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.

Amid an India-wide strike of more than 15 lakh chemists and druggists slated for May 20, the government today noted that access to medicines will remain unaffected in the country.

“All pharmacy chains and hospital pharmacy stores, Jan Aushadhi stores, AMRIT Pharmacy stores will remain open tomorrow,” according to official sources from the Ministry of Health.

These stores will remain open “in addition to the many state and chemist associations who have already pulled out from the strike,” the sources said.

Retail pharmacy associations from at least 12 states and Union Territories, including West Bengal, Kerala, Maharashtra, Punjab, Karnataka and Uttar Pradesh, have formally distanced themselves from the strike call, citing “public interest”.

What Is The Nationwide Chemists’ Strike About?

Earlier this week, the All India Organisation of Chemists and Druggists (AIOCD) announced that more than 15 lakh chemists and druggists across the country will keep their medical stores shut on May 20 to protest against illegal online sale of medicines and “unprofessional competition” by corporate firms.

The trade body flagged the sale of prescription drugs without proper verification and warned that AI-generated fake prescriptions may worsen the misuse of antibiotics.

The nationwide strike also demands the withdrawal of notifications issued during the COVID-19 pandemic that allegedly enabled the misuse of online medicine sales, said AIOCD president and former MLC Jagannath Shinde during a press conference in Mumbai.

Shinde noted that online sales had led to the circulation of fake drugs, antibiotics, and scheduled medicines without prescriptions, posing a serious threat to public health, particularly among the youth.

Also read: ‘I Was Vocal About Cancer But Silent About Menopause Out Of Shame’, Says Actress Lisa Ray

“The online sale of drugs has become hazardous for the nation and needs to be checked on priority. Moreover, deep discounts offered by online companies were proving to be a death knell for small chemists and retailers,” he alleged.

During the COVID pandemic, the government had issued special exemptions to ensure home delivery of medicines. Shinde pointed out that those provisions are continuing even after the pandemic ended.

Online companies were exploiting these relaxations and engaging in unfair competition through discounts ranging from 20 to 50 per cent, he added.

CDSCO Reviewing Retail Pharmacy Concerns

Read More: No Ebola Case in India, Public Risk Low: Govt Steps Up Surveillance at Airports and Seaports

Official sources in the Central Drugs Standard Control Organisation (CDSCO) reiterated that public health and patient access to medicines remain paramount.

They noted that any disruption in the functioning of chemist shops has the potential to cause serious inconvenience to patients, particularly vulnerable groups dependent on regular access to life-saving and essential medicines, besides impacting critical medical supply chains.

“Any disruption in the functioning of chemist shops has the potential to cause serious inconvenience to patients and impact critical medical supply chains,” a source said.

They also added that constructive dialogue remains the preferred mechanism for addressing sectoral concerns while ensuring uninterrupted healthcare services for citizens across the country.

The 17th outbreak of Ebola virus in the Democratic Republic of the Congo has claimed over 130 lives, with more than 513 suspected cases, local officials have said.

A spokesperson for the DR Congo government said cases were now being reported across a wider area, according to the BBC. Cases are now being identified in new areas, including Nyakunde in Ituri Province, Butembo in North Kivu, and the city of Goma.

As per the US Centers for Disease Control and Prevention (CDC), there are also two confirmed cases and one death in Uganda.

The World Health Organization (WHO) has declared the current outbreak, caused by the Bundibugyo virus, an international emergency. The agency has also warned that it could potentially become “a much larger outbreak” than what is currently being detected and reported, with a significant risk of local and regional spread. However, it does not meet the criteria of a pandemic.

Meanwhile, an American doctor in the DR Congo who was caring for patients also tested positive for Ebola Bundibugyo disease on May 17.

“The person developed symptoms over the weekend and tested positive late on Sunday,” the CDC said, adding that the agency is working to move the patient to Germany for treatment and care.

CBS News also quoted sources as saying that at least six Americans have been exposed to the Ebola virus during the outbreak in the DR Congo.

The CDC noted that "high-risk contacts associated with this exposure are also being moved to Germany".

The Bundibugyo Virus: Previous Outbreaks

The Bundibugyo virus has previously caused two recognised outbreaks. The first was in Bundibugyo District, Uganda, in 2007–2008, with 131 reported cases and 42 deaths, and a case fatality rate of 34–40 per cent.

The second was in Isiro, Democratic Republic of the Congo, in 2012, with 38 laboratory-confirmed cases and 13 deaths, although wider outbreak reports, including probable and suspected cases, gave higher totals.

These figures are lower than the fatality rates seen in many outbreaks caused by other Ebola strains, but they are still extremely serious.

Also read: Ebola Outbreak: University of Glasgow Researcher Explains Why Bundibugyo Virus Is Concerning

The largest outbreak of the Ebola virus since its discovery in 1976, took place in 2014–2016. The outbreak infected more than 28,600 people in West Africa.

The disease also spread to several countries within and outside West Africa, including Guinea, Sierra Leone, the United States, the United Kingdom, and Italy, killing 11,325 people.

How Does Ebola Bundibugyo Spread?

The Bundibugyo virus spreads through contact with the blood or bodily fluids of a person infected with, or who has died from, the rare Ebola strain.

