The US Food and Drug Administration (USFDA) recorded a significant decline in serious regulatory findings at Indian drug manufacturing facilities between January and December 2025. Data reveals that 'official action indicated' (OAI) cases - the most severe classification - nearly halved over the past year.
The European Union's (EU's) offer to slash tariffs on 97.5 per cent of Indian chemical exports to zero is set to give India's pharmaceutical and medical device firms preferential access to the European markets.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
The Supreme Court of India has ruled that stem cell therapies for Autism Spectrum Disorder (ASD) can only be offered within approved and monitored clinical trial settings, deeming any other use unethical and potentially malpractice.
India's drug regulator CDSCO has recalled three cough syrups and halted their production after the WHO raised concerns about potential contamination and links to child deaths. The WHO is investigating reports of pediatric illnesses and deaths in India potentially linked to contaminated syrups.
Among the commonly used analgesic formulations (painkillers) found NSQ are combinations of paracetamol with ibuprofen, diclofenac and mefenamic acid. Medications using these combinations are commonly used to treat fever, mild migraine, period and muscle pain.
The Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.
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.
Firms could lose licence if products not launched within 6 months of approval.
A special investigation team (SIT) has been formed in Madhya Pradesh to investigate the deaths of 14 children in Chhindwara, suspected to be linked to a toxic cough syrup. The investigation includes arrests, exhumations, and a ban on the implicated cough syrup.
The UK government has announced a new road safety strategy, including 'Dev's Law' named after an Indian-origin boy killed in a road accident, to reduce deaths and serious injuries on British roads.
The Indian Medical Association (IMA) has defended a doctor arrested in connection with cough syrup deaths in Madhya Pradesh, attributing the incident to failures in the drugs regulatory system.
This innovation works by stimulating our natural organs so that it can produce and maintain the insulin balance.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
The top three contenders for 2025 were -- rage bait, aura farming and biohack.
'Anti-cancer, anti-diabetic, and other drugs suspected to be spurious were seized from the raid carried out at the firm.'
Various domestic companies such as Ranbaxy, Wockhardt and Agila Specialities recently came under the US FDA scanner for lapse in manufacturing practices.
Delhi-based pharma major Mankind Pharma on Wednesday announced a collaboration with OpenAI to institutionalise artificial intelligence (AI) across its value chain, making it one of the first few Indian pharmaceutical companies to fully integrate advanced AI into its core operations.
Companies asked to give data for three batches instead of one; move may lead to significant rise in development cost of generics
Dr Sulbha Arora, clinical director and fertility specialist at Nova IVF Fertility, explains everything you need to know about egg freezing in India, including the process, the cost and the risks involved.
'Even as the Supreme Court's anti-punitive demolition judgment nears its first anniversary, no formal contempt proceedings have been initiated either by the Supreme Court or any high court against officers or demolition squads who have acted in violation of it.'
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as 'cocktail' drugs.
The joint inspections is to ensure the safety, efficacy, and quality of drugs available in the country
As the potential threat of a steep 200 per cent tariff on pharmaceutical imports hangs in the air, analysts and industry insiders feel that focus on exports to non-US regions as well as domestic market will increase as a long-term trend. US President Donald Trump told CNBC's Squawk Box in the first week of August that planned tariffs on import of pharmaceutical products to the US could eventually reach up to 250 per cent.
The Central Drugs Standard Control Organisation (CDSCO), the apex drug regulator, may soon ban the production and sale of three medicines in the country. The drugs - cisapride, phenylpropanolamine (PPA) and human placenta extracts - have been controversial medicines for their alleged adverse reactions for several years now.
Not only chemists, but several known private hospitals are selling medicines at higher prices than MRP, said Singh, adding that the matter was not peculiar to Punjab, but afflicts the whole country.
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.
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."
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
'Parents only realise the trap in which their children fell after losing money. Some exploit children for sexual acts such as pornography and the narcotics trade.'
'This is the first case in which we saw use of Starlink by smugglers.'
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.
Members of the IMA and IPA had met Mansukh Mandaviya on Monday and expressed their concerns over the regulations.
The regulator had issued alerts in June and July of 2015.
Roche expects to start selling Actemra by April 2009, company sources said. India will be the second country to launch the drug, Japan being the first. The Indian drug regulator Drug Controller General of India usually approves a new drug marketing application based on safety and efficacy data cleared by regulators in the US, EU and other developed countries.
All doctors must prescribe generic drugs, failing which they will be penalised and even their license to practice may also be suspended for a period, according to the new regulations issued by the National Medical Commission (NMC).
Who else will take on the might of Microsoft, Google, and Amazon if not the Adanis, Ambanis, Birlas, or Tatas?, asks R Jagannathan.
Orders surprise inspections at chemists and pharma stores.
India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.
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.
