singh Raghuvanshi

News 18  

The appointments committee of the cabinet has approved the proposal to make Rajeev Singh Raghuvanshi the Drugs Controller General of India – the top health regulatory job in the country. In his last assignment, Raghuvanshi served as the secretary-cum-scientific director of the Indian Pharmacopoeia Commission, and is known for his “problem-solving approach” among his peers and juniors. Another government official, …

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'Two Days to Respond': Top e-Pharmacy Firms under Scanner of Modi Govt, Show-cause Notice Issued
1 year, 10 months ago

'Two Days to Respond': Top e-Pharmacy Firms under Scanner of Modi Govt, Show-cause Notice Issued

News 18  

E-pharmacies are under the scanner of the Narendra Modi government. What notice says Sent on February 10, the notice titled “Online sale and distribution of the Drugs in the country” straightforwardly asked the e-pharmacists to demonstrate “why action shall not be taken against you for the sale or stock or exhibit or offer for sale or distribution of drugs in …

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UPSC Recommends Rajeev Singh Raghuvanshi as Next Drug Controller General of India
1 year, 10 months ago

UPSC Recommends Rajeev Singh Raghuvanshi as Next Drug Controller General of India

News 18  

Indian Pharmacopoeia Commission secretary-cum-scientific director Rajeev Singh Raghuvanshi has been recommended to be the next Drug Controller General of India. Dr Somani, Dr Raghuvanshi and Dr Jai Prakash, senior principal scientific officer at the Indian Pharmacopoeia Commission, appeared for interviews conducted by the UPSC last week. “The Union Public Service Commission on the basis of assessment of bio-data of the …

India Indian Upsc Drug Dcgi Raghuvanshi Rajeev Singh Raghuvanshi
Behind the Indian cough syrup that killed many in Gambia and Uzbekistan
1 year, 11 months ago

Behind the Indian cough syrup that killed many in Gambia and Uzbekistan

The Hindu  

Published : Jan 12, 2023 10:20 IST It was a scandal the Indian government was least prepared for. The Uzbek incident According to the Uzbekistan Health Ministry’s press note, a special working group it constituted began an inspection after children in Samarkhand who had consumed the syrup reported side effects. India’s Health Ministry explained that Maiden Pharmaceuticals had obtained an …

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Samples Not Contaminated, Meets Standards: Centre Slams WHO Over Premature Links Between Children Deaths in Gambia and India-made Syrups
2 years ago

Samples Not Contaminated, Meets Standards: Centre Slams WHO Over Premature Links Between Children Deaths in Gambia and India-made Syrups

News 18  

The World Health Organisation drew premature links between the deaths of children in Gambia and the four India-made cough syrups, India’s drug regulator DCGI has said in a strong statement slamming the WHO, reports Reuters. “Samples taken from Indian pharmaceutical company Maiden Pharma, whose products were linked to the deaths of children in Gambia, have been found to comply with …

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Indian-made cough syrups did not cause Gambia children deaths, DCGI informs WHO
2 years ago

Indian-made cough syrups did not cause Gambia children deaths, DCGI informs WHO

India TV News  

The Drugs Controller General of India has informed WHO that linking Indian-made cough syrups to deaths in Gambia was 'premature conclusion' which impacted the image of the country's pharmaceutical products across the globe. In the latest letter to Dr Rogerio Gaspar, Director at WHO, DCGI Dr V G Somani said a statement issued by the global health body in October …

India Deaths Indian Gambia Dcgi Somani Syrup
The Gambia children deaths | WHO drew premature link with India-made cough syrups, says drugs regulator
2 years ago

The Gambia children deaths | WHO drew premature link with India-made cough syrups, says drugs regulator

The Hindu  

The WHO drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe, India's drug regulator has told the global health body. In the latest letter to Dr. Rogerio Gaspar, Director at WHO, Drugs Controller General of India Dr. V. G. …

India Deaths Pharmaceutical Cdsco Gambia Dcgi Cough
Govt panel says information shared by WHO inadequate to determine reason for deaths linked to Gambia
2 years, 2 months ago

Govt panel says information shared by WHO inadequate to determine reason for deaths linked to Gambia

