Page 3 - Cdsco

Pharmaceutical companies, CDSCO to discuss regulatory matters on Friday

It is expected that representatives for MSMEs pharma manufacturers may raise the issue of extension of Revised Schedule M implementation timelines

CDSCO flags 135 drugs for failing quality standards for December 2024

Most drugs found NSQ by central labs this month were produced in units located in cities such as Ahmedabad, Vadodara, Himachal Pradesh's Baddi, Puducherry, Roorkee and Haridwar

CDSCO to disallow import of pre-owned, refurbished med devices into India

Health Ministry to constitute expert committee, import suspended until policy framework is finalised

Medtech industry expects regulatory body to reclassify more medical devices

CDSCO to initiate workshops; industry says step will bring regulatory uniformity

Wockhardt rises 5% on getting CDSCO's approval for pneumonia curing drug

The Indian drug regulator, Central Drugs Standard Control Organization (CDSCO) has approved Miqnaf (nafithromycin) as a new treatment for the Community-Acquired Bacterial Pneumonia (CABP) in Adults

CDSCO, WB drugs body seize spurious drugs worth Rs 6.6 Cr in Kolkata

Anti-cancer, anti-diabetic drugs, labelled as manufactured in various countries, among those recovered without any supporting documents

111 drug samples tested in November found 'not of standard quality': CDSCO

Central Drugs Standard Control Organisation (CDSCO) has found 41 drug samples tested in the central drug laboratories in November as 'not of standard quality' (NSQ), official sources said. Besides, 70 drug samples tested by the state drugs testing laboratories have also been identified as NSQ in November, they said. Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. "The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market," an official said. Two drug samples were identified as spurious drugs in November. Out of the two samples, one was picked by Bihar Drugs Control Authority and the other by CDSCO, Ghaziabad, the sources said. The drugs were made by unauthorised and unknown manufacturers, using brand names of other companies. Action to identify NSQ and spurious medicines is ta

CDSCO flags 2 drugs as spurious, another 111 fail quality test in Nov '24

While the CDSCO alert has named the brands for which they found spurious samples, the alert, however, does not name the drugmakers

Cipla gets approval to market Afrezza insulin inhalation powder in India

Drug maker Cipla on Wednesday said it has received approval from the Central Drugs Standard Control Organisation for the distribution and marketing of Afrezza inhalation powder in India. Afrezza, a product created and manufactured by MannKind Corporation (MannKind) USA, is used to improve glycemic control in adult patients with diabetes mellitus. By bringing a game-changing, patient-centred solution to diabetes management in India, Cipla will make this drug accessible to all and empower millions to take control of their health with greater ease, the Mumbai-based company said in a statement. Afrezza is a rapid-acting insulin delivered through an inhaler compared to current insulins which are given as injections. Taken at the beginning of a meal, the medication dissolves rapidly upon oral inhalation into the lungs and delivers insulin quickly to the bloodstream. Afrezza starts working as early as 12 minutes and helps in reducing the rapid increase seen in sugar levels with meals. T

Painkillers, anti-infective drugs fail quality tests most in 2024: CDSCO

While the apex drug regulator does not mention the brand names, it flagged several formulations and drug combinations in its drug alerts

Drug regulator CDSCO flags 3 drugs as spurious, 56 not of standard quality

CDSCO made the revelation in its monthly update for October; drugs include those used to treat acid reflux, lower cholesterol and reduce risk of heart disease

Medicine regulator explores reducing dependence on animals for drug trials

Activists and organisations like Peta have been opposing animal testing practices, raising concerns over animal welfare and pushed for alternative methods

CDSCO flags 4 drugs as spurious and 48 as not of standard quality

The apex drug regulatory body also listed 48 drugs and formulations, manufactured by 40 companies, as not of standard quality (NSQ)

Wockhardt gets favourable recommendation from CDSCO for antibiotic for CABP

Drug firm Wockhardt on Friday said the national drug regulator has accorded a favourable recommendation for its novel antibiotic developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has provided a favourable recommendation for Miqnaf (nafithromycin), the drug firm said in a statement. The SEC recommendation is based on CDSCO's comprehensive review of the product dossier consisting of non-clinical, US/EU Phase 1, Global Phase 2 and India Phase 3 clinical studies conducted over the last 15 years, it added. A positive opinion from the SEC of CDSCO would pave the way for gaining DCGI's final approval for Miqnaf, the company stated. Miqnaf is the once-a-day 3-days-only treatment for CABP patients, including those caused by multi-drug resistant (MDR) bugs. CABP is the most common infection, leading to hospitalisation and death. Globally, 2.4 million annual dea

CDSCO plans to ask more brands to put QR codes on packaging to stop fakes

This follows CDSCO's move last year to strictly implement barcodes or QR codes on 300 top medicine brands such as Allegra, Calpol, and Dolo

How safe is the pill? Substandard drugs on a decline amid crackdown

The first of a two-part series focuses on how quality audits and regulatory actions on pharma units nationwide are showing results

After Torrent, Alkem refutes claims of its drugs failing CDSCO test

Company claims samples of Pan-D, Clavam 625 tested were spurious, not manufactured by it

Torrent Pharmaceuticals refutes claim of Shelcal 500 failing CDSCO test

Company claims sample tested was spurious and not manufactured by it

CDSCO flags substandard batches in over 50 commonly prescribed drugs

More than 50 widely prescribed medications, including treatments for high blood pressure, acid reflux, and erectile dysfunction, were identified as substandard in quality

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