The Union Health Ministry implemented a ban on 156 "irrational" FDC medicines, effective immediately. These medicines, including widely used antibiotics, painkillers, and multivitamins, were commonly used to treat fever, cough, and infections. The ban was imposed due to the associated health risks and lack of therapeutic justification for the ingredients in these FDCs.

What are FDC medicines?

FDCs or fixed-dosed combinations, also known as "cocktail drugs," are medications that combine multiple drugs in a single pill. They are designed to treat multiple symptoms or conditions simultaneously. While they offer convenience, they can pose significant risks. These risks include the possibility of overdose, adverse interactions between the drugs, and the development of antibiotic resistance. Additionally, many FDC medicines lack sufficient scientific evidence to support their safety and efficacy.

Expert opinions on FDC medicines

Experts have raised concerns about the use of FDC medicines. They believe that many of these combinations lack sufficient scientific evidence to support their safety and effectiveness. Additionally, the combination of multiple drugs in a single pill can increase the risk of adverse side effects and interactions with other medications.

Experts have also found that FDC medicines may not be as effective as individual drugs in treating certain conditions. It is important to note that safer and more effective alternatives are available for most of the medical conditions that FDC medicines were used to treat. One particular concern is the inclusion of antibiotics in some FDCs. Overuse of antibiotics can contribute to the development of antibiotic resistance, a major public health threat.

The risks of FDC medicines

The use of FDC medicines can lead to adverse effects, including serious ones. Additionally, safer alternatives, tested in clinical trials, are available to treat the same medical conditions. Experts recommend prescribing drugs individually based on a patient's clinical symptoms rather than combining them in FDCs.

The ban on irrational FDC medicines by the Union Health Ministry can be seen as a positive step towards promoting rational drug use and protecting public health. The goal is to eliminate unnecessary and potentially harmful drug combinations. This is a step forward in reducing the risks associated with medication and ensure safer and more effective treatment options for patients.

Medicine safety must become everyone’s responsibility, the Indian government said today while launching the Biovigilance Program to monitor adverse events linked to organ and tissue transplantation.

Under the program, the Indian Pharmacopoeia Commission (IPC) will lead efforts to strengthen the reporting, assessment, monitoring and prevention of adverse events associated with medicines and biological products used in organ and tissue transplantation, including products administered to donors and recipients.

Together, pharmacovigilance, materiovigilance and biovigilance initiatives will strengthen safety monitoring across medicines, medical devices and transplant procedures.

The program was launched by Union Minister of State for Health & Family Welfare and Chemicals & Fertilizers Anupriya Patel at the 6th National Pharmacovigilance Week organized by the IPC at Dr. Ambedkar International Centre in New Delhi.

New Medicine Safety Initiatives

Patel also launched initiatives to help healthcare professionals make informed, evidence-based decisions when prescribing and using medicines. These include:

• The 7th Edition of the National Formulary of India (NFI),
• The Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Device-Related Adverse Events,
• The ADR-PvPI 2.0 Mobile App for iOS users.

“Rational use of medicines and continuous safety monitoring are integral to public health,” said Patel. She added that “every patient must receive the right medicine, of assured quality, in the right manner and with the highest possible degree of safety”.

“The NFI serves as an important bridge between scientific standards and clinical practice, guiding healthcare professionals in the appropriate and rational use of medicines,” Patel said.

India’s Pharmacovigilance Network

Patel emphasized that medicine safety is a continuous responsibility—from the development and manufacture of a drug or medical device to its prescription, dispensing, use and post-market monitoring.

She also highlighted the country’s progress in pharmacovigilance, noting that “India has built a strong indigenous ecosystem capable of generating, collecting, processing and analyzing medicine-safety data from across the country”.

India has moved from the 123rd position during 2009–2014 to 8th globally in contributions to the WHO patient safety database, Patel said.

