The US Food and Drug Administration's (USFDA)'s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars - lower-priced, near-replicas of complex biologic medicines - could significantly benefit Indian biotech companies.
Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that's been locked up. The non-descript two-room building is a manufacturing unit of Sresan Pharmaceuticals, the pharma company made its Coldriff cough syrup that has allegedly killed 25 children in Madhya Pradesh.
Amid controversy over USPresident Donald Trump's comments linking the use of Tylenol and other related paracetamol products by pregnant women to autism in children, experts and industry executives say that since India's export of the drug to the US is less, it will hardly affect the country's pharma exports to America.
The Maharashtra Food and Drugs Administration (FDA) has suspended the license of a caterer that operates the canteen at the MLA hostel in Mumbai, after a Shiv Sena legislator assaulted a staffer for allegedly serving stale food.
Concerns over weakening demand for Indian pharmaceutical (pharma) drugs in the US - their largest export market - have weighed heavily on investor sentiment this year. While the Nifty 50 has gained 6.02 per cent year - to - date (as on September 15), the Nifty Pharma index has declined 5.18 per cent, National Stock Exchange data shows.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
In contrast to Trump's strong warnings, the FDA's current position remains more measured. In a recent letter to physicians, the agency stated that "a causal relationship has not been established" between acetaminophen use during pregnancy and autism, and acknowledged the existence of "contrary studies in the scientific literature."
India's pharmaceuticals and medical devices industries are still hopeful that trade negotiations with the US could cut a fairer deal for both sides, after President Donald Trump announced a 25 per cent tariff rate on India on a social networking platform without divulging the finer details.
A non-cognisable offence is being filed against Shiv Sena MLA Sanjay Gaikwad in connection with the assault of a canteen worker at the MLA hostel. The incident sparked outrage after a video surfaced showing Gaikwad assaulting the worker over allegedly stale food.
Study suggested that constant use of Semaglutide may be linked to development of a condition called non-arteritic ischemic optic neuropathy.
A civic body in North Goa has banned the sale of the popular street food 'Gobi Manchurian' at roadside stalls in its jurisdiction after concerns were raised about the unhygienic conditions in which the dish was prepared, an official said on Tuesday.
'We recently launched Yesintek in the immunology space.'
State governments have requested the Centre for export incentives, lifting of import duty in the case of cotton for the textile sector and GST exemptions.
'We are looking at what kind of products, diagnostics or other solutions we can offer to become a well-rounded player in a particular disease area globally.'
The controversy has sparked reactions across states. The famous Mankameshwar temple in Uttar Pradesh has now banned offerings of 'prasad' bought by devotees from outside and said they can offer homemade 'prasad' or fruits.
After falling 17 per cent since the start of the year to its March lows, the stock of the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries, has clawed back nearly half of those losses. Recent acquisitions, a favourable court ruling in the case of the hair loss drug Leqselvi, an edge over peers owing to its specialty portfolio, and a diversified global presence have supported the recovery.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing. As per the US Food and Drug Administration's Enforcement Report, the US-based arm of Sun Pharmaceutical Industries is recalling lots of Diltiazem Hydrochloride extended-release capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats.
The USTR report, released just ahead of the US' April 2 deadline for implementing reciprocal tariffs, has also cited high tariffs and price caps, which have not increased in line with inflation, as key obstacles for US businesses.
The habit, coupled with a sedentary lifestyle and poor diet, is putting increased strain on the rectal area, leading to painful conditions that often require medical intervention.
India's largest drug maker Sun Pharmaceutical on Thursday posted a decline of 19 per cent year-on-year (Y-o-Y) for its consolidated net profit for the fourth quarter of the financial year 2025 (Q4FY25) at Rs 2,149.8 crore. Meanwhile, its revenue from operations rose by 8 per cent at Rs 12,958.8 crore.
Amid the ongoing controversy over Tirupati laddu, Consumer Affairs Secretary Nidhi Khare on Monday said her department will consider additional measures to monitor ghee quality in the market only after receiving the Food Safety and Standards Authority of India (FSSAI) report.
Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices. In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI).
Shiv Sena's Dadaji Bhuse is the new school education minister while Uday Samant continues to be the industries minister.
Taking cognisance of incidents of spitting and mixing of urine in eatables in Uttar Pradesh, Chief Minister Yogi Adityanath on Tuesday directed that the name and address of operators, proprietors and managers should be mandatorily displayed at all food centres.
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
"India is not only buying massive amounts of Russian Oil, they are then, for much of the Oil purchased, selling it on the Open Market for big profits," Trump said in a social media post on Monday.
A United States court has sentenced an Indian oncologist and his wife for using unapproved chemotherapy medications at their cancer institute for three years.
Many say trend could lead to concerns on manufacturing quality in Indian facilities.
Oral paracetamol and another cough medicine manufactured by companies based in Mumbai and Punjab were found to be "sub-standard or found to be containing toxins", reports Sohini Das.
Drug shortages in the US are at an all-time high, and price erosion has stabilised, which could benefit Indian pharmaceutical (pharma) companies with a US focus, according to analysts. Nuvama Research analysts said that US price erosion seems to have normalised to its old levels of 6-8 per cent and volumes are picking up with easing of inventory. Similarly, an ICICIdirect analyst noted: "Price erosion intensity has now moderated to a single digit and is expected to tone down a
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
Natco Pharma's anti-cancer drug, NRC-AN-019, has received 'Orphan Drug' designation from the US Food and Drug Administration (USFDA) for three indications - glioma (brain tumour), pancreatic cancer and chronic myelogenous leukemia.
Regulator says fee would enable it to quicken approval process.
Ranbaxy Laboratories Ltd said on Thursday that it has bagged the US Food and Drug Administration's approval for manufacturing and marketing Loratadine and Pseudoephedrine Sulfate Extended-release tablets.
Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.
Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
In the final part of a three-part series on America's war on substandard Indian generic drugs, Aziz Haniffa speaks about American doctors' contempt for drugs exported from India and the ineptitude of the US Food and Drug Administration to stop the menace.
Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration.
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