A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet.

A staggering 39 million people worldwide could succumb to antibiotic-resistant infections over the next 25 years, according to a landmark study published in The Lancet. This chilling projection underscores the urgent need to combat antimicrobial resistance (AMR) as a critical global health crisis. Conducted by the Global Research on Antimicrobial Resistance (GRAM) Project, the study is the first comprehensive analysis of AMR trends, outlining its alarming future impact.

Key Findings: AMR-Related Deaths on the Rise

The GRAM study reveals that over one million people died annually from AMR between 1990 and 2021. Even more concerning is the forecast for 2050, where nearly 2 million people are projected to die directly due to AMR each year—an increase of nearly 70% compared to 2022. Furthermore, AMR is expected to contribute to 8.22 million deaths annually by 2050, representing a 75% surge from the 4.71 million deaths recorded in 2022.

Age-Related Trends in AMR Mortality

• Children under five years old: Deaths declined by 50% between 1990 and 2021, yet AMR still poses a threat.
• Adults aged 70 and older: AMR-related deaths rose by over 80%, with this demographic expected to bear the brunt of the mortality burden by 2050.

While AMR deaths among young children are expected to halve by 2050, fatalities in older populations will more than double, highlighting the aging population’s vulnerability.

Global Health Implications of AMR

Antimicrobial resistance occurs when bacteria evolve and no longer respond to medications, rendering treatments ineffective. The consequences of unchecked AMR are far-reaching and devastating. AMR already claims more lives than HIV/AIDS and malaria combined, with 1.2 million direct AMR-related deaths in 2019 alone. By 2050, this figure will balloon to a total of 39 million deaths across all ages.

Geographic Disparities

AMR-related deaths will disproportionately affect regions such as:

• South Asia: Expected to account for 11.8 million deaths directly due to AMR between 2025 and 2050.
• Sub-Saharan Africa and Southern/Eastern Asia: These regions will also see significant rises in fatalities, driven by limited healthcare access and ineffective infection control measures.

Historical Data and Projections

The GRAM study analyzed 520 million records from hospital data, deathc ertificates, and antibiotic use across 204 countries and territories. Based on historical trends, AMR-related deaths have steadily increased since 1990, with 1.14 million deaths directly attributed to AMR in 2021.

AMR’s Most Common Culprits:

• Methicillin-resistant Staphylococcus aureus (MRSA): Deaths increased from 57,200 in 1990 to 130,000 in 2021.
• Carbapenem-resistant Gram-negative bacteria: Resistance to these antibiotics grew from 127,000 deaths in 1990 to 216,000 in 2021.

Without significant intervention, these pathogens and others will continue to fuel rising mortality rates.

The Urgent Need for Global Action

To mitigate the escalating AMR crisis, the study calls for a comprehensive global strategy focused on:

• Infection prevention and vaccination programs
• Minimizing inappropriate antibiotic use
• Research and development of new antibiotics targeting resistant bacteria
• Access to quality healthcare and antibiotic treatments

The Future of AMR: What Lies Ahead?

Based on current trends, AMR is expected to directly cause 1.91 million deaths annually by 2050, a stark 67.5% increase from 2021. In total, more than 39 million deaths will result directly from AMR between 2025 and 2050. However, with improved healthcare infrastructure and targeted development of antibiotics, an estimated 92 million deaths could be averted.

Key Solutions to Avert Catastrophe:

• Improved infection care: Particularly in regions like South Asia, sub-Saharan Africa, and Southeast Asia, better access to antibiotics could prevent millions of deaths.
• Innovation in drug development: The creation of new antibiotics targeting Gram-negative bacteria could save over 11 million lives globally by 2050.

Conclusion: A Call to Action

The findings from this study highlight the growing and evolving threat of antimicrobial resistance. Without prompt and coordinated efforts to prevent, manage, and treat infections caused by resistant bacteria, millions of lives will be at risk. Now is the time for governments, healthcare organizations, and researchers to intensify efforts to avert a global health catastrophe. 

A circular issued on ‘good manufacturing practices’ in August describes the recall procedure as well as the law in this respect, but it is doubtful whether these provisions are implemented.

A circular issued on ‘good manufacturing practices’ in August describes the recall procedure as well as the law in this respect, but it is doubtful whether these provisions are implemented. The CDSCO list (and that of States) should provide details on sample size as well as the time and place of collection. Collecting samples from distributors’, chain suppliers, as today most of the drugs r purchased from such chains for additional discounts and schemes supplied to distributors and retailers from outside States, such unethical practices must be monitored 

Finally, medicines are life and death matter. The industry needs the right dose of regulation and freedom

it is high time that both industry and government come together to deal with this menace

https://chat.whatsapp.com/Iili8jkCHeYJYi3x89OPuF

POV Admin Pharma Forum : Kamlesh Doshi

Spurious or NSQ: How India’s drug industry is evading regulatory action?

