Page 4 - Cdsco

CDSCO flags over 50 drugs of various companies as 'not of standard quality'

The country's central drug regulatory authority has listed samples of more than 50 drugs, including paracetamol, Pan D, calcium and vitamin D3 supplements, and anti-diabetes pills, as "not of standard quality" in its latest report. The batches of medicines flagged by the Central Drugs Standard Control Organisation (CDSCO) in its drug alert for August are of companies such as Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, Priya Pharmaceuticals and Scott-Edil Pharmacia Ltd. The CDSCO's drug alert for August included samples from batches of medications such as Shelcal, Vitamin B Complex with Vitamin C Softgels, vitamin C and D3 tablets and Ciprofloxacin tablets. High blood pressure medications Telmisartan and Atropine Sulphate and antibiotics such as Amoxicillin And Potassium Clavulanate tablets have also been categorised as not of "not of standard quality". While batches of some drugs

Regulator CDSCO suspends Entod Pharmaceuticals nod to make, sell eye drops

Action taken over company's claim that the eye drop use will replace reading glasses

34 more fixed-dose combination under scanner, says CDSCO official

The list of FDCs banned includes antibiotics, anti-allergics, painkillers, multivitamins, and combination doses for fever and hypertension, among others

Over 100 Indian cough syrup samples fail quality tests, linked to deaths

Some of these collected samples contained the same toxins found in cough syrups linked to the deaths of children in Gambia, Uzbekistan, and Cameroon

Pharma groups criticise plan to shift nutraceuticals under drug authority

Pharmaceutical industry is urging government to halt the transfer of nutraceutical oversight from FSSAI to the drug regulatory authority, citing potential market impact

CDSCO cracks whip on drug manufacturing units over quality lapses

Shuts down 36% of facilities for failing to meet quality standards

CDSCO says 52 medicines, including Paracetamol, failed quality check in May

The widespread nature of the issue stretches across different regions of the country, including Himachal Pradesh, Hyderabad, Waghodia, Vadodara, Andhra Pradesh, and Indore

Medical device bodies welcome CDSCO order on self-reporting adverse effects

The drug regulator stated that medical device manufacturers need to take appropriate action for timely reporting of adverse events related to medical devices to MvPI

Medical device companies get a three-month extension for licences

The step comes after several medical device associations and stakeholders had sent representations to the drug regulator, asking for an extension to adhere to the new licensing regulations

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