Page 2 - Fda

Use power judiciously, not like sword to kill mosquito: Bombay HC warns FDA

Observing that the Maharashtra FDA is using a sword to kill a mosquito and "shoots first" before asking questions, the Bombay High Court on Tuesday asked the regulator to use its power judiciously, warning of imposing heavy costs as cases of its drastic actions have come to its notice. Hearing a petition filed by Cadila Pharmaceuticals challenging the FDA's action on select drugs, the high court directed the agency to grant the company a hearing before taking any drastic action. Following the remarks made by a bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, the FDA submitted that the regulator will revoke its orders against the petitioner, issue show-cause notices, and grant it a hearing before passing a reasoned order. Cadila Pharmaceuticals Ltd has challenged the FDA's decision to bar the sale and distribution of some of its medicines and seizure of stock worth Rs 2.45 crore across the state over branding similarities. Government pleader Neha Bhide

Maharashtra bans manufacture, sale of analogue paneer: What did FDA find?

The state FDA said that selling analogue paneer as genuine dairy paneer would mislead consumers and constitute an unfair trade practice under the food safety law

Bombay HC questions FDA's '98% clean' rating for Mantralaya canteen

The Maharashtra Food and Drug Administration (FDA) needs to be "fair, impartial and uniform" in its drive concerning hotels and eateries, including those in government and semi-government establishments, the Bombay High Court noted on Friday, questioning the agency's "98 per cent clean" certificate to the Mantralaya canteen. A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad ordered a team of four lawyers to immediately visit and inspect the Mantralaya canteen and report to the court in the afternoon on the situation there. Within hours of the directive, the FDA, accompanied by lawyers, inspected the canteen at the state secretariat to check for hygiene and food safety standards. Earlier in the day, the FDA submitted to the court a chart detailing all eateries and canteens, including the three on the high court premises and at Mantralaya, as well as private clubs across the city. According to the chart, the Mantralaya canteen received a 98 per cent cleanliness

Maharashtra FDA enforces junk food ban within 50 metres of schools

Maharashtra FDA has banned the sale of processed and packaged foods and drinks high in fat, sugar and salt within 50 metres of school compounds, and the order will be implemented strictly, FDA commissioner Tukaram Mundhe said on Wednesday. He said every school kitchen operator and food supplier to schools should have licenses under food safety regulations. He said the sale, advertisement and free distribution of high-fat, salt and sugar (HFSS) food items are prohibited in and around all schools in the state as part of efforts to promote healthy eating habits among children. "Within school premises and up to 50 metres from the school compound, the sale, advertisement and free distribution of high fat, salt and sugar (HFSS) food items is completely banned by the FDA. It will be implemented strictly," Mundhe told reporters here. He said the state government had issued a compliance order on July 27 to enforce food safety and nutritional standards across educational institutions, adding

Maharashtra FDA chief widens crackdown on food adulteration, fake drugs

A civil servant, who has been reportedly been transferred over 25 times in his career, Mundhe is regarded as unyielding administrator whose frequent moves reflect his insistence on strict enforcement

Pune tops Maharashtra in complaints over unhygienic food, says FDA

Pune district has reported the highest number of complaints about unhygienic food in Maharashtra since the state Food and Drug Administration launched a complaint-reporting portal, FDA Commissioner Tukaram Mundhe has said. The senior IAS officer was in the city on Saturday to attend a food safety conference organised by the Mahratta Chamber of Commerce, Industries and Agriculture. Speaking to reporters, he said the FDA recently launched the portal "complaints.mahafda.in" to allow people to register their complaints concerning food items. "Thousands of complaints poured in after the portal went live and 10 lakh hits were recorded within 24 hours," he said. Asked about the distribution of complaints across the state, he said, "The highest number of complaints has been registered in Pune district, and most of them concern unhygienic food." The new system will bring in accountability and transparency, the official said. The FDA joint commissioner of the region concerned will take ...

FDA suspends licence of Mumbai's famed Parsi Dairy Farm over hygiene issues

The Maharashtra Food and Drug Administration (FDA) has suspended the food business licence of Mumbai-based Parsi Dairy Farm Pvt Ltd after finding serious food safety and hygiene violations, officials said on Thursday. The crackdown on the popular chain was part of a statewide enforcement drive in which food products worth more than Rs 1.90 crore were seized, they added. Inspections at Parsi Dairy Farm Pvt Ltd's Princess Street unit in south Mumbai revealed multiple violations of Food Safety and Standards Act and related regulations, prompting the immediate suspension of its FSSAI licence, the FDA said in a statement. Inspectors found unhygienic conditions, including a damaged raw milk reception dock, cracks in storage and production areas, improper storage of raw materials and finished products, heavy infestation of flies, broken flooring and drainage and absence of an effluent treatment plant, it said. The FDA team also found incomplete medical records of food handlers, inadequate