Spurious or NSQ: How India’s drug industry is evading regulatory action?

While spurious drugs and not-of-standard quality are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment. 

In a damage control effort following the latest product inspection report by India’s drug regulator, the pharmaceutical industry has issued statements that further confuse patients.

While individual drug manufacturers whose brands appeared in the August drug alert attribute the situation to the presence of spurious drugs in the market, an industry lobby contends that the real issue is the misrepresentation of the term "not-of-standard quality (NSQ)" as synonymous with "spurious" drugs. They assert that no spurious products should be linked to the industry and that the concerns over NSQ are being exaggerated.

While spurious drugs and NSQs are distinct by definition, medical experts agree that both zero-ingredient and substandard medicines are equally harmful in terms of treatment.

The Central Drugs Standard Control Organisation (CDSCO) published its August inspection report last week, naming several commonly used drug brands found to be of either NSQ or spurious quality. The alert identified leading brands such as Clavam 625 (antibiotic), Pan-D (antacid), Pulmosil Injection (hypertension), Pantocid (antacid), Telma H (blood pressure), Deflazacort (muscular dystrophy), and Paracetamol IP (anti-pyretic) among others.

The Indian Pharmaceutical Alliance (IPA) expressed deep concern over what it described as a gross misrepresentation and distortion of facts by certain media outlets regarding the CDSCO's drug alert. The IPA stated that misleading coverage irresponsibly conflates “not of standard quality” with “spurious,” unfairly implicating legitimate manufacturers in the production of counterfeit drugs.

One of the companies named in the CDSCO alert, Alkem Laboratories, denied the claims regarding its brands' quality. Alkem stated that the samples listed in the CDSCO report are spurious and not manufactured by them. The company emphasized the existence of counterfeit drugs as a significant concern, yet it appears the IPA's primary focus is not on the potential health risks posed by NSQ medicines.

The IPA highlighted that manufacturing spurious drugs is a serious criminal offense that endangers public health. The association pointed out that linking legitimate manufacturers with spurious products can severely damage reputations and have financial repercussions, ultimately tarnishing India’s standing as a reliable supplier of medicines globally. “It is critical that a clear distinction between NSQ and spurious drugs is made,” the IPA stated.

The IPA will continue to collaborate with the government to strengthen systems and implement stringent measures against spurious drugs. This issue is vital for both India’s global reputation and public health protection.

Alkem Laboratories also refuted the CDSCO claims regarding its products Pan-D (sales of Rs 2,803 million in the first half of 2024) and Clavam 625 (sales of Rs 2,657 million in the first half of 2024), stating that the batches in question are not-of-standard quality. The company emphasised its commitment to quality and patient safety, asserting that all its products adhere to current good manufacturing practices (cGMP).

"In its investigation, Alkem compared the CDSCO’s samples with its actual product batches and found significant differences in physical appearance, color, and labeling. The company has submitted a response to the CDSCO, including an assessment report confirming that the samples collected are indeed spurious and not manufactured by Alkem," the company claimed.

CDSCO inspectors regularly collect samples from medicines sold in the domestic market, issuing alerts on its website after testing them in competent laboratories. While the regulator’s findings are factual, it is crucial for both the industry and the regulator to address these issues effectively to protect public health.

Modern times require Modern Solutions

For modern times an ideal prescription should be a computerized printed form prescription so that it is legible opposite to oftenly an illegible physician's handwritten prescription. So that automization of dispensing of prescription medicines is possible by using modern technology like a computer scanner attached to pharmacy vending machines eg Script Pro Unit Dispenser.

The Need for Strict Action Against Companies Manufacturing Spurious Medicines in India.

The Need for Strict Action Against Companies Manufacturing Spurious Medicines

in India

by Vikas Parashram Meshram

spurious medicines

The news that 53 medicines claiming to relieve ailments such as fever, pain, high blood pressure, diabetes, etc., have failed to meet quality standards during trials is concerning. The inclusion of Paracetamol, a widely used medicine in the country, among these is ironic. It is astonishing that these medicines are being sold openly under the nose of the government. The Central Drug Regulator has released a list of medicines that do not meet quality standards. The general public is left wondering how these substandard drugs affect our health. Moreover, has any action been taken against those selling inferior medicines? As of now, no official information has been released in this regard. Undoubtedly, this is shameful and exposes the failure of the system, where the medicines people buy to alleviate physical suffering are substandard. It is highly likely that such inferior medicines could also have negative consequences. Serious research is needed in this regard.

