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The Catastrophic Threat of Antimicrobial Resistance: A Tale of Neglect and Regulatory Lapses

In the intricate ecosystem of modern medical triumphs, antimicrobials stand as a monumental thread, weaving a fabric of hope and survival against microbial infections. However, this bastion of medical progress is under siege by a formidable adversary—antimicrobial resistance (AMR). AMR poses a dire and catastrophic threat to humanity, casting a long, ominous shadow over the future of global health. Among the myriad factors contributing to this perilous situation, a notable failure lies in the non-enforcement of the provisions of the Drug and Cosmetics Act of 1940 by the Drug Controller of India and the State Food and Drug Administrations (FDAs)/Drug Controllers.

The Alarming Rise of Antimicrobial Resistance

Antimicrobial resistance occurs when microorganisms such as bacteria, viruses, fungi, and parasites evolve to resist the drugs designed to kill them. This natural phenomenon is exacerbated by the misuse and overuse of antimicrobials in humans, animals, and agriculture. The World Health Organization (WHO) has declared AMR one of the top ten global public health threats facing humanity. The statistics are alarming: a 2019 study published in The Lancet estimated that AMR directly caused 1.27 million deaths globally, with another 4.95 million deaths associated with bacterial AMR .

In India, the situation is particularly dire. The country accounts for one of the highest burdens of bacterial infections in the world, and the prevalence of AMR is rising at an alarming rate. A 2020 report by the Indian Council of Medical Research (ICMR) highlighted that resistance to commonly used antibiotics like fluoroquinolones, cephalosporins, and carbapenems is increasing among pathogens such as *Escherichia coli*, *Klebsiella pneumoniae*, and *Acinetobacter baumannii*. These bacteria are responsible for severe infections, including urinary tract infections, pneumonia, and bloodstream infections .

The Drug and Cosmetics Act of 1940: A Neglected Guardian

Amidst the burgeoning crisis of antimicrobial resistance, the Drug and Cosmetics Act of 1940 was conceived as a vigilant guardian, a sentinel poised to protect the public health of India. This Act, meticulously crafted, sought to regulate the import, manufacture, distribution, and sale of drugs and cosmetics, ensuring their safety, efficacy, and quality. It bestowed upon the Drug Controller General of India (DCGI) and State Drug Controllers the authority to enforce its provisions, which include stringent regulations on the prescription and sale of antibiotics.

Central to these protective measures is the role of pharmacists, whose presence in pharmacies is mandated by law. Their duty in the battle against antimicrobial resistance is of paramount importance. Pharmacists are entrusted with the responsibility to verify the appropriateness of prescribed drugs, their dosages, and the legitimacy of the prescribing doctor. They must ascertain whether the prescribed medicines are necessary or merely pushed by doctors under the influence of pharmaceutical companies. Moreover, they counsel patients on the correct timing and duration of medication use, thereby playing a crucial role in preventing the misuse of antimicrobials and minimizing the risk of drug resistance.

In essence, pharmacists are required to audit prescriptions and advise patients to ensure that unnecessary use of antimicrobials is avoided, thus reducing the chances of drug resistance. Regrettably, in India, regulatory bodies often fail to ensure the consistent presence of pharmacists in pharmacies. This failure stands as the most significant factor contributing to the rampant rise of antimicrobial resistance in the country.

There are, however, notable exceptions to this pervasive neglect. The tenure of Mr. Mahesh Zagade as Commissioner of the FDA in Maharashtra from 2011 to 2014 serves as a beacon of what stringent enforcement can achieve. During his tenure, Zagade rigorously implemented the provisions of the Act, prioritizing patient safety and shielding the public from the malpractices of drug manufacturers and traders. His example illustrates that with proper enforcement of the law, the threat of drug resistance can indeed be tackled effectively.

This narrative underscores the critical need for rigorous regulatory oversight and the indispensable role of pharmacists in the fight against antimicrobial resistance. It is a clarion call to fortify our defenses, uphold the provisions of the Drug and Cosmetics Act, and ensure that every pharmacy in India serves as a bulwark against this looming health crisis.

