Page 5 - Cdsco

Govt launches Nandi portal for granting NOC for veterinary drugs, vaccines

Union Minister Parshottam Rupala on Monday launched a Nandi portal to timely process applications and grant non-objection certification (NOC) for veterinary drugs and vaccines. The regulation of the import, manufacturing and marketing of veterinary drugs and vaccines comes under the purview of the Central Drug Standard Control Organization (CDSCO) under the Ministry of Health. However, permission for the import/manufacture of veterinary drugs, vaccines and biological are granted in consultation with the Ministry of Fisheries, Animal Husbandry and Dairying. The present system is manual. "The Health Ministry gives final approval of drugs and vaccines. In the case of veterinary products, it cannot give without the NOC from us. Since granting of NOC was manual, delay/obstacle from our ministry was felt. So, the portal NANDI (NOC Approval for New Drug and Inoculation System) has been launched," the Fisheries, Animal Husbandry and Dairying Minister said after the launch. This is a timely

AstraZeneca receives CDSCO's approval for cancer drug Tremelimumab

AstraZeneca Pharma India on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its cancer drug Tremelimumab Concentrate to be administered intravenously. The approval for Tremelimumab in combination with Durvalumab is based on results from Phase III HIMALAYA clinical trial and is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC), the drug firm said. The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia including India, it added. The approval paves the way for the launch of Tremelimumab solution of 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single-dose vials in India for the specified indication, AstraZeneca Pharma said. "This approval is in line with our ambition of transforming patient outcomes and not leaving any patient behind. We have a breadth of scientific platforms to attack cancer while exploring the po

India working on single-window portal for drug regulation processes

System will bring together stakeholders like manufacturers, distributors, state-run agencies to ensure quality

Chintan shivir on drugs to diagnose and treat issues of trust, quality

Proposals to be discussed at Hyderabad conclave include having a centralised drug registration system under CDSCO

Former Ranbaxy, DRL exec Rajeev Raghuvanshi appointed as new DCGI

Appointment comes at a time when India's pharma regulatory landscape is under the scanner

Regulators halt eye products' production at Global Pharma Healthcare site

Firm under US FDA scanner for bacterial contamination of its eye drops

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CDSCO probes Indian eyedrops after US FDA flags contamination risk

Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears

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