Central Drugs Standard Control Organization (CDSCO): News
India approves Mounjaro KwikPen for diabetes and obesity treatment
Eli Lilly has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO) for its diabetes and weight-loss drug, Mounjaro.
AstraZeneca can now sell its cancer drug in India
AstraZeneca Pharma India Ltd has received the nod from the Central Drugs Standard Control Organisation (CDSCO) to import and sell a cancer treatment drug called Durvalumab.
Mpox update: Centre's advisory after India reports clade 1b case
The Union Health Ministry has issued a nationwide advisory following the detection of India's first Mpox clade 1b case.
Uzbekistan cough syrup deaths: India allows company to reopen factory
The Uttar Pradesh government has allowed Marion Biotech, which manufactured the cough syrup responsible for the deaths of 65 kids in Uzbekistan last year, to restart most production, Reuters reported.
Toxic levels of chemicals found in Indian-manufactured syrups again: Report
The Central Drugs Standard Control Organization (CDSCO) has claimed that the Gujarat Food and Drug Control Administration (FDCA) found toxic levels of ethylene glycol and diethylene glycol in batches of cough and allergic rhinitis syrups manufactured by Norris Medicines.
Indian company used toxic industrial chemical in syrup: Report
The India-made cough syrups linked to at least 19 deaths in Uzbekistan contained a toxic industrial-grade ingredient rather than the legitimate pharmaceutical version, Reuters reported.
Centre refutes reports on side-effects of COVID-19 vaccines
The Union Health Ministry on Tuesday rejected reports claiming that the Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) had admitted to numerous side effects of COVID-19 vaccines.
COVID-19: Centre approves Bharat Biotech's nasal vaccine as booster dose
Union Health Minister Mansukh Mandaviya informed on Friday that the Centre has approved Bharat Biotech's nasal vaccine to be used as a heterologous booster.
Haryana government halts cough syrup production linked to Gambia deaths
The Haryana government suspended cough syrup production at a Maiden Pharmaceuticals facility on Wednesday, a week after the World Health Organization (WHO) warned that the drug may be related to the deaths of scores of children in the Gambia.
66 Gambia deaths: Centre probes Indian company's 4 cough syrups
After the death of 66 children in the Gambia, the World Health Organization (WHO) issued an alert against using four fever, cold, and cough syrups manufactured by Maiden Pharmaceuticals Limited — an Indian pharmaceuticals company based in Haryana.
Expert panel recommends emergency use authorization for Zydus's three-dose vaccine
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting an emergency use authorization (EUA) to ZyCoV-D, the three-dose COVID-19 vaccine developed by Zydus Cadila, on Friday.
J&J withdraws vaccine approval request in India, CDSCO says
Johnson & Johnson has withdrawn its proposal seeking an accelerated approval of its COVID-19 vaccine, Janssen, in India, the country's drug regulator said.
Government expert panel recommends conducting trials on mixing Covishield, COVAXIN
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has given its go-ahead for conducting clinical trials involving the mixing and matching of Covishield and COVAXIN vaccine doses.
Expert panel says no to Covovax's children trials in India
A Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) has denied permission to Pune-based Serum Institute of India (SII) for conducting clinical trials of its second COVID-19 vaccine, Covovax, in children.
COVAXIN phase 2/3 trials for 2-18-year-olds recommended by expert panel
In a bid to extend the country's vaccination drive to include people below 18 years, an expert panel on Tuesday recommended Hyderabad-based Bharat Biotech's COVID-19 vaccine COVAXIN for phase 2/3 clinical trials on children and adolescents aged two to 18 years.
Foreign COVID-19 vaccines: Decision on EUA applications within three days
India's drug regulator will make a decision on applications seeking approval for restricted emergency use of foreign-produced vaccines within three working days from the date of submission, the government said on Thursday.
Panel recommends permission for Phase I Intranasal COVID-19 vaccine trial
An expert panel, Central Drugs Standard Control Organisation, (CDSCO) on Tuesday recommended granting permission for conducting the Phase I clinical trial of an intranasal vaccine against COVID-19 developed by Bharat Biotech, official sources said.
Coronavirus vaccine: Bharat Biotech's COVAXIN gets expert panel nod
A government-appointed panel on Saturday recommended emergency-use authorization (EUA) to the COVID-19 vaccine developed by Hyderabad-based Bharat Biotech.
India set to start COVID-19 vaccination; panel approves Oxford vaccine
In a development that will soothe the coronavirus-battered nation, the Central Drugs Standard Control Organization (CDSCO) panel on Friday gave approval to the vaccine developed by the University of Oxford and British-pharma giant AstraZeneca.
UK's approval to Oxford-AstraZeneca vaccine paves way for India
The United Kingdom on Wednesday approved the vaccine developed by Oxford University and the British-Swedish pharmaceutical company AstraZeneca, giving the vaccine an endorsement that will likely be considered by Indian drug regulators.
Trial will continue: Centre on SII vaccine's "adverse reaction" claims
With the coronavirus vaccine trials being conducted by Serum Institute of India (SII) being shrouded in controversy after a participant complained of an "adverse reaction," the Centre on Tuesday said there's no need to stop the process.
India rejects large scale trial of Russia's COVID-19 vaccine
India's drug regulator has refused to allow a large scale clinical trial of Russia's Sputnik V COVID-19 vaccine.
Dr. Reddy's bringing coronavirus vaccine to India by 2020-end
In a major development, Hyderabad-based pharma company Dr. Reddy's Laboratories has partnered with the Russian Direct Investment Fund (RDIF) to source their Sputnik V COVID-19 vaccine for India.
Coronavirus: How soon could Russian vaccine be available in India?
On Tuesday, Russia announced what it claims is the first COVID-19 vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow.
Remdesivir reportedly approved for COVID-19 treatment in India
Remdesivir has been approved by India's top drug regulator for "restricted emergency use" on COVID-19-infected adults and children.
#GoodNews: Pune's Mylab approved to make COVID-19 test kits
In a major development, Pune-based molecular diagnostics company Mylab Discovery Solutions has been given the go-ahead to develop testing kits for the novel coronavirus disease (COVID-19).
SC seeks Center's response on faulty hip implants by J&J
The Supreme Court yesterday sought the Center's response on a plea alleging that "faulty" and "deadly" hip implants, made by US-based pharma major Johnson & Johnson (J&J), have been fitted into the bodies of 14,525 Indian patients, termed as "medical negligence" by an expert committee.
Health Ministry to rename drug regulator CDSCO; invites suggestions
The Union Health Ministry has invited suggestions for renaming the country's drug regulator CDSCO in line with its expanded roles.
Government plans to make companies responsible for drug regulation violations
To ensure the quality of drugs, Health Ministry is planning to make companies, which market and promote medicines, responsible for any violation of drug regulations like manufacturers.
Health Ministry bans sale of 14 steroid-creams sans doctor's prescription
Health Ministry has banned over-the-counter (OTC) sale of 14 steroid-based creams and ointments by bringing them under the Schedule H of the Drugs and Cosmetics Rules, 1945.
Bengaluru Lake Frothing: Centre seeks CPCB's response over phosphorus pollution
Bengaluru's Bellandur Lake frothing has turned the Centre's attention to high phosphorus content in laundry detergents, bars, and industrial cleaners.