Page 3 - Cdsco

Chennai-based firm's eye drops contaminated, says US FDA report

The US FDA said that using contaminated artificial tears increases risk of eye infections that could result in blindness or death

Cough syrup deaths: Centre, UP team inspect pharma firm's Noida unit

Cough syrup maker linked to Uzbekistan deaths halts production; samples of Dok-1 Max sent for analysis

CDSCO, states begin joint checks of drug-making units across India

Objective of drug regulation is to ensure safety, efficacy, and quality of drugs

CDSCO approved recombinant nasal Covid vaccine on Sep 5: Govt in RS

The Central Drugs Standard Control Organisation (CDSCO) approved the recombinant nasal COVID-19 vaccine on September 5 this year for those aged 18 years and above, Minister of State for Health Bharati Pravin Pawar told the Rajya Sabha on Tuesday. In a written reply, Pawar said the vaccine is to be given in two doses of 0.5 ml each in a gap of 28 days. It is to be administered intranasally. Under the Vaccine Maitri Programme, India has supplied COVID-19 vaccine to more than 90 countries in the form of grant, commercial export or through the global vaccine alliance COVAX, Pawar said.

Role of Maiden Pharma cough syrups in Gambia kids' deaths not confirmed

Indian Health ministry sources say the Haryana-based drug maker is currently being probed for lapses in good manufacturing practices

Several states initiate action over contaminated cough syrup controversy

According to the media reports, Karnataka has directed all drugmakers to test samples of glycerine and propylene glycol and submit a report within seven days.

Drug regulator halts production at Maiden Pharma's Sonipat unit

Centre forms panel to analyse causal relation between deaths and cough syrups

Preliminary report suggests lapse in manufacturing process at Maiden Pharma

The firm has been in news for supplying contaminated cough syrups to Gambia, which is linked to the deaths of 66 children due to the presence of contaminants

CDSCO takes up investigation on WHO's complaint for India-made cough syrups

After the World Health Organization issued an alert on four India-made cough and cold syrups used for paediatric groups, the Central Drugs Standard Control Organisation has taken up an urgent probe

DTAB to review 19 fixed-dose combinations drugs, codeine formulations today

CDSCO aims to phase out these combinations and codeine-based drugs in a phased manner

Existing infra for testing medical devices inadequate: Parliamentary panel

The report presented in the Parliament by a standing committee stated that along with more testing labs, the country needs a robust IT-enabled and feedback-driven post-sales surveillance system

Biocon arm Syngene ends contract with Bioinnovat Research over graft case

Guljit Sethi of Bioinnovat was named in CBI FIR on a bribery case involving CDSCO official and Biocon Biologics executive

India's first mRNA Covid vaccine will be priced competitively, says company

Gemcovac does not require sub-zero temperatures for storage and transport, unlike two other international doses

CBI arrests Jt Drug Controller, Biocon Biologics execs over fishy approvals

All five apprehended will be presented in court on Tuesday afternoon, agency to seek police custody

SEC recommendation in accordance with guidelines: Biocon Biologics

The company said its product approvals are backed by science and clinical data

Virtual audits will not replace physical inspection, says USFDA

Surprise audits of manufacturing sites too are on the cards

Wockhardt gets CDSCO approval to export Russian Covid vaccine Sputnik

The approval is for the export of up to 8 crore doses of Sputnik Light and up to 2 crore doses of Sputnik V Component I vaccines, Wockhardt Ltd said in a regulatory filing

Centre forms 8-member panel for new Drugs, Cosmetics, Medical Devices Act

Committee will frame draft Bill and submit it by November 30

Cipla launches Roche's Covid antibody cocktail in India for Rs 60k per dose

The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate Covid-19 in adults and pediatric patients

Natco gets approval for emergency use of Baricitinib for Covid-19 treatment

Natco Pharma has received emergency use approval for Baricitinib tablets, for the treatment of Covid-19 positive patients, from the Central Drugs Standard Control Organization (CDSCO) in India