Despite this robust legal framework, the enforcement of these provisions has been woefully inadequate. This regulatory failure has significantly contributed to the rampant misuse of antibiotics, a primary driver of AMR. Over-the-counter sales of antibiotics without prescriptions are commonplace, and counterfeit or substandard drugs are alarmingly prevalent in the market. The lack of stringent enforcement and oversight has created an environment where antibiotics are used indiscriminately, leading to increased resistance.

The Failure of Enforcement: A Case Study

Consider the case of a bustling city in India, where antibiotics can be purchased as easily as over-the-counter painkillers. Here, the Drug Controller’s office, under the purview of the Drug and Cosmetics Act, is tasked with regular inspections and crackdowns on unauthorized sales. However, due to a combination of bureaucratic inertia, lack of resources, and alleged corruption, these regulations are seldom enforced.

In 2021, an investigative report by a leading national newspaper revealed that in several states, including Uttar Pradesh, Maharashtra, and Tamil Nadu, antibiotics were being sold without prescriptions in more than 70% of surveyed pharmacies . This blatant disregard for the law not only undermines the fight against AMR but also endangers public health on a massive scale.

The Human Toll: Stories from the Frontlines

The impact of this regulatory failure is not merely statistical; it is profoundly human. In rural and urban hospitals alike, doctors face the harrowing task of treating infections with dwindling therapeutic options. Take the story of Rani, a 32-year-old mother from Uttar Pradesh. She was admitted to a local hospital with a severe urinary tract infection. Despite receiving multiple courses of antibiotics, her condition worsened. The doctors eventually identified the culprit: a multi-drug resistant strain of *Escherichia coli*, resistant to all first-line antibiotics.

Rani’s story is not unique. Across India, patients suffer prolonged illnesses, higher medical costs, and increased mortality due to antibiotic-resistant infections. The economic burden is staggering, with a 2017 report by the World Bank predicting that by 2050, AMR could result in a 3.8% reduction in global GDP and push an additional 28 million people into poverty .

The Path Forward: Urgent Reforms and Global Cooperation

To avert the looming catastrophe of AMR, urgent and coordinated action is required. Strengthening the enforcement of the Drug and Cosmetics Act of 1940 must be a top priority. This involves stringent implementation of the law by the DCGI and State FDAs, enhancing surveillance and monitoring systems, and implementing stricter penalties for violations.

Moreover, public awareness campaigns are crucial to educate the populace about the dangers of antibiotic misuse. Healthcare professionals must also be trained to prescribe antibiotics judiciously, adhering to evidence-based guidelines.

International collaboration is essential in this fight. India must engage with global partners to share data, research, and best practices. The WHO’s Global Action Plan on AMR provides a comprehensive framework for countries to develop and implement national action plans. India’s National Action Plan on AMR, launched in 2017, is a step in the right direction, but its success hinges on effective implementation and enforcement.

A Call to Action

The specter of antimicrobial resistance is a dire and catastrophic threat that demands immediate attention and decisive action. The failure to enforce the provisions of the Drug and Cosmetics Act of 1940 has significantly contributed to this crisis in India. However, it is not too late to reverse the tide. With concerted efforts from government authorities, healthcare professionals, and the public, we can fortify our defenses against AMR and safeguard the health of future generations. The time to act is now, for the stakes could not be higher.

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The Evolutionary Legacy and Modern Perils: The Onslaught of Sugar upon Human Health

Introduction:

The annals of human existence stretch back approximately 25 lakh years, a temporal odyssey wherein our kind navigated the currents of time, evolving in tandem with the natural milieu, adept at overcoming the challenges posed by the untamed wilderness. Central to this adaptive journey was the practice of consuming unprocessed sustenance, a behavior etched into our biological fabric through the intricate process of evolution. However, a seismic transformation unfurled over the past four millennia, as humanity shifted from a regimen of raw nourishment to an indulgence in refined victuals, notably sugar. This metamorphosis has birthed a health conundrum, with sugar emerging as a formidable adversary to human well-being. The origins of this quandary extend beyond individual choices to the very heart of our economic edifice, where an insatiable thirst for profit propels the dissemination of health hazards induced by sugar. Governments and medical practitioners, erstwhile guardians of public health, now find themselves relegated to mere spectators. Let us delve into the evolutionary trajectory of human nutrition, the repercussions of the sugar onslaught on health, and the socio-economic factors that sustain this crisis. It underscores the pressing need for corrective measures by food regulators, medical professionals, and influencers to forestall an irreversible course.