The Pharmacovigilance Program of India (PvPI), coordinated by the National Coordination Centre at IPC, systematically collects, assesses and analyzes adverse drug reaction information. The Materiovigilance Program of India (MvPI) monitors adverse events associated with medical devices.

AI And Patient Reporting

Patel said digital initiatives, including NFI Online, IP Online, ADR-PvPI 2.0 Mobile App and the Adverse Drug Reaction Monitoring System (ADRMS), are making medicine-related information and adverse-event reporting more accessible, transparent and responsive.

She called for greater use of emerging technologies, including artificial intelligence and advanced data analytics, to strengthen medicine-safety systems and enable timely generation and use of safety evidence.

The Minister also stressed the need to increase patient participation in adverse-event reporting. She noted that digital platforms, mobile applications and helplines have made reporting easier, and called for addressing the “missing link” of patient reporting.

"Around 1,150 ADR reporting centers are currently operational across public and private hospitals and medical colleges in the country, along with medical-device vigilance facilities. The government plans to expand these capabilities to the primary healthcare level," Patel said.

India’s Patient Safety Push

Referring to the vision of Viksit Bharat 2047, Patel said patient safety must remain a key national priority. She called for India to build on its position as the “pharmacy of the world” and aspire to become a global leader in pharmacovigilance sciences and patient safety.

“Medicine safety must become everyone’s responsibility. Every single reported event can save a life.”

She said collective participation would be critical to building a strong culture of medicine safety and promoting the rational use of medicines.

An LSD-based treatment has cleared its second Phase 3 trial for generalized anxiety disorder (GAD), sparking hope to bring the first new drug for the condition in nearly two decades closer to FDA approval.

Definium Therapeutics recently said that its drug DT120, a tablet containing lysergide, the pharmaceutical form of LSD, significantly reduced anxiety symptoms compared to placebo in the Panorama Phase 3 trial that included 245 participants.

The company said participants receiving a single 100-microgram dose had a 9.8-point reduction in their score on the Hamilton Anxiety Rating Scale (HAM-A) after 12 weeks, compared to a 4.7-point reduction among those receiving placebo. The difference with placebo was 5.1 points.

The improvement surfaced quickly as differences from placebo seen as early as Day 2 and sustained through the 12-week assessment.

A Promising Second Phase 3 Trial

Also read: World Patient Safety Day: Why Insulin Innovation in Diabetes Care Demands an Ecosystem Approach

Panorama is the second positive Phase 3 trial for DT120 in GAD. An earlier Phase 3 study, called Voyage, also found a significant improvement in anxiety symptoms, with a placebo-adjusted difference in HAM-A of 5.4 points at 12 weeks.

Phase 3 trials are generally the pivotal studies in any research as they are used to provide evidence of a treatment's efficacy and safety before regulatory review and approval.

Rob Barrow, Chief Executive Officer of Definium Therapeutics, said, “The Panorama results again met our high expectations and confirmed the unprecedented efficacy of DT120 in GAD.”

Barrow added, “With strong positive results across four complementary studies, we have built a compelling body of evidence that increases our confidence in the potential best-in-class profile of DT120.”

The drug also hopes to bridge the long-overdue treatment gap in GAD. Definium says the last new drug approved for GAD was in 2007, meaning DT120 could potentially become the first newly approved GAD treatment in almost 20 years if it ultimately clears regulatory review.

Definium has a pre-New Drug Application meeting with the US Food and Drug Administration planned for the fourth quarter of 2026 and anticipates filing its application in the first half of 2027.

Barrow also said, “Building on this momentum, we are advancing toward an NDA submission and look forward to aligning with the FDA at our upcoming pre-NDA meeting. We are deeply grateful to the participants, investigators, site personnel, and our team whose commitment and hard work made this progress possible.”

Also read: After Lindsay Clancy Trial, Massachusetts Pushes Stronger Postpartum Mental Health Screening

LSD-Based Treatment For GAD

DT120 is designed as a single-dose treatment rather than a daily tablet. In the Panorama trial, participants were monitored for at least eight hours after dosing because LSD can temporarily lead to certain cognitive and emotional changes.