Importantly, the medicine Paracetamol, which is commonly taken by people, also failed in the trials. It is generally believed that this medicine is effective in treating occasional fevers, pains, etc. Including it in the Central Drug Regulator’s list of substandard medicines will undoubtedly break people’s trust. It is unfortunate that human values have declined to the extent that people do not hesitate to play with the lives of suffering patients for their own benefit.

Although the CDSCO (Central Drugs Standard Control Organization) has tested the quality of 53 medicines, only a list of 48 was eventually released. The reason behind this is that five of the listed medicines were claimed by the manufacturing companies to be fake drugs being sold under their brand names. The unethical practices in the pharmaceutical industry are increasing the crisis in people’s lives. While the Drug Standard Control Organization has banned these medicines, today, these medicines are not saving millions of lives; instead, human greed is taking them.

Many branded companies’ medicines have also been included in the list of substandard and defective drugs. Despite strict processes in place to ensure the quality of medicines, cases of substandard medicines continue to surface. Even well-known pharmaceutical companies’ products are failing to meet the standards, leading one to believe that these companies have begun compromising ethics and humanity for more profits at lower costs. In addition to the issue of inferior drugs, many fake medicines are also being sold. These include medicines for BP, diabetes, acid reflux, and certain vitamins. Furthermore, among the medicines that have failed CDSCO’s quality standards are Paracetamol (a fever reducer), Diclofenac (a painkiller), and Fluconazole (an antifungal medicine), produced by some of the country’s largest pharmaceutical companies, which have also been declared harmful to health.

The release of a list of substandard medicines has raised concerns about the safety of patients’ health. Patients take medicine with the hope of recovery. Today, these medicines are not saving millions of lives; human greed is killing them. The inclusion of many branded companies’ medicines among substandard and defective drugs is alarming. Despite strict processes to ensure the quality of medicines, these cases of non-compliance with standards keep surfacing. The process includes testing raw materials and inspecting the production process. Even then, if well-known pharmaceutical companies’ products fail to meet the standards, it shows that they have begun to sacrifice ethics and humanity for more profits at lower costs.

This is not the first time medicines have failed to meet quality standards. The common public remains with the question: if these medicines do not meet the standards, what are their negative consequences? How much will these substandard medicines affect our health? Also, has any action been taken against those selling inferior medicines? Undoubtedly, this is shameful and highlights the failure of the system, where people buy medicines to reduce physical suffering, only to find them substandard. It is highly likely that such inferior medicines could have negative consequences, and serious research is needed in this regard. The ongoing sale of these medicines poses a threat to people’s health.

Meanwhile, the DSCO (Drugs Standards Control Organization) has granted exemptions for some medicines imported from select countries like the USA, Australia, Japan, Canada, and the European Union from routine sample testing. Yet, defects are being found in medicines from companies entering the Indian market. This will negatively affect our image. Any negligence in drug testing is inexcusable, as this malpractice in the pharmaceutical business could become a threat to people’s lives. The reality is that state governments are also delaying action against pharmaceutical companies run by the powerful and wealthy class, and it is the common people who are paying the price. It is unfortunate that human values have declined to such an extent that people do not hesitate to play with the lives of suffering patients for their own benefit.

This August, the central government banned the sale of 156 fixed-dose combination (FDC) medicines. In fact, these medicines were generally used in the form of cold and fever relief, pain relievers, multivitamins, and antibiotics. The production, distribution, and use of these medicines were banned because they were found to be harmful to patients. The government took this decision based on the recommendations of the Drug Technical Advisory Board, but medical quality remains questionable. In fact, the combination of several medicines into one pill is known as fixed-dose combination drugs (FDCs). However, the lack of standards in life-saving medicines used for common ailments is playing with patients’ lives.

The culprits selling inferior medicines must be severely punished. Such individuals are only interested in personal enrichment through wealth. Now, it seems that the times have become so absurd that anyone who gets the opportunity is involved in looting. The extent of this is evident when reports emerge of counterfeit injections being made instead of life-saving injections. We have become so greedy and inhumane that we have lost all sense of sensitivity, which is why we sell our dignity and mix Paracetamol into injections to sell them. What will all this wealth be worth? Pharmaceutical companies are jeopardizing people’s health by compromising on the quality of medicines. Firstly, there are no effective treatments for many diseases, and secondly, the essential medicines used for these diseases are unverified and defective. The government has failed to control this situation.