1. The Odyssey

The evolutionary chronicle of humankind spans millions of years, a saga marked by adaptation and tenacity in the face of environmental exigencies. At the heart of this adaptation lies the human diet, initially dominated by the consumption of uncooked sustenance. Nevertheless, the last approximately 4000 years have witnessed a departure from this evolutionary norm, with the advent of refined victuals, especially sugar, ushering in an epoch fraught with health risks. Let us scrutinize the evolutionary progression of human nutrition, the injurious effects of sugar consumption, and the complicity of market forces in perpetuating this crisis.

2. Evolutionary Foundations: Consumption of Raw Fare

The journey of human evolution is intricately interwoven with dietary adjustments. For around 25 lakh years, our forebears flourished in the wilderness, subsisting on unprocessed food sources. This prolonged era of consuming raw victuals played a pivotal role in shaping the human digestive system and metabolic processes. The abundance of fiber, essential nutrients, and enzymes in raw foods were crucial for the optimal functioning of the human body.

2.1. Biological Accommodations to Raw Nourishment

Evolutionary biology posits that the human digestive system adapted to the consumption of raw, fiber-rich foods such as fruits, vegetables, and lean meats. Natural selection favored individuals endowed with digestive enzymes proficient in breaking down raw foods, ensuring the absorption of vital nutrients and contributing to the robust health of our ancestors.

2.2. Nutritional Merits of Raw Food

Raw foods inherently abound in vitamins, minerals, and phytochemicals, fostering overall well-being and bolstering resistance to diseases. The absence of processing and cooking preserves the nutritional integrity of these foods, facilitating the absorption of essential nutrients by the human body. The proclivity for consuming raw food aligns with the nutritional requisites of our species, as evidenced by the robust health of hunter-gatherer societies.

3. The Sugar Revolution: A Modern Onslaught on Health

The advent of agriculture some 10,000 to 12,000 years ago marked a pivotal shift in human dietary practices. While the cultivation of grains and domestication of animals broadened the array of food options, it was the last 2500 years that witnessed the introduction of refined sugars, heralding a revolution in human nutrition. The first chemically refined sugar made its debut in India approximately 2,500 years ago. Subsequently, the technique traversed eastward towards China and westward towards Persia and the early Islamic worlds, ultimately reaching the Mediterranean in the 13th century. Cyprus and Sicily emerged as pivotal centers for sugar production. In the Middle Ages, sugar was deemed a rare and opulent spice, rather than an everyday condiment. Sugar, once a luxury reserved for the elite, has metamorphosed into a ubiquitous element in the modern diet, ushering in a cascade of health predicaments.

3.1. The Ascendance of Sugar Consumption

Historically, sugar was a scarce commodity, derived from sources like sugarcane and honey. Nonetheless, advancements in agriculture and trade democratized access to sugar, integrating it as a integral component of the average diet. The Industrial Revolution further expedited sugar production, resulting in its widespread availability and affordability.

3.2. Health Ramifications of Sugar Consumption

The shift from unprocessed to refined foods, particularly the surge in sugar consumption, has been linked to a myriad of health issues.

Sugar is often perceived as an innocuous indulgence, but recent research suggests its potential lethality surpassing that of a bullet. According to a study published in the Journal of the American Medical Association, excessive sugar intake escalates the risk of heart disease, stroke, and various other health maladies, positioning it as a leading cause of global mortality. The researchers posit that surpassing 25 grams of added sugar per day, roughly 6 teaspoons, significantly elevates the risk of health complications. This is a relatively modest amount, given that a solitary can of soda contains approximately 40 grams of sugar.

