Page 2 - Drugs

Glenmark Pharma to launch Ropivacaine Hydrochloride Injection USP in US

The product is approved as bioequivalent and therapeutically equivalent to the reference listed drug, Naropin Injection, marketed by Fresenius Kabi USA LLC

Biocon gets Health Canada nod for biosimilars Yesintek, Yesintek IV

Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has received an approval from Health Canada for chronic autoimmune conditions treatment medications Yesintek and Yesintek IV. The notice of compliance (NOC) granted by Health Canada is for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), Biocon Ltd said in a regulatory filing. Yesintek and Yesintek IV are biosimilars to Stelara (ustekinumab injection) and Stelara IV (ustekinumab for injection, solution for intravenous infusion), respectively. The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October, the company said. "Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said, "Building on our successful US launch, this approval strengthens our presence in ...

Govt to bring law for strict quality checks, monitoring of drugs, cosmetics

Amid growing demand for stricter compliance with safety and quality control norms for medical products, the Centre is framing a law to strengthen the legal framework for drug quality testing and market surveillance, along with regulation of medical devices and cosmetics. One of the major reasons behind the drafting of the law is the repeated complaints and concerns flagged by health regulators across the globe, including the WHO, over serious quality lapses by Indian drug manufacturers. The draft of the 'Drugs, Medical Devices and Cosmetics Act 2025', which the government aims to introduce in the upcoming Winter session of Parliament, was presented by Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi at a high-level meeting of the Union health ministry held on Tuesday, the sources said. The meeting was chaired by Union Health Minister J P Nadda. During the meeting, senior officials from the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control

US, Venezuela clash at emergency UN meeting over strikes in Caribbean

The United States clashed with Venezuela and its allies at an emergency meeting of the UN Security Council on Friday, with the Trump administration vowing to use its full might to eradicate drug cartels and the Maduro government saying it anticipates an armed attack. Venezuela asked for the meeting of the UN's most powerful body following deadly US military strikes on four boats that Washington says were carrying drugs. Venezuela accused US President Donald Trump of seeking to topple President Nicols Maduro and threatening peace, security and stability regionally and internationally. The Trump administration has said three of the targeted boats set out to sea from Venezuela. The strikes, which the US said killed 21 people, followed a buildup of US maritime forces in the Caribbean unlike any seen in recent times. The belligerent action and rhetoric of the U.S. government objectively point to the fact that we are facing a situation in which it is rational to anticipate that in the ve

Cough syrup deaths: NHRC sends notices to MP, Rajasthan, Uttar Pradesh

NHRC issues notices to MP, Rajasthan and UP, asks states to probe children's deaths from alleged use of contaminated cough syrups

Eli Lilly to invest over $1 billion in India to boost manufacturing

Eli Lilly, which launched its obesity drug Mounjaro in India earlier this year, plans to invest $1 billion to strengthen manufacturing partnerships and set up a new Hyderabad facility

Cough syrup tragedy: Health secy likely to hold meet on drug quality today

The conference aims to discuss the rational use of cough syrups and ensure the quality of drugs following multiple child deaths linked to Coldrif cough syrup

WHO flags surge in drug-resistant bacteria, warns of innovation crisis

Beyond the lack of new and innovative drugs, significant gaps remain in the types of treatments available

Wockhardt files new drug application with USFDA for antibacterial drug

Drug firm Wockhardt on Wednesday said it has submitted a new drug application for its novel antibacterial drug with the US health regulator. The company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (USFDA) for its novel antibacterial agent Zidebactam-Cefepime injection, the Mumbai-based drugmaker said in a regulatory filing. The NDA seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR), it added. In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the global burden of Gram-negative infections, the drug firm stated. "This milestone marks the first-ever NDA submission to the US FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation," Wockhardt Ltd said. The NDA submission follows