It can also spread through contact with contaminated objects such as clothing, bedding, needles, and medical equipment, or through infected animals such as bats and nonhuman primates.

Historically, Bundibugyo virus outbreaks have recorded fatality rates ranging from 25 per cent to 50 per cent.

Symptoms To Watch For

Symptoms of Bundibugyo virus disease are similar to other forms of Ebola and include:

• Fever
• Headache
• Muscle pain
• Weakness
• Diarrhea
• Vomiting
• Stomach pain
• Unexplained bleeding or bruising, usually in later stages of illness.

The ongoing Ebola virus outbreak in the Democratic Republic of Congo, which has also spread to Uganda, has been identified as caused by the rare Bundibugyo strain.

As per the US CDC, as of May 17, there are reports of 10 confirmed cases and 336 suspected cases, including 88 deaths, in DRC.

Uganda has reported 2 confirmed cases, including 1 death, among people who travelled from DRC. No further spread has been reported. These numbers are subject to change as the outbreak evolves.

Speaking exclusively to HealthandMe, Professor Emma Thomson, Director of the Centre for Virus Research (Virology) in the School of Infection and Immunity at the University of Glasgow, shared why the virus outbreak, which has been declared a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), is of concern.

While the Bundibugyo virus, a member of the species Orthoebolavirus bundibugyoense, is closely related to the Ebola virus (species Orthoebolavirus zairense), it is still different and currently has no treatment or vaccine.

Professor Emma told HealthandMe that “there are several reasons for concern".

Ebola Outbreak: Likely Went Undetected For Some Time

The expert noted that "the reports that initial GeneXpert Ebola testing was negative suggest that the outbreak may have gone undetected for some time, with early diagnostic blind spots delaying recognition".

There have also been reports of infections in healthcare workers, which is "a serious warning sign in any filovirus outbreak, because they indicate unrecognized transmission in healthcare settings and gaps in infection prevention and control", the Professor said.

Notably, Ebola cases have been identified in Kinshasa and Kampala. These are "hundreds of kilometres from Ituri province, and it shows that the virus has already moved through human mobility networks before full containment was in place," Professor Emma said.

The Bundibugyo virus: Previous Outbreaks

The Bundibugyo virus has previously caused two recognized outbreaks. The first was in Bundibugyo District, Uganda, in 2007–2008, with 131 reported cases and 42 deaths, and a case fatality proportion of 34–40 per cent.

The second was in Isiro, Democratic Republic of the Congo, in 2012, with 38 laboratory-confirmed cases and 13 deaths, although wider outbreak reports, including probable and suspected cases, gave higher totals.

These figures are lower than the case fatality rates seen in many outbreaks caused by the Ebola virus, but they are still extremely serious. "Bundibugyo virus disease is not a mild infection," the expert said.

Ebola virus: Vaccine And Therapeutics

Currently, there is a licensed vaccine that targets the Ebola virus from the species Orthoebolavirus zairense (rVSV-ZEBOV).

"Experimental non-human primate work suggests that rVSV-ZEBOV may provide partial heterologous protection against Bundibugyo virus, but this cannot be assumed to translate into reliable protection in people during an outbreak," Professor Emma noted.

"Adenovirus- and MVA-vectored vaccine platforms may offer broader possibilities, particularly where multivalent constructs are used, but recent immunological data suggest that some licensed or advanced platforms still induce responses that are predominantly directed against the Ebola virus rather than broadly cross-reactive across all ebolaviruses," she added.

In other words, "we do not currently have a proven, licensed, Bundibugyo-virus-specific vaccine available for outbreak control," the Professor said, stressing the need for "urgent research" on vaccines.

Similarly, she stressed the need to boost "therapeutics" against the Ebola virus.

"Approved monoclonal antibody treatments such as Inmazeb and Ebanga were developed for the disease caused by the Ebola virus, not Bundibugyo virus, and their efficacy against other ebolaviruses has not been established," Professor Emma told HealthandMe.

"There are promising experimental broad-spectrum antibodies, but these are not yet a substitute for rapid detection, high-quality supportive care, infection prevention and control, and contact tracing," she added.

Bundibugyo-virus OutbreaK: What Should Be Prioritized?

Professor Emma further called for ramping up practical and scientifical priorities. These include:

• the Bundibugyo-virus-capable diagnostics,
• rapid genomic sequencing,
• strong infection prevention in healthcare settings,
• safe clinical pathways,
• contact tracing,
• community engagement,
• treatment centres able to deliver high-quality supportive care.

The expert also stressed the importance of genomic sequencing as it can:

• confirm the virus species,
• Identify whether cases are linked,
• reconstruct transmission chains,
• Detect whether the outbreak reflects sustained human-to-human transmission or multiple introductions.

“This outbreak also highlights a persistent weakness in epidemic preparedness. We tend to build tools around the best-known outbreak pathogens, but rarer viruses such as Bundibugyo virus can still cause severe disease and international spread," Professor Emma said.

The expert also highlighted the essential need for

• sustained investment in high-containment laboratories,
• diagnostic development,
• genomic surveillance,
• vaccine platforms,
• therapeutics and international research partnerships.