Excessive sugar intake is correlated with obesity, type 2 diabetes, cardiovascular ailments, and dental issues. The elevated fructose content in sugar contributes to metabolic dysfunction, detrimentally impacting liver health. Moreover, sugar consumption is implicated in the burgeoning prevalence of non-communicable diseases, presenting a substantial public health challenge. In 2019, diabetes directly caused 1.5 million deaths, with 48% occurring before the age of 70. An additional 460,000 kidney disease deaths were attributable to diabetes, and elevated blood glucose contributed to roughly 20% of cardiovascular deaths.

As per the WHO fact sheet, noncommunicable diseases (NCDs) stand as the primary cause of global mortality, accounting for 71% of all deaths. Within the WHO European Region, almost 90% of all deaths are attributed to NCD-related morbidity and mortality. An unhealthy diet ranks among the four principal behavioral risk factors for NCDs. Obesity, a malady in its own right, concurrently serves as a major risk factor for several NCDs, including cardiovascular diseases, type 2 diabetes, and certain cancers. Over 59% of adults and an escalating proportion of children in the Region grapple with overweight and obesity. The excessive intake of free sugars jeopardizes the nutritional quality of the diet, imparting substantial energy devoid of commensurate nutritional benefits, thereby fostering unhealthy weight gain and heightening the risk of overweight, obesity, and other NCDs. Moreover, excessive sugar intake precipitates dental caries and its attendant health ramifications.

Approximately 184,000 deaths annually can be attributed to the consumption of sugar-sweetened beverages (SSBs) globally. Epidemiological and decision models serve as indispensable tools for estimating the disease burden.

4. The Role of the Market Economy: Prioritizing Profits over Health

The exponential surge in sugar consumption is not a mere consequence of individual choices but is deeply entrenched in the fabric of our market economy. The food industry, propelled by an unquenchable thirst for profit, assumes a pivotal role in endorsing and perpetuating the sugar-laden diet. The market’s fixation on inexpensive, processed foods

laden with sugars and additives reflects a disregard for public health in the relentless pursuit of financial gain.

4.1. Profit-Centric Practices of the Food Industry

The food industry strategically employs marketing, product innovation, and flavor manipulation to craft addictive and palatable products. Highly processed foods, replete with sugars and synthetic additives, inundate the market, captivating consumers and contributing to the global health crisis. The profit-centric model prioritizes shelf stability, taste, and convenience over nutritional value, exacerbating the prevalence of health hazards induced by sugar.

4.2. Government and Medical Inertia

Governments and medical professionals, entrusted with the guardianship of public health, have largely assumed a passive stance in the face of the sugar epidemic. Regulatory frameworks frequently lag behind the swift evolution of the food industry, permitting the unhindered proliferation of sugary products. The medical community, while cognizant of the health risks associated with sugar, is often constricted by systemic factors that curtail their capacity to effect meaningful change.

5. The Sugar Menace: Surpassing Tobacco

The gravity of the sugar-induced health crisis is exemplified by its outstripping of tobacco as a primary cause of preventable diseases and fatalities. While the detrimental effects of tobacco have undergone extensive scrutiny and ameliorative efforts, the sugar epidemic continues to escalate, exacting a toll greater than any other dietary malefactor. The addictive allure of sugar, coupled with its omnipresence in processed foods, amplifies the severity of the crisis.

5.1. Comparative Examination: Sugar vs. Tobacco

Studies posit that excessive sugar consumption is a significant contributor to obesity, diabetes, and cardiovascular diseases, collectively surpassing the health burden imposed by tobacco use. The accessibility and societal acceptance of sugary products further contribute to the pervasive nature of this health crisis. Despite mounting evidence linking sugar to chronic diseases, public awareness remains inadequate, exacerbating the challenge.

