Fdc Medicines

Government bans 16 fixed drug combinations over health safety concerns

Health Ministry prohibits 16 fixed drug combinations, including antibiotic and cosmetic formulations, after an expert review found they lacked therapeutic justification and posed potential health risk

Centre bans sale, manufacture of 16 FDC drugs over public health concerns

The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved. The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The decision follows a review of FDCs undertaken in compliance with the Supreme Court's directions. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. "The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall sta

Glenmark, FDC recall products from US market on manufacturing issues: USFDA

Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). In its latest Enforcement Report, the US health regulator said a US-based subsidiary of Mumbai-headquartered Glenmark Pharmaceuticals is recalling a certain number of a generic hypertension medication in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling Carvediol tablets in strengths of 25 mg and 12.5 mg in the US, the US health regulator stated. The company is recalling the product as "N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit". The company initiated the Class II recall on January 22 this year. USFDA said FDC Ltd is recalling 1,18,104 bottles of a medication for the treatment of glaucoma. The drug firm is recalling the affected lot of Timolol Maleate ophthalmic solution USP produced at its Aurangabad-based plant, it added

India's psychotropic drug market flooded with unapproved FDCs: Study

Over 60 per cent of the fixed-dose combination (FDC) drugs used for treating mental health disorders in India are 'unapproved' and lack proven therapeutic value, the study found

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

Top headlines: Car makers eye pre-Covid profits, Air India's market share

Optical fibre cable (OFC) manufacturers are bracing to meet a multifold increase in fiberisation, aggressively tap global markets to power 5G services, and cope with demand from fibre-to-the home

Centre looking to phase out codeine-based cough syrups, select FDCs

The industry is divided on the issue of phasing out codeine-based cough syrups, which are used by many as intoxicants

DTAB to review 19 fixed-dose combinations drugs, codeine formulations today

CDSCO aims to phase out these combinations and codeine-based drugs in a phased manner

Glenmark Pharma launches first FDC drug Indamet for asthma patients

Glenmark Pharmaceuticals on Thursday said it has launched a novel fixed-dose combination (FDC) drug in the country for patients with uncontrolled asthma. The Mumbai-based drug major has launched - Indacaterol + Mometasone FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg and 320 mcg to be taken once daily. "Respiratory is a key focus area for Glenmark, and the company leads from the front in providing access to the latest treatment options to patients. "We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," Glenmark Pharmaceuticals Group Vice President & Head (India Formulations) Alok Malik said in a statement. The drug maker is the first company in India to market the FDC of .

Delhi HC quashes ban on anti-inflammatory drug Ace Proxyvon, faults Centre

In September last year, the government had banned around 328 Fixed Dose Combination (FDC) drugs, citing lack of therapeutic justification

Supreme Court refers 349 FDC medicines to Drug Advisory Board for relook

The apex court set aside the order of the Delhi High Court which had quashed the Centre's decision to ban these drugs on the ground that requisite procedure prescribed in the Drugs and Cosmetics Act,