India TV News  

The committee set up by the government to examine reports potentially linking the death of 66 children in The Gambia to four made-in-India cough syrups has observed that the clinical information shared by the World Health Organization so far is inadequate to determine the aetiology. In an email response, Dr Somani on Saturday said the Union Ministry of Health has …

India Deaths Haryana Committee Received Cdsco Shared
Follow Prescribed Standards for Drug Testing, Govt Tells States After WHO Medicine Alert - News18
2 years, 2 months ago

Follow Prescribed Standards for Drug Testing, Govt Tells States After WHO Medicine Alert - News18

News 18  

Triggered by the World Health Organization’s alert linking made-in-India cough syrups to the deaths of children in Gambia, the government has directed all drug regulators to ensure prescribed standards to test the quality of drugs are followed, News18 has learnt. In a letter to drug regulators of state and Union Territories, the Drug Controller General of India has endorsed the …

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Haryana pharma company linked to Gambia deaths was blacklisted by Vietnam
2 years, 2 months ago

Haryana pharma company linked to Gambia deaths was blacklisted by Vietnam

Hindustan Times  

: Maiden Pharmaceutical Ltd, having its manufacturing unit in Haryana’s Sonepat district and under scanner after it was linked to the deaths of 66 children in Gambia, was one of the 46 Indian companies blacklisted by the Vietnam government in 2013. A probe has been initiated by India's drug regulator after WHO issued an alert saying cough syrups manufactured by …

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Health Matters: India Must Regulate Drug Regulatory Body First. Bribery Controversy Blessing in Disguise
2 years, 5 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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India's drugs regulator approves phase-3 trial of covid vaccine covovax
2 years, 9 months ago

India's drugs regulator approves phase-3 trial of covid vaccine covovax

India Today  

The Drugs Controller General of India granted permission on Wednesday for conducting the phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, official sources said. The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation had, on March 5, recommended permission for conducting the phase-3 clinical trial for Covovax as a booster dose …

India Covid Vaccine Booster Dcgi Covovax
COVID 19: Govt panel recommends permission for phase-3 trial of Covovax as booster dose in adults
2 years, 9 months ago

COVID 19: Govt panel recommends permission for phase-3 trial of Covovax as booster dose in adults

India TV News  

Highlights Govt has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax. An expert panel of India's central drug authority has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation …

India Trial Covid Singh Vaccine Permission Booster
Molnupiravir, oral anti-Covid medicine, set for launch in India; to cost Rs 649 per strip
2 years, 11 months ago

Molnupiravir, oral anti-Covid medicine, set for launch in India; to cost Rs 649 per strip

India TV News  

Molnupiravir, the world’s first and only oral antiviral to be approved by the US FDA, UK MHRA and Indian CDSCO for treatment of COVID-19, is set for a launch. Last week, the Drugs Controller General of India, based on the review of clinical data of molnupiravir, approved molnupiravir for treatment of adult patients with Covid-19, with SpO2 > 93% and …

India Launch Drug Dcgi Entod Pharmaceuticals Entod Molnupiravir
Govt allows export of 7 crore Covovax vaccine doses to Netherlands, Australia, New Zealand
2 years, 11 months ago

Govt allows export of 7 crore Covovax vaccine doses to Netherlands, Australia, New Zealand

India Today  

The Indian government has permitted the export of 7 crore doses of COVID-19 vaccine ‘Covovax’ produced by Serum Institute of India here to Netherlands, Australia and New Zealand, official sources said on Wednesday. Director, Government and Regulatory Affairs at Serum Institute of India, Prakash Kumar Singh had submitted an application to the Drugs Controller General of India, seeking no objection …

India Netherlands New Zealand Vaccine Doses Dcgi 7 Crore
Dr Reddy's Expected to Submit Sputnik V Light Trial Data to DCGI in November
3 years, 1 month ago

Dr Reddy's Expected to Submit Sputnik V Light Trial Data to DCGI in November

News 18  

Dr Reddy's Laboratories Ltd is expected to submit Phase 3 trials data of single dose Russian COVID-19 vaccine Sputnik Light to the Indian drug regulator next month, even as the city-based firm is getting ready to conduct trials of the jab in 2 to 18 year old children in two cohorts. Deepak Sapra CEO API and Services Dr. Reddy's said …

