The government of Punjab has conditioned the cardiac disposables and consumables products only FDA-approved and disqualified a majority of the European, Chinese, and Japanese brands cardiac suppliers also approved by the Drug Regulatory Authority Pakistan (DRAP).
According to a recent tender document of the Specialized Healthcare and Medical Education Department Government of the Punjab, the provincial government has sought invitation bids from interested parties having the ability to supply FDA-approved disposables and consumables required during the treatment of heart-related surgeries in the public hospitals of Punjab.
According to other DRAP-approved cardiac suppliers, the Punjab government’s recent centralised tender conditioning of FDA-only products would not only disqualify a majority of DRAP-approved suppliers for cardiology supplies but has ignited controversy. The decision has also raised serious concerns over fair competition and equal opportunity.
The DRAP, established under the DRAP Act, 2012, serves as a regulatory body ensuring stringent quality standards for healthcare products in Pakistan. However, despite DRAP approval, government of Punjab’s condition to require US FDA approval only, creating a dispute over procurement practices.
Total proposed budget of the tender is Rs15 billion based on the tender estimate price, which is likely to go to Rs18-20 billion. Out of this budget, Rs12 billion will be awarded to FDA brands and the remaining budget will be for the rest of the companies including CE and FDA both.
There is a serious price difference between the US brands and other brands. For instance, Balloon Catheter FDA Brands prices range between Rs14,500-17,000 as other CE Marked Drap Registered products range between Rs9,000-10,000. So only this product can eat extra budget of Rs400 million let alone other products such as guide wire and stents where numbers can go far beyond, while this extra amount can be spent on the treatment of other patients.
The recent move by the Specialized Healthcare Punjab to centralise tenders for cardiology supplies across seven major institutes, including the Punjab Institute of Cardiology and Multan Institute of Cardiology, has further exacerbated tensions.
Typically, tenders are issued individually by each hospital, allowing equal opportunities for participation. However, the centralised tender process has been criticised for its discriminatory pre-qualification and technical requirements that favour only a handful of companies.
Key grievances include the imposition of additional security deposits, with companies already having submitted bids and deposits for individual hospital tenders. The requirement for past experience specifically in Punjab-based teaching hospitals and the insistence on US FDA-approved products further limits competition and excludes new entrants from the bidding process.
Moreover, concerns have been raised about the transparency and fairness of the tender process, with allegations of malpractice and favouritism towards certain brands. The decision to disqualify other DRAP-approved suppliers in favour of US FDA-approved brands has sparked outrage among industry stakeholders, who view it as a deliberate attempt to monopolise the market and limit patient choice.
As the controversy continues to unfold, stakeholders urge the Punjab government to reconsider its tender policies and prioritise transparency, fairness, and healthcare accessibility.
When contacted, Dr Asim Javed, member committee of the Specialized Healthcare and Medical Education Department Government of Punjab, he said that the provincial government has taken this decision in the best interests of the patients, adding that cardiac-related issues are serious and the government aims to provide them the best medical care.
He further said that other suppliers are not disqualified as they can still provide other supplies, however, the government in the tender has conditioned some cardiac supplies with FDA approved. He rejected the notion that it would negatively affect the fair competition principle, saying there are five to six such suppliers.
He said that the decision has been taken after detailed deliberation keeping in view the welfare of the patients and suppliers will ensure required supplies.
This correspondent tried to contact Special Secretary Specialized Healthcare and Medical Education Department Government of Punjab and Dr Hafiz Shahzad Latif, additional secretary of the department by email and telephone but they did not respond.
Source: Business Recorder
#FDA #Punjab #Centralised #Controversy

$USDC
$SOL
$ETH

Elon Musk's Neuralink, a pioneering neurotechnology company, has been granted the green light by the FDA to initiate clinical trials involving brain chip implants. These innovative devices are designed to restore autonomy to individuals with unmet medical needs, particularly those suffering from paralysis due to spinal cord injuries or conditions like ALS.

PRIME Study - A Glimpse into Neuralink's Vision

Neuralink's "Precise Robotically Implanted Brain-Computer Interface" (PRIME) Study aims to evaluate the safety and functionality of its brain chip implants in paralyzed human volunteers. Under the FDA's investigational device exemption (IDE), this study represents a significant step towards creating a generalized brain interface, enabling individuals to control computers using their thoughts alone. The key component of this technology involves surgically embedding tiny flexible threads with electrodes in the brain region responsible for controlling movement.

Intricacies of Neuralink's Brain Implants

At the core of Neuralink's innovation lies the N1 Implant, a chip equipped with 1,024 electrodes thinner than a human hair. This implant records neural activity and measures approximately 8mm in diameter. The company envisions that once implanted, this device can read a user's intended hand and finger movements, translating them into commands to control external devices. While this approach is highly invasive, it holds the potential to restore mobility to paralyzed patients.