6. The Nexus of Sugar, Pharmaceuticals, and Healthcare Profits

The sugar epidemic not only bestows lucrative profits upon the food industry but also provides opportunities for the pharmaceutical and healthcare sectors to capitalize on resultant health crises. The surge in chronic diseases linked to sugar consumption fuels the demand for pharmaceutical interventions and medical treatments. This symbiotic relationship between the sugar-laden diet, healthcare costs, and pharmaceutical profits underscores the multifaceted nature of the crisis.

6.1. The Role of the Pharmaceutical Industry

The pharmaceutical industry, positioned to address the health consequences of sugar consumption, stands to benefit from the perpetuation of the crisis. Medications designed to manage diabetes, cardiovascular diseases, and obesity become indispensable components of treatment plans, contributing to the economic growth of the pharmaceutical sector. This economic interdependence raises ethical questions regarding the motivations behind addressing the root causes of the sugar epidemic.

6.2. Healthcare Profits and Sugar-Related Maladies

As the prevalence of sugar-related diseases escalates, healthcare systems witness a surge in the demand for medical services. Doctors, in turn, experience a rise in patient visits and treatments, translating into financial gains. While healthcare professionals play a pivotal role in managing the health consequences of sugar consumption, the economic incentives associated with treating rather than preventing these conditions raise concerns about the prioritization of profit over public health.

7. The Call for Course Correction: A Collective Responsibility

The escalating sugar-induced health crisis demands a collective and expeditious response from food regulators, medical practitioners, and social influencers. Governments must enact stringent regulations to curb the marketing and production of sugary products, prioritizing public health over corporate interests. Medical professionals should engage in proactive education and advocacy, empowering the public to make informed dietary choices.

7.1. Regulatory Revisions

Regulatory bodies must evolve to keep pace with the dynamic nature of the food industry. Stringent labeling requirements, restrictions on marketing to vulnerable populations, and taxation on sugary products can serve as efficacious measures to curb excessive sugar consumption. Collaborative efforts between governments, health organizations, and the food industry are essential to institute comprehensive regulatory reforms.

7.2. Medical Advocacy and Education

Medical professionals, as trusted repositories of health information, must actively engage in public education regarding the risks of excessive sugar consumption. Integrating nutritional education into medical curricula and incorporating dietary counseling into routine patient care can empower individuals to make healthier choices. Additionally, healthcare providers should advocate for policy changes that prioritize preventive measures over reactive treatments.

7.3. The Role of Social Influencers

In the digital era, social influencers wield considerable sway over public opinions and behaviors. Collaborations between health organizations and influencers can leverage social media platforms to disseminate accurate information about the health consequences of sugar consumption. By fostering a culture of wellness and promoting responsible dietary choices, influencers can contribute to a societal shift away from the current sugar-laden norm.

A Clarion Call for Humanity

The assault of sugar on human health is a multifaceted crisis rooted in the intersection of evolutionary biology, market forces, and societal choices. The deviation from the consumption of raw food to the contemporary sugar-laden diet represents a departure from our evolutionary heritage, with profound implications for public health. Governments, medical professionals, and social influencers must unite in a concerted effort to address the root causes of the sugar epidemic, steering humanity away from the precipice of irreparable damage. The time for action is now, as the consequences of inaction threaten to exacerbate the crisis to a point of no return. The wake-up call for humanity is clear – a collective commitment to prioritizing health over profit is imperative to secure a healthier and sustainable future for generations to come.

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I will do all to safeguard public, says Mahesh Zagade

MUMBAI 7-MIN READ

The Maharashtra FDA Commissioner insists every chemist shop must have a qualified pharmacist, finds Dilip Chaware.

Reported By: Dilip Chaware | Source: DNA | Updated: Nov 27, 2013, 11:00 AM IST 

Are we aware that Adverse Drug Reaction (ADR) claims about 1,00,000 lives in the US every year or that no precautions in this regard are taken in India as a whole to prevent ADR?

Do we check if a pharmacist is present in our chemist shop? Do you insist on obtaining a bill after buying a medicine?

