Page 2 - Cdsco

Sanofi India introduces diabetes drug 'Soliqua' at Rs 1,850 per pen

Sanofi reported that in India, over 100 million individuals are grappling with type 2 diabetes and its associated complexities

Entod Pharma receives CDSCO approval to commercialise presbyopia treatment

The company had completed the development of these eye drops in late 2022, after which it was subjected to clinical testing in India

Eyestem gets CDSCO nod to conduct human trials to treat retinal vision loss

Dry age-related macular degeneration (AMD) causes degeneration of retinal cells resulting in vision loss in people over the age of 60

Several pharma cos step up corrective action plans after crackdown by govt

The orders in the state have now been revoked, with the companies undergoing corrective and preventive action (CAPA) processes

Cipla receives approval from drug regulator CDSCO for UTI drug

Plazomicin is a new intravenous (IV) aminoglycoside that has demonstrated efficacy and safety in clinical trials compared to meropenem (antibacterial agent)

Govt panel set to review if nutraceuticals should be brought under CDSCO

The government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator CDSCO instead of the food regulator FSSAI to address regulatory challenges and promote consumer safety Presently, the Food Safety and Standards Authority of India (FSSAI) regulates the usage of health supplements and nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022. This regulation covers food items that are specially processed or formulated for specific nutritional or dietary purposes, official sources said. Nutraceuticals are products derived from food sources that are believed to provide extra health benefits besides the basic nutritional value found in foods The sources said that the challenges in uniform implementation and enforcement, interchangeable usage of the same nutrient/ingredient at ...

Samples of 59 drugs declared as 'not of standard quality', says CDSCO

Samples of 59 drugs, including those of reputed companies, were declared as "not of standard quality" in October, according to a Central Drugs Standard Control Organisation (CDSCO) alert. The CDSCO in its alert, which was issued recently, said that 1,105 samples were tested. Of the total, 61, which include two samples of unlabelled vials with white seal purported to contain Tigecycline 50 mg and two samples of phenolic disinfecting multi-purpose surface cleaner-cum-deodoriser (Lytner), were found to be "not of standard quality", it said. The count comes to 59 as samples of two drugs were repeated. The drug samples were tested at various statutory laboratories authorised by the CDSCO. The other samples termed "not of standard quality" include those of Cefixime Oral Suspension IP, Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets (GAMPCLAV-625 LB Tablets), Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg), Diclofenac So

Govt mulling guidelines for OTC medicines; move to reduce burden on doctors

Industry players present at the event highlighted that the OTC market offers a major business opportunity, but it needs transparent and clear regulations

CDSCO gives 6-month extension to medical device manufacturers for imports

Under the new regulation, medical devices under' class C' and 'class D' cannot be sold without a manufacturing licence after October 1

Drug regulator CDSCO finds syrups made by Norris Medicines toxic: Report

The drug regulator for Gujarat state, where Norris is based, told Reuters that its factory had been closed

Health ministry plans drug licensing changes to ensure drug safety

Proposals aim to standardise drug manufacturing practices after a few Indian medicines were flagged as 'substandard' by the WHO

CDSCO orders Riemann Labs to stop making cough syrup linked to deaths

The Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controllers of Madhya Pradesh has directed pharma firm Riemann Labs to halt manufacturing of its cough syrup that was linked to deaths of children in Cameroon. "In the case of Cameroon, a joint inspection was conducted by CDSCO, sub-zone Indore with SLA, Madhya Pradesh at M/s Riemann Labs, Indore and based on the findings the State Drugs Controller MP has directed the firm to stop the manufacturing activities," Minister of State (MoS) for Health Bharati Pravin Pawar said in a written reply in Rajya Sabha on Tuesday. The World Health Organization (WHO) had on July 19 issued an alert regarding cough syrup supplied in Cameroon stating an analysis has found that the product contained "unacceptable amounts of diethylene glycol as contaminants." The makers of Naturcold listed paracetamol, phenylephrine hydrochloride, and chlorpheniramine maleate as active ingredients, and a combination of these three i

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