Page 2 - Drugs

Govt restricts 2-compound fixed drug combinations for children under 4

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

Centre imposes strict curbs on sale of four nerve-relaxing drugs

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

Pilots' body urges DGCA to raise annual random drug testing to 25%

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

Dr Reddy's antibiotic gets Thailand approval six months after US nod

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

Maharashtra FDA bars sale of some Cadila Pharma drugs over brand confusion

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

Prescription, licence must to sell drugs with high-alcohol content

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

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

Centre proposes easing shelf-life, licensing norms for imported drugs

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

Alembic Pharma gets USFDA nod for drug to treat influenza A and B in babies

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

Centre brings vaccines, anti-cancer drugs under QR code tracking regime

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

No sale of syrups without doctor's prescription; here's what govt did

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

'US strike on Tren de Aragua leader shows Trump's approach to war on drugs'

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

Scheme to build bulk drugs' R&D, capacity in works, says Pharma secy

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

Eli Lilly and Novo Nordisk looking beyond US for obesity drug growth

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

Beyond GLP-1, Novo eyes next-gen obesity drugs: Vikrant Shrotriya

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

NPPA fixes prices of 30 drugs including Vitamin D3, calcium supplements

According to the order, the fixed retail prices are exclusive of Goods and Services Tax (GST), which may be added only if it has actually been paid or is payable to the government.

France becomes first EU country to reimburse anti-obesity drugs: Minister

Patients in France are currently paying around €300 ​per month on average for the drugs, she said, without indicating how many people currently follow such treatments

Govt to amend anti-doping law, proposes five-year jail for suppliers

Sports Minister Mansukh Mandaviya on Thursday said the National Anti Doping Act will be amended to criminalise trafficking and distribution of prohibited substances with a jail term of upto five years. The amendments have been uploaded on the sports ministry's website for requisite feedback from the public. "Whoever administers or applies to an athlete, for the purpose of or in connection with doping in sport...shall be punishable with imprisonment for a term which may extend to (five) years, or with fine which may extend up to (two lakh) rupees, or both," the amendment states. Mandaviya said the amended bill will be tabled in the next session of Parliament. "Doping is no longer just a sporting violation; it has evolved into an organised ecosystem exploiting athletes," Mandaviya said in an interaction with the media here. "We only punish those who are consuming but suppliers need to be targetted as well," he added.

AIOCD to go ahead with May 20 strike despite states opting out of protest

AIOCD will continue with its proposed nationwide strike against online pharmacies despite several state retail pharmacy associations opting out of the protest

India joins weight-loss drug race, but affordability remains a concern

India is in the race for a new class of weight-loss drugs, but the question is: Will they be affordable?