Weight-loss drug Ozempic receives CDSCO approval for India launch

Experts say Ozempic's entry is expected to give a boost to the antiobesity market, estimated to be ₹752 crore. Of this market, semaglutide accounts for ₹426 crore

Datanomics: India doubles its share in prescription drugs to the US

The Indian pharma stocks tanked after the announcement due to the ambiguity surrounding the impact of tariff on complex generics and specialty medicines supplied by the Indian pharma companies

US sanctions 2 Indians for supplying counterfeit fentanyl-laced pills

The US treasury department has sanctioned two Indians and an online pharmacy for selling counterfeit fentanyl-laced pills, blocking their assets and warning of tough action on drug traffickers

Lupin gets tentative nod from USFDA for generic HIV treatment drug

Pharma major Lupin Ltd on Wednesday said it has received tentative approval from the US health regulator for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets used to treat human immunodeficiency virus (HIV) infection. The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets of strength 50 mg/200 mg/25 mg, Lupin said in a regulatory filing. This product would be manufactured at Lupin's Nagpur facility, it added. Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc., and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg, it added. Citing IQVIA MAT July 2025 data, Lupin said the Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (Biktarvy) had

CDSCO flags 3 spurious drugs, 94 not of standard quality in August

CDSCO flagged three spurious drugs, including Pan D, Pan 40 and diazepam injection, and listed 94 medicines as not of standard quality in its August 2025 surveillance update

Trump lists 23 major drug transit nations, including India, Pak, and China

The US President expressed commitment to defeating the threat posed by the illegal drug trade in the US

India among top global contributors in reporting drug adverse events: DGCI

India ranks among the top contributors globally in reporting adverse events, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi said on Wednesday. He made the remarks at an event as he highlighted the growing role of pharmacovigilance in safeguarding patient health. The Indian Pharmacopoeia Commission (IPC), functioning as the National Coordination Centre for the Pharmacovigilance Programme of India (NCC-PvPI), inaugurated the 5th National Pharmacovigilance Week (NPW) at the Bharat Mandapam Convention Centre. The National Pharmacovigilance Week is being observed from September 17 to September 23 under the theme 'Your Safety, Just a Click Away: Report to PvPI'. The week-long campaign aims to sensitise healthcare professionals, regulators, researchers and the public to actively report adverse drug reactions (ADRs) through simplified digital platforms. "Initiation of National Pharmacovigilance Week in the journey of pharmacovigilance in the country has changed the course

Novartis' Vymada patent revoked, generics set to slash prices by 70%

Novartis lost its Vymada patent in India, enabling generic drugmakers to launch versions that could slash prices by up to 70 per cent and improve access for cardiac patients

Modi govt determined to wipe out drug menace from India, says Amit Shah

The Narendra Modi government is determined to wipe out all kinds of narcotics from the nation and is making an all-out effort to achieve this goal, Union Home Minister Amit Shah said on Tuesday. Addressing the Second National Conference of Heads of Anti-Narcotics Task Force (ANTF) of States and Union Territories, he also said the time has come to change the scale of action against the drug menace so that there are more successes in the coming days. The conference, organised by the Narcotics Control Bureau (NCB), began here on Tuesday. The home minister said Prime Minister Modi has set a target of 2047 to make India a fully developed and great nation. To achieve this dream of PM Modi, the country has to be fully secure, he said. "The Modi government is determined to wipe out the drug menace from the country and is making all-out efforts to achieve this goal," Shah said. "PM Modi has set forth the vision of creating an India by 2047 that will be the world's number one in every aspec

Medicinal cannabis sparks concern in Australia over psychosis, poisonings

More than 1,000 unapproved medicinal cannabis products are available in Australia. People often take these for conditions where we have no strong evidence they work

Thai cannabis industry eyes revival under new PM who backed its rise

Since Anutin decriminalised marijuana in 2022 as health minister, making Thailand the first Asian nation to do so, the industry has been whiplashed by a series of policy reversals