Absence of pharmacists during the crucial step of sale of medicines can have a very serious impact on not just the current generation, but even the generations to come. The business of medicine is different from other businesses; here, one is dealing with the patient who is already in a vulnerable condition. As such, utmost care should be taken to ensure that his health is not further compromised by wrongly sold or prescribed medicine.https://7065c2fe1e4568980574e1252ae72db8.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html

These are some of the elementary provisions in various laws enacted in India for safeguarding the average consumer but few care to observe them. Unless the general public is more vigilant in implementing laws, the situation would not improve, Mahesh Zagade, Commissioner of Food And Drug Administration (FDA), Maharashtra says.

When Maharashtra FDA Commissioner Mahesh Zagade began enforcing various legal provisions in different existing legislations, he had to face stiff opposition from all quarters. An agitation was launched against him by chemists’ associations. The agitation is still going on in bits and pieces. Fortunately, Zagade has been able to implement the campaign relentlessly since he believes that a patient’s life is more precious than any business or commercial consideration.

He is happy that the drugs and pharmaceutical industry, by and large, has responded positively to his crusade.https://7065c2fe1e4568980574e1252ae72db8.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html

Maharashtra has about 51,000 chemist shops. That works out to one shop for every 2,000 people, on an average. The state has 150 drug inspectors. Zagadediscovered at the beginning of his tenure that almost 34 percent of the chemist shops had been carrying out business without appointing a qualified pharmacist. Following this and with the cooperation from the retailers, he ordered that each shop must be inspected at least once a year by an inspector. He also started cancelling licenses. No such step was ever taken in the past. As a result of this intensive drive, appointment of pharmacists has received a much-needed boost all over the State. The outcome is that Maharashtra leads in the country as far as inspection of chemist shops is concerned.

As if by a coincidence, Zagade took over the reins of Maharashtra FDA in August 2011 when the Food Safety & Standards Act (FSSA) came to be enforced across the country. FSSA replaced the antiquated Prevention of Food Adulteration Act, 1954. Zagade was determined to enforce the provisions of FSSA in letter and spirit. Over the past two years, he has faced many hurdles but is glad to declare that his efforts are proceeding in the right direction and the general awareness about consumption of medicines is on the rise.

“At the end of the day, what matters is the safety of the people. I want Maharashtra FDA to emerge as a department that cares for the people, guards then from unscrupulous elements. Public good must prevail over private interests,” Zagade explained in an interview for a special feature on FDA Maharashtra.

At a meeting of the All India Drugs Consultative Committee held in New Delhi on November 12, 2013, Zagade circulated a note which bluntly brought home the truth that various provisions relating to the food items and medicines were observed more in breach than in implementation (See Pg 10 for the note). Zagade’s submission changed the complexion of the meeting agenda and it was agreed generally that all state FDAs needed to be more proactive in safeguarding the citizens of the country from the spread of spurious drugs, adulterated food items and from those professing magic remedies.

The sex ratio in Maharashtra has improved dramatically over the past two years. Ranked lowest in the state for its skewed child sex ratio in 2011, for instance, Beed district is now showing a promising upward swing, having recorded a 159-point jump last year in the number of baby girls born per 1,000 boys. The state’s child sex ratio at birth, too, has shown at upward turn, with 905 baby girl births recorded for every 1000 boys last year, a feat officials attribute to the effective implementation of the PCPNDT Act.  When asked if his campaign against unethical medical practices has contributed to this achievement, Zagade says, “I can only say that sales of certain MTP (medical termination of pregnancy) drugs have dropped by 87 per cent in Maharashtra over the past two years. It is for the authorities to determine how FDA’s role has promoted in creating awareness in this regard.”

Attributing his achievements to the dictum “Implement law as it is, schemes as they are,” Zagade describes how he had to wage a battle inside the FDA and outside for such implementation. “One flaw I noticed in the mechanism after taking over was that the average patient was nowhere while the focus was restricted to the manufacturer, distributor and seller. I was determined to shift the focus to the common man. I am happy to claim that I have been successful to some degree though much remains to be done.”