Among those receiving 100 micrograms, the average time to meet the study's end-of-session criteria was 6.2 hours, while 94% met those criteria within eight hours.

The treatment works through the serotonin 5-HT2A receptor, although exactly how LSD produces longer-lasting improvements in psychiatric symptoms remains unclear.

The company reported that DT120 was generally well tolerated. It also said that side-effects were mild to moderate, temporary and occurring mainly on the day of dosing.

Among people receiving the 100-microgram dose, common adverse events on dosing day included illusions in 68%, nausea in 37% and headache in 24%. There were no drug-related serious adverse events or signals of increased suicidality in the trial, according to Definium.

It is important to know that these results are reported by the company, and the complete data will need regulatory and scientific scrutiny for the drug’s approval.

Physicist Stephen Hawking lived with amyotrophic lateral sclerosis (ALS) for more than five decades. Diagnosed at 21 in 1963, he was initially given just two years to live. However, his early-onset form of ALS progressed unusually slowly. Hawking died on March 14, 2018, aged 76.

Now, US researchers have developed a personalized RNA therapy for a rare genetic form of ALS and administered it to a single patient. One year after treatment, the patient showed improvements in physical function and a key biomarker of nerve damage.

ALS, also known as motor neuron disease (MND) or Lou Gehrig’s disease, affects nerve cells in the brain and spinal cord that control voluntary movement. As these neurons deteriorate, muscles become progressively weaker and can eventually lead to paralysis.

What Was The New RNA Therapy?

Researchers at the Mayo Clinic developed an antisense oligonucleotide (ASO) therapy, a personalized RNA-based treatment designed to target RNA produced by the mutated gene and reduce the production of specific proteins.

Unlike conventional gene therapy, which aims to alter a person's genetic material, ASO therapy uses short strands of genetic material called “oligonucleotides,” to target RNA, according to the findings, published in the international journal Med.

These oligonucleotides prevent the production of the proteins that cause ALS.

It was administered on the male patient who had slowly progressive ALS, with onset in his right shoulder in 2020. In 2018, he underwent a spine surgery for radiating left neck and arm pain with mild weakness.

It was in 2021 that he was diagnosed with ALS caused by a mutation in the CHCHD10 gene, found in fewer than 1% of people with hereditary ALS.

Defects in CHCHD10 can damage mitochondria, which produce energy inside cells, ultimately contributing to nerve-cell death and ALS.

Patient's ALS Symptoms Improved

The patient received six spinal injections between April 2024 and April 2025. The first three doses were 50 milligrams each, followed by three 75-milligram doses.

One year after the first dose, the patient's blood levels of neurofilament light chain (NfL) had fallen by about 50% and returned to the normal reference range.

NfL is a protein released when nerve cells are damaged and is used as a biomarker of neurodegeneration and ALS progression.

The patient's score on the Revised ALS Functional Rating Scale (ALSFRS-R) also increased from 33 to 36 over the year. The scale measures physical function in people with ALS.

Other measures of breathing and cognition remained stable, and the patient showed no signs of cognitive decline during the reported follow-up.

"To date, the ASO has been well tolerated, with a good safety profile, and has demonstrated early signs of efficacy. The patient reports subjective improvement, and our primary response biomarker, neurofilament light (NfL), has normalized," the research team wrote in the paper.

The patient’s symptoms improved one year after receiving the drug, and he continues to work as a physician, Nature reported.

“We have shown that it is possible to develop a personalized ASO therapy for CHCHD10-related ALS,” adding that this provides “evidence suggesting the potential for therapeutic benefit in the clinic,” the research team stated.

Is This A Cure For ALS?

The findings are an early step, and it is far too soon to know whether the treatment can stop ALS progression or provide a cure.

The patient will need to be monitored for several more years, while the therapy must also be tested in additional patients to determine whether the improvements can be sustained and whether the treatment can slow disease progression.