India Trial Trials Sec Dcgi Dose Sputnik
India's First mRNA-Based Covid Vaccine Gets DCGI Approval For Phase 2-3 Trials
3 years, 4 months ago

India's First mRNA-Based Covid Vaccine Gets DCGI Approval For Phase 2-3 Trials

ABP News  

New Delhi: India's first mRNA-based Covid-19 vaccine on Tuesday got the Drugs Controller General of India nod to move into Phase 2 and 3 trials. According to reports, the Centre informed that the vaccine developed by Gennova Biopharmaceuticals Ltd. was found to be safe, and was given go-ahead for Phase II/III trials. "After establishing the safety of our mRNA-based COVID-19 …

India Trial Covid Study Phase Vaccine Mrna
Proposal to study mixing of Covaxin, Covishield approved by DCGI
3 years, 4 months ago

Proposal to study mixing of Covaxin, Covishield approved by DCGI

India TV News  

The Drugs Controller General Of India, India's drug regulator, has approved a proposal for a study to be conducted on the mixing of two COVID-19 vaccines -- Covishield and Covaxin. The aim of the study will be to assess the feasibility on whether a person can be given two different vaccine shots -- one each of Covishield and Covaxin -- …

India Medical Research Study Vaccine Dcgi Research Icmr Covaxin
Moderna's Covid-19 vaccine gets emergency use nod from DCGI
3 years, 5 months ago

Moderna's Covid-19 vaccine gets emergency use nod from DCGI

India Today  

US vaccine manufacturing giant Moderna has secured restricted emergency use authorisation for its Covid-19 vaccine in India. Besides this, Indian drug manufacturer Cipla has been given permission to import Moderna's Covid-19 vaccine. "An application was received from Moderna through their Indian partner Cipla following which Moderna's Covid-19 vaccine has been granted restricted emergency use authorisation by the drug regulator. Besides …

India Indian Vaccines Cipla Developed Dcgi Import
Why WHO assessment of safety and efficacy is essential for Covaxin to get nod for global emergency use
3 years, 6 months ago

Why WHO assessment of safety and efficacy is essential for Covaxin to get nod for global emergency use

Firstpost  

WHO has said that a COVID-19 vaccine should at least show the efficacy of 50 percent in mandated trials and Covaxin clears this requirement with its latest Phase-3 results With 77.8 percent efficacy rate and at least over 2.5 crore doses administered so far, Covaxin is up for evaluation by WHO as India’s only indigenously created COVID-19 vaccine eyes an …

Health India Emergency Trials Vaccines Clinical Trials Covid
Bharat Biotech submits Covaxin's Phase III trial data to DCGI: Govt sources
3 years, 6 months ago

Bharat Biotech submits Covaxin's Phase III trial data to DCGI: Govt sources

India TV News  

The Hyderabad-based COVID vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to Drugs Controller General of India over the weekend, according to government sources. "We have received the data from the phase III trials," a senior government official confirmed. The phase III data of its vaccine have been questioned various times and that …

India Dcgi Covid Vaccine Bharat Biotech Iii Data
CSIR Gets DCGI Nod For Clinical Trial Of Colchicine On Covid Patients - All You Need To Know About The Drug
3 years, 6 months ago

CSIR Gets DCGI Nod For Clinical Trial Of Colchicine On Covid Patients - All You Need To Know About The Drug

ABP News  

New Delhi: The Council of Scientific and Industrial Research and Hyderabad’s Laxai Life Sciences Private Limited have been given the regulatory approval by the Drugs Controller General of India to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the colchicine drug in improvement of clinical outcomes during the treatment of Covid-19 patients. CSIR Director General …

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Covishield Producer SII Seeks DCGI Approval To Manufacture Sputnik V Covid Vaccine
3 years, 6 months ago

Covishield Producer SII Seeks DCGI Approval To Manufacture Sputnik V Covid Vaccine

ABP News  

Covid Vaccine Update: The Serum Insititute Of India which is manufacturing the Coronavirus vaccine Covishield has sought permission from the government to manufacture the Russian vaccine Sputnik V in India. "The Serum Institute of India put up an application to the Drugs Controller General of India on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India," a …

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