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FDA Only ProductsThe 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

FDA Only Products

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

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Is Elon Musk's Neuralink Ushering in the New Era of Brain-Computer Interfaces?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

Is Elon Musk's Neuralink Ushering in the New Era of Brain-Computer Interfaces?

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
🚨 #ElonMusk Neuralink receives #FDA approval to launch an in-human brain chip ⚡We have only one question... Will we be able to insert a #ChatGPT. extension on that brain chip? 🤔😂
🚨 #ElonMusk Neuralink receives #FDA approval to launch an in-human brain chip

⚡We have only one question... Will we be able to insert a #ChatGPT. extension on that brain chip? 🤔😂
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