Cdsco

Cough syrup deaths: Old regulatory failures resurface as CDSCO calls for ‘strict quality control’

The directive is similar to the one issued after India-made cough syrups were blamed for deaths of children in Gambia and Uzbekistan even as Coldrif toll climbs to 22 after two more children die

Not in the bin, down the drain: Why India’s drug regulator wants you to flush these 17 expired medicines immediately

These drugs, the regulator warns, are especially dangerous if used by someone other than the person for whom they were prescribed.

Wockhardt shares rally 5% after Indian drug regulator approves Pneumonia antibiotic

Central Drugs Standard Control Organization (CDSCO) approved antibiotic Nafithromycin, sold under Miqnaf brand, as a new treatment for community-acquired bacterial Pneumonia (CABP) in adults.

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

In addition, 70 drug samples tested by state drugs testing laboratories have also been identified as NSQ in November, they added. Identification of drug samples as NSQ is based on failure in one or more specified quality parameters.

Non-genuine, spurious: Torrent Pharma's Shelcal 500 that failed CDSCO test not made by company

Torrent said it has implemented QR codes displaying the batch manufacturing details to verify authenticity, which was found lacking in the seized samples of Shelcal. Torrent has already submitted the response and assessment report to CDSCO.

Sanofi gets CDSCO nod for Beyfortus India

Beyfortus is used for the prevention of Respiratory Syncytial Virus (RSV) and Lower Respiratory Tract Disease (LRTD) in newborns and infants.

Drugs controller orders immediate withdrawal of unapproved anti-bacterial drug

The drug can be used to treat bacterial diseases such as pneumonia, urinary tract infections, intra-abdominal infections, gynaecological infections, skin infections, meningitis, and sepsis

What are nutraceuticals and why is government planning more regulations around them?

Though nutraceuticals are consumed widely, there is limited evidence of their health benefits in well-nourished adults. The government is planning tighter regulations on their quality, pricing and marketing aspects

CDSCO inspections highlight major problems in pharmaceutical units and testing labs

Inadequate documentation practices, a lack of standardised processes, gaps in analytical validations, a lack of self-assessment protocols, a failure to conduct thorough quality failure investigations, and a lack of oversight in conducting internal product quality reviews are among the major issues that were brought to light during the inspections.

Samples of 59 drugs declared as 'not of standard quality': CDSCO

The drug samples were tested at various statutory laboratories authorised by the CDSCO.

Regulator begins major enforcement drive on poor drug-making practices

These enforcement actions are a part of risk-based inspection to ensure Good Manufacturing Practices (GMP) norms are met

How Sun Pharma’s complaint helped authorities seize fake medicines worth Rs 2 cr

Call detail records (CDR) of one of the accused led the investigation team to a warehouse where the fake medicines were stored. The seizure found fakes of products of all top pharma companies. More raids are being planned.

AstraZeneca gets CDSCO nod for drug to treat biliary tract cancer

BTC is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).

Cystic fibrosis patients pitch for life-saving drugs that are currently unavailable in India

Cystic fibrosis is life-threatening as it damages both the lungs and the digestive system, with those undiagnosed often dying in infancy.

Is uniform implementation of drug approval system a possibility in India?

In 2003, the RA Mashelkar Committee said that a strong, well-equipped, empowered, independent and professionally-managed CDSCO, which could be given the status of Central Drug Administration, reporting directly to the Ministry of Health would be the most appropriate solution.

Merge state, central drug regulators for better standards: Bharat Biotech chairman

In the past few months, there have been repeated instances of foreign drug regulators raising the red flag against medicines manufactured by Indian pharmaceutical firms

"Ill-informed and erroneous': Govt refutes reports claiming admission of COVID vaccine side-effects

The government said the ICMR had simply provided a list of advantages and disadvantages of COVID-19 vaccines through reputed websites of WHO, CDC and the ministry where compiled global evidence on various vaccines is available.

What can the inspection of select drugmaking units hope to achieve?

Experts point out that laxity on the part of regulators has resulted in substandard and adulterated drugs hitting markets in India and other countries with weak regulatory oversight.

Exclusive | Uzbekistan Cough Syrup Case: Drugs sold by Marion Biotech in India under scanner

Drug authorities have asked the drug maker for an undertaking clarifying whether the Doc-1 Max syrup has been supplied in any part of India

Uzbekistan claims cough syrup made in Noida responsible for death of 18 kids; CDSCO calls for causality assessment report

“We have taken note of the matter and have asked for the causality assessment report of the death of children from the authorities of Uzbekistan,” a top CDSCO official told Moneycontrol.