Drugs

CDSCO expert panel grants waiver for 920 mg Ocrelizumab, subject to Roche conducting a Phase 4 clinical trial in the Indian population for proposed indications

Drug major Cipla Ltd on Thursday said its wholly owned subsidiary, Invagen Pharmaceuticals Inc, has entered into a strategic partnership with Qilu Pharmaceutical for the licensing and supply of a biosimilar to the cancer drug Keytruda in the United States. The product, QL2107, is a biosimilar to pembrolizumab (Keytruda) and aims to improve access to advanced therapies for cancer patients while lowering treatment costs, Cipla said in a regulatory filing. Under the agreement, Qilu will be responsible for the development, regulatory registration, and supply of the product, while Cipla will leverage its commercial presence to market the asset in the US. "This partnership reflects Cipla's confidence in the long-term potential of biosimilars and supports our strategy to build a strong oncology-focused portfolio," said Achin Gupta, Managing Director and Global Chief Executive Officer, Cipla. Hanchang Zhang, General Manager of Qilu Pharmaceutical, said, "We are pleased to establish this ..

The Maharashtra cabinet on Tuesday approved a policy aimed at eradicating drugs from the state by 2029 through extensive public awareness and strict action against narcotics with the participation of all departments. Maharashtra is the first state in the country to undertake such a comprehensive campaign, involving coordination among various departments, to create a drug-free state, a statement issued by the government said. Under the policy, strict action will be taken against the cultivation of crops that contribute to the production of illegal drugs, as well as the production, transportation, sale and consumption of natural and synthetic drugs. "The policy will focus on extensive public awareness and strict action against drugs, with the participation of all departments of the state government. To ensure the successful implementation of this comprehensive policy, responsibilities have been assigned from the village level to the district, divisional and ministerial levels," the ..

A "Peptide Party", scheduled for Saturday in Bengaluru, has been cancelled following a notice issued to the organisers of the event by the Karnataka Food Safety and Drug Administration Department seeking details about the event, officials said. The cancellation came a day after the FSDA sought detailed information from the organisers of the event on peptide preparations, including their composition, manufacturers, regulatory status, dosage and intended use, they said. Officials said that the proposed event was being publicised as an invite-only event featuring "peptide tastings", music, food and networking, as cited in their social media posts. Peptide parties are informal, invite-only social gatherings where biohackers, wellness enthusiasts, and fitness influencers meet to discuss, sample, or promote peptide-based products. The department has also issued an advisory to the general public regarding the "Peptide Party" event, originally scheduled to take place on August 29, in ...

Doctors call the pickup largely seasonal and say most H3N2 and H1N1 cases are being treated at home, with hospitalisations remaining limited so far

In a significant step to safeguard the health and safety of young children, the government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age. Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning. The latest notification extends this requirement to all formulations containing these two ingredients. The decision followed recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB). The government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available. Manufacturers have been directed to clearly display the warning "Fixed Do

Move follows expert concerns over potential misuse and intoxication; retailers will have to maintain detailed sales records for the four CNS medicines under Schedule H1

FIP has also proposed oral-fluid testing alongside urine tests and a 12-month pilot programme to assess its reliability, operational feasibility and cost

Thailand has become the second country after the US to approve Dr Reddy's first-in-class antibiotic zoliflodacin, a milestone that could accelerate access to the drug across emerging markets

The Maharashtra Food and Drug Administration (FDA) has barred the sale and distribution of some medicines manufactured by Cadila Pharmaceuticals Ltd and seized stock worth about Rs 2.45 crore across the state over branding similarities despite having different active pharmaceutical ingredients (APIs), officials said on Saturday. The order is linked to Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus, which have Ranitidine and Famotidine as APIs, they said. The FDA has directed the company to immediately recall all available stocks of Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus from the market over concerns that such branding could lead to medication errors. It has also barred the sale of Aciloc 150 Plus and Aciloc 300 Plus. "Any confusion caused by a medicine's brand name that could result in doctors, pharmacists or patients receiving the wrong drug is a serious public health concern," FDA Commissioner Tukaram Mundhe said in a statement. He said complianc

Oral drug formulations containing over 12 per cent ethyl alcohol will require prescriptions and licensed retail sale under new rules aimed at curbing misuse and hoarding

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

Draft amendments propose a 12-month minimum residual shelf life for imported drugs and an acknowledgement-based mechanism for importing medicines for research

The drug that has received the final approval from the US regulatory body is Oseltamivir Phosphate for Oral Suspension, 6 mg/mL

The Health Ministry will expand mandatory QR code-based traceability to vaccines, antimicrobials, anti-cancer, narcotic and psychotropic drugs in a phased rollout

The Centre has amended the Drugs Rules, 1945 and removed 'syrups' from a category under Schedule K, amid tighter oversight of cough syrups and drug safety

The US military attack in Venezuela Friday that killed the leader of the Tren de Aragua gang reflects a strategic shift by US President Donald Trump toward direct US involvement in the war on drugs that began earlier this year, with a special focus this time on gaining access to Venezuela's lucrative mining sector, analysts told The Associated Press. Trump announced Friday the death of gang leader Hector Rusthenford Guerrero in an airstrike on his compound in rural Venezuela. He has long accused Guerrero's organisation, also known as TDA, of terrorising communities across the United States, where it has been linked to extortion rackets, drug trafficking and illegal immigration. The group was listed as a foreign terrorist organization by the State Department last year, with federal prosecutors accusing Guerrero of shipping drugs to the U.S. and organizing acts of terror across borders, including the murder of a Venezuelan dissident in Chile. Venezuela's government said in a statement

India plans a new support scheme for bulk drugs focused on R&D and capacity creation, while ruling out a broad medicine price hike despite rising input costs

Novo Nordisk and Eli Lilly are expanding obesity drug access globally as demand grows beyond the US and cheaper semaglutide generics enter new markets

Novo Nordisk plans to defend its obesity drug leadership in India as semaglutide patent expiry fuels competition from nearly 50 new market entrants