FDA suspends food business licences of 3 Mumbai restaurants: Here's why

The Maharashtra FDA has suspended the food business licences of Shalimar Hospitality, Noor Mohammadi Hotel and Rehmania Restaurant after inspections found multiple food safety and hygiene violation

US recalls 2.5 mn bottles of India-made eye drops after contamination scare

The US Food and Drug Administration (FDA) said the recall was started because of the potential presence of a foreign substance in the eye drops

Glenmark launches generic schizophrenia, bipolar disorder drug in US

Glenmark Pharmaceuticals on Monday announced the launch of the generic version of Olanzapine injection, indicated for treatment of schizophrenia and bipolar disorder, in the US. The company's arm Glenmark Pharmaceuticals Inc, USA has launched Olanzapine for injection of strength 10 mg/vial, single-dose vial, Glenmark said in a regulatory filing. The company's Olanzapine for injection is bioequivalent and therapeutically equivalent to the reference listed drug, Zyprexa intramuscular injection 10 mg/vial, of Cheplapharm Registration GmbH, it added. "The launch of Olanzapine for Injection underscores our strategic focus on growing a robust injectables portfolio and strengthening our presence within the institutional channel," Glenmark President & Business Head, North America, Marc Kikuchi said. Citing IQVIA sales data for the 12-month period ended May 2026, Glenmark said the Zyprexa intramuscular injection market achieved annual sales of approximately USD 25.4 million.

Zaynich antibiotic: How Wockhardt created India's first FDA-approved drug | Pharma Industry

For decades, India excelled at making affordable generic medicines. But creating a brand-new drug from scratch remained a rare achievement. Now, Wockhardt has made history with Zaynich

Maha FDA: Hospitals can't force patients to buy drugs from own pharmacies

The state regulator has directed hospitals and doctors to provide prescriptions directly to patients and allow them to buy medicines from any licensed pharmacy

Wockhardt eyes $1.5 bn peak sales from Zaynich, targets US launch by yr-end

Novel antibiotic to be launched in India around the same time; company to commercialise product on its own in US

US FDA flags data integrity, maintenance lapses at Dabur India plant

Dabur ​is one of India's oldest and largest consumer goods companies, describing itself ‌as one of the world's largest suppliers of Ayurvedic products with a legacy of over 140 years

Zydus eyes Q4 FY27 US launch for liver disease drug after FDA review

The US FDA has granted priority review to Saroglitazar, Zydus Lifesciences' drug for treating Primary Biliary Cholangitis

Eli Lilly backs Haryana FDA action on counterfeit Mounjaro seizures

Pharma major says seized fake Mounjaro in Gurugram did not originate from its supply chain, urges vigilance and purchase only through authorised channels

Orbicular Pharma gets US FDA nod for generic Ozempic with Apotex

Orbicular Pharma and Apotex secure tentative US FDA approval for generic Ozempic, marking entry into fast-growing semaglutide market pending patent clearance

Cipla's US unit recalls 400+ cartons of generic anti-cancer drug: USFDA

A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration (USFDA). Warren (New Jersey)-based Cipla USA, Inc is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said in its latest Enforcement Report. The company is recalling the affected lot (271 and 164 cartons) due to "failed tablet/capsule specifications", it stated. Cipla USA, Inc initiated the Class III voluntary recall on February 18 this year. According to the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". Nilotinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. India has the highest number of USFDA-compliant pharmaceutical plants outside of the ...

FDA to act against companies selling 'illegal copycat drugs', chief says

Makary's comments came after online telehealth company Hims and Hers Health began offering a much cheaper $49 compounded version of Novo Nordisk's new Wegovy weight-loss pill

Maharashtra FDA cancels 13 licences, suspends 32 medical stores in Nanded

The Maharashtra Food and Drug Administration (FDA) has cancelled the licences of 13 medical stores and suspended those of 32 in Nanded district over alleged sale of intoxicant tablets, officials have said. As part of a drive, the FDA had issued show-cause notices to 48 medical stores for selling intoxicant tablets without a doctor's prescription and for violating the Drugs and Cosmetics Act, Assistant Commissioner (Drugs) AT Rathod said in a release on Wednesday. After the explanations submitted were found unsatisfactory, the licences of 32 medical stores were suspended, while the licences of 13 stores were permanently cancelled. Action has been proposed against the remaining three medical stores, it said. In some cases, the FDA said, the medical stores have secured stay orders at the government level, and proceedings against them are currently pending before higher authorities.