Balancing Hope and Ethical Concerns

Neuralink's journey has not been without controversy. The company faced criticism for botched animal experiments, resulting in over 1500 animal deaths. Beyond the technical challenges, the ethical dimension of brain implants that can read thoughts raises concerns about privacy and consent. The blurred line between treatment and human enhancement becomes evident, prompting a broader discussion on the ethics of such invasive technologies.

Future of Brain-Computer Interfaces

Neuralink's aspirations extend beyond medical applications. With recent funding of $280 million, the company envisions a future where AI-powered, thought-reading chips are commonplace and augment human capabilities. However, significant regulatory and ethical hurdles must be addressed before Elon Musk's vision can become a reality. As we explore the potential benefits and pitfalls of brain-computer interfaces, we must tread carefully into this uncharted territory, where science fiction meets medical innovation.

#ElonMusk #Neuralink #N1Implant #FDA #ArtificialIntelligence

Introduction

Neuralink, the brain-chip firm founded by visionary entrepreneur Elon Musk, has announced that it has obtained approval from the US Food and Drug Administration (FDA) to commence its first human tests. The company aims to revolutionize the field of neurotechnology by bridging the gap between brains and computers, with the ultimate goal of restoring vision and mobility to individuals. Although Neuralink does not currently have immediate plans for participant recruitment, this FDA approval marks a significant milestone in the company's journey towards developing groundbreaking treatments for paralysis, blindness, and enhanced human-computer interactions.

FDA Approval and Previous Challenges

Neuralink's journey to gain FDA approval has not been without hurdles. In a report published in March, Reuters cited safety concerns as the reason for the rejection of Neuralink's earlier bid for approval. However, the recent FDA approval signifies that the company has successfully addressed these safety concerns, paving the way for its human trials.

Neuralink's Vision and Objectives

Neuralink's microchips, which have been successfully tested in primates, are designed to decode brain signals and transmit information to external devices via Bluetooth. The company's primary objective is to utilize this technology to alleviate the challenges faced by individuals with disabilities, enabling them to regain mobility and enhance their interaction with computers and mobile devices. Furthermore, Elon Musk has previously highlighted the potential of Neuralink's brain-chip technology in addressing concerns about human displacement by artificial intelligence (AI).

Collaboration and Future Prospects

In a recent Twitter announcement, Neuralink expressed gratitude for the collaboration with the FDA and acknowledged the significant work accomplished by its team. While the company did not provide immediate details regarding participant recruitment, it assured the public that more information would be forthcoming soon. Neuralink emphasizes that safety, accessibility, and reliability are paramount considerations throughout the engineering process.

Technical and Ethical Challenges

Experts in the field have cautioned that Neuralink's brain implants will necessitate extensive testing to overcome technical and ethical challenges before they can be widely implemented. Ethical considerations regarding privacy, informed consent, and long-term effects on brain health must be carefully addressed. Additionally, the technical complexities of ensuring precise interpretation of brain signals and establishing robust communication with external devices pose significant obstacles that must be addressed to ensure the efficacy and safety of Neuralink's technology.

Neuralink's Progress in Context

While Neuralink has faced setbacks and timelines that were not met in the past, the recent FDA approval demonstrates the company's commitment to advancing neurotechnology. Founded by Elon Musk in 2016, Neuralink has attracted significant attention due to its ambitious goals and potential to transform the field of neuroscience. Although Neuralink's initial plan to implant chips in human brains in 2020 was delayed, the company remains determined to push the boundaries of technological innovation.

Recent Advancements and Inspiration

The FDA approval for Neuralink's human study comes in the wake of another groundbreaking development involving brain implants. Swiss researchers recently reported a successful case where a paralyzed individual from the Netherlands was able to walk by simply using his thoughts, thanks to a wireless system of implants that transmitted his neural signals to his legs and feet. These achievements highlight the immense potential of neurotechnology and underscore the importance of continued research and development in the field.

Closing Thought

Neuralink's receipt of FDA approval for human tests represents a significant step forward in realizing Elon Musk's vision of merging brains with computers to address mobility and vision-related challenges. Although there are significant technical and ethical challenges to overcome, Neuralink's progress underscores the potential of neurotechnology to transform the lives of individuals with disabilities. As the company moves forward with its human trials, the world eagerly awaits further advancements in this groundbreaking field. Neuralink's collaboration with the FDA demonstrates a commitment to ensuring the safety and efficacy of their brain-chip technology, which holds promise for revolutionizing the treatment of neurological conditions and enhancing human capabilities.

#FDA #Neuralink #human #ai