Cdsco

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

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