Millions of people across the country are looking to the administration for a way out. It seems that the government’s control over the system is weakening. Where will the common man go? The country that once gave the world a message of nobility, morality, and humanity now stands on the verge of moral collapse. Today, the country is so hollow and frail in terms of values and sensitivity. Materialistic and selfish values have taken root so deeply that eradicating them will not be easy. The entire conduct of man has become corrupt. Immorality has infiltrated all small and large businesses. In such circumstances, governments will have to formulate long-term policies, considering the broader implications. The regulatory departments must be held accountable, and those guilty of selling substandard medicines must be punished.

#PharmacistAndHisCertificate

#PharmacistAndHisCertificate 

A Pharmacist and his Certificate are not two different separable instruments to be left and move on...

One has no value without the other just as one side printed currency note.

A Pharmacist who doesnt know the professional value of his Certificate is not a Pharmacist.

POV : Bhagwan PS

DCC asks sub-committee to look into procedures related to disposal of unused medicines by general public

DCC asks sub-committee to look into procedures related to disposal of unused medicines by general public

Gireesh Babu, New Delhi

Monday, September 30, 2024, 08:00 Hrs  [IST]

The Drugs Consultative Committee (DCC) has asked the sub-committee which prepared a draft guidance document on safe disposal of unused or expired medicines, to look into the procedures related to disposal of such medicines by the general public.

The DCC, in its 64th meeting held on June 19, 2024, said that the sub-committee it recommended in the 58th meeting in July, 2020, has submitted its report along with the guidance document on safe disposal of unused/expired medicine now and the DCC deliberated the guidelines and report in detail.

"The DCC agreed in principle with the report of the sub-committee and the guidance document and recommended that the sub-committee may also look into the procedures mentioned under the draft guidance document related to disposal of expired/unused medicine by the general public before finalisation," said the Committee.

The 58th DCC meeting considered the proposal for creation of drug disposal policy for public and support for "pharm ecovigilance", following a letter received from All India Institute of Medical Sciences (AIIMS) referring an article that contains a study aimed to assess the extent of exposure of active pharmaceutical compounds (APCs) in the hydrologic cycle in and around New Delhi.

The study analysed the presence of 28 drugs from different classes in the surface water. The study further revealed that apart from therapeutic usage, the main source of ecological exposure could be due to the disposal of unused and expired pharmaceutical compounds into landfills. It revealed the existence of antimicrobial agents and other APCs in the aquifers of Delhi with levels >0.1µg/L.

Placement of appropriate strategies is expected to reduce the

burden of APCs and other pollutants into the hydrologic cycle. It has also been stated that un-segregated drug disposal could be a reason for the emergence of drug resistance with special reference to antibiotics.

"Hence, drug disposal policy for public and hospitals where people can dispose of used, unused, expired drugs and drug formulation safely is required," observed the committee in 2020, while recommending the constitution of a sub-committee under chairmanship of State Drugs Controller, Kerala to examine the issue.

The Indian Pharmaceutical Association (IPA), has also raised the issue with the then health minister J P Nadda in January, 2019, requesting development of strict regulations and policies for disposal of pharmaceuticals.

With no system in place to direct the patients and clinics to send the medicines unused through a specified safe collection and disposal mechanism, such medicines usually are dumped in the trash cans or flushed down the sink or toilet. In addition to medicines, blood sugar testing strips, cotton and bandage materials as well as syringes and needles used for self-injection, for example, of insulin by the patient are also dumped in the trash cans, said the IPA in a letter to the then health minister.

"All medicines are chemicals and their improper disposal poses a serious threat to the environment and public health," said the letter signed by general secretary of IPA, Suresh Khanna.

"Each year there are tons of expired or unused medicines disposed of by households, hospitals, and manufacturers. The disposal of these medicines is not as per any particular guideline and these disposed of medicines ultimately enter water resources such as rivers and lakes through soil and landfills, eventually affecting aquatic life and entering the food cycle through fish and vegetables. Improperly disposed medicines could also get repacked and recycled to pose a direct threat to human health," it added.

The Association suggested steps on a war footing including policies and systems for segregation, collection and disposal of pharmaceuticals at the domestic as well as at specific stages of the pharmaceuticals distribution chain, monitoring of large scale disposal of unused pharmaceuticals by the manufacturers, development of nation-wide awareness on the ill effects of unsafe and inappropriate disposal of pharmaceuticals, and mechanisms to reduce unnecessary medicine purchases and implementation of responsible use of medicine.

The Association also suggested development of the concept of eco pharmacovigilance and strict implementation. The collection and safe disposal system for unused expired or unexpired medicines must be developed and implemented at the local government level, it added.

We hope that the guidance note will provide detailed procedures for the collection, storage, transportation, and disposal of such drugs, ensuring they are managed in a way to protect the environment and public health.