A milestone in Zagade’s two-year tenure is his effort in smashing the stranglehold of the chemists’ association. Industry insiders know very well how the association dictated terms to manufacturers, distributors and retailers. A system of obtaining a No Objection Certificate (NOC) from the association for introduction of a new medicine in the market and to appoint a dealer and stockist, though it had no legal standing. The manufacturers were required to obtain such an NOC without which business could not be run. Zagade raised his voice against this extra-constitutional practice. The matter went to the Competition Commission of India. Finally, the association had to issue an official circular which stated that no NOC from it would be required and that there would be no boycott of pharma companies that did not approach the association for an NOC.

To guard the average consumer further, Zagade appointed a committee to recommend guidelines on how to issue prescriptions. The committee comprises representatives of prominent Council and those practicing Ayurveda or Unani systems, and of the Pharmacy Council.

Another important enforcement is that no drug would be sold by a chemist shop without issuing a bill. The precaution is needed to prevent the sale of spurious drugs and to establish traceability of every transaction. “I found that hardly 5 to 6 per cent transactions were billed,” he reveals. An agitation is underway against this enforcement, too, but Zagade is unruffled.

Zagade declares that Maharashtra is the topmost state in implementing provisions of FSSA, which covers all stages of food, from the moment raw materials leave an agriculturists stock until it reaches the dining table. It is from ‘Farm to Fork,’ he remarks. Transport of raw material, its stocks in godowns, suppliers, processors, manufacturers, tistributors and retailers are all under the purview of the Act. FDA is the sole implementing authority in this chain. There is a food management system and filing of annual returns with specific periodicity is mandatory.

Self-compliance for testing and food auditing also forms part of this mechanism. “Strict implementation of FSSA will ensure that no consumer receives sub-standard or outdated food items,” Zagade points out.

About the stellar performance of Maharashtra FDA in implementing FSSA, Zagade says that out of the 16 lakh licenses issued under FSSA in the country, Maharashtra’s share is about 4 lakh or almost 25 per cent. In banning harmful products like gutkha or scented supari, the seizures all over the country amount to less than Rs10 crore whereas Maharashtra alone has confiscated such products worth Rs24 crore. “This shows how serious Maharashtra FDA is about the well-being of the average citizen. Maharashtra tops in almost all health parameters in the food or drug sector.”

To make the system of analysing health and medicinal products still more stringent, Zagade has asked the FDA laboratory to come out with its report within three days of submitting a sample.

Earlier, several months used to elapse before such a report was available. Moreover, Zagade has created a system whereby the chemical analyser will inform all the drug inspectors in the state, all the FDA Commissioners around the country and the media about the findings through a single email at the same time. “This will alert the machinery and the general public will be informed through the media about the products which are recalled from the market,” he points out.

Zagade, who joined the IAS in 1993, has taken on the mighty and the powerful at every post he has been appointed to. He has faced slander campaigns and has been threatened with fatal assaults. But he is determined to decimate unscruplous elements and practices.

About the challenges he faces in the present assignment, Zagade says, “I am trying to change the mindset of the FDA machinery so that even after my transfer, the campaign continues. I want the FDA to play a role in which it protects the people from wrongdoers. I am of the opinion that ultimately, it is the general public which has to be vigilant and alert towards protecting its own rights.”

Maharashtra has about 51,000 chemist shops and 150 drug inspectors. Almost 34 per cent of the chemist shops had been carrying out business without appointing a qualified pharmacist. The situation is changing for the better since Zagade has taken over.

An MNC sold a product which was already banned in the US and misrepresented about the ban. Maharashtra FDA was quick to expose this racket.

A committee to recommend guidelines on how to issue prescriptions consists of expert representatives from all branches of medicine. The committee’s report is expected to be submitted soon.

Out of the 16 lakh licenses issued under FSSA in the country, Maharashtra’s share is about 4 lakh. In banning harmful products like gutkha or scented supari, the seizures all over the country amount to under Rs.10 crore whereas Maharashtra has confiscated such products worth Rs.24 crore.

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