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The food and drugs commissioner confirmed that the FDCA would test these samples at certified laboratories, which are equipped with atomic absorption spectrometers. The authority found lead levels, which were 2, times higher than permissible limits given in Ayurvedic Pharmacopoeia of India API standards. The arsenic content in another set of medicines was found to be 1, times higher than the permissible limit.
Four of the six samples collected had failed the heavy metal tests according to FDCA. The federation also stated that the processed heavy metals and minerals are the backbone of the AYUSH www.
Federation further suggested that unethical actions on the part of State Government agencies have also shaken the faith of common man in AYUSH medicines.
In most of the modern world, including the United States, most Ayurvedic products are marketed without having been approved by the FDA. According to Indian government, every medicine whether synthetic or natural has a potential risk of causing health hazard, if it is not manufactured properly with assurance of quality, safety and efficacy and not consumed judiciously without adequate medical advice from a qualified medical practitioner of concerned system of medicine.
Schedule-E 1 of the Drugs and Cosmetics Rules, contains the list of 69 potentially hazardous substances of plant, mineral and animal origin including heavy metals.
Exclusive provisions exist in the Drugs and Cosmetics Act, and Rules there under for the licensing, manufacturing, labeling, shelf life and testing of these drugs. Does the government liability ends here by mandating manufacturers to put caution on the labels, or simply asking to voluntarily comply with the provisions of the above act.
Regulatory agencies also needs to step forward to actively regulate this industry and act proactively to preserve the trust and integrity of AYUSH medicines if government is serious of establishing AYUSH as an alternative to the modern medicine.
AYUSH manufacturers also bear some responsibilities to implement good manufacturing practices and quality controls so that their products are compliant with the regulatory www.
Healthcare providers and researchers practicing AYUSH system should take a lead to provide scientific evidences in support of their systems to gain public trust and to maintain the integrity of their profession.
Therefore, all stakeholders of AYUSH have equal responsibility to dispel such misconceptions with proactive measures and not being reactive to the articles or studies that are published now and then. Protecting population from heavy metal poisoning due to Ayurvedic remedies is certainly not an easy task, but, in the interest of public health, it is a task that all of its stakeholders must tackle with some urgency.
We were confident that the CMS would listen to candid feedback from the industry, so we did not slow the planning of our ACO. When the revised regulations were released in October and indeed addressed many of our concerns, we were far along with our ACO's planning and infrastructure development.
Some health care organizations, anticipating a decision that would have overturned the law, stopped planning for reform and innovation. Others took a wait-and-see attitude.
For our part, we did not believe that we should stop or even slow our plans for reform, as our system is unsustainable in its current condition. Regulations and laws can change quickly, but the pace of system reform can be glacial. When physicians in our region first learned about the ACO, many were skeptical about participating in an organized system of care, particularly one involving government.
Most understood that structural modifications were likely coming to our health care system, and they were unsure whether they wanted to be contributors to this change. Some feared lower income from decreased utilization of services; others were concerned about risk. In fact, the most important change in the final regulations from our perspective was that the CMS allowed health care professionals to enter the program with limited risk.
Sure enough, as physicians learned more about the ACO and its operating principles and governance structure, more joined. We learned that of the 27 approved ACOs that began operating on April 1, , ours was the second largest in the country, with approximately 50, attributed Medicare patients.
Each pod consists of a hospital, physicians, and other community-based organizations in the region. Together, these board members ensure appropriate community health care planning and coordination.
Care itself is coordinated by a network of clinical navigators who collaborate with primary care physician offices to identify patients with short-term and long-term care needs and guide them through planned pathways of care.
Case managers work with high—medical acuity patients who require intensive assistance with care planning. Clinical information is coordinated through a health information exchange, and medical records systems are integrated when possible.
Our ACO has now embarked on a systematic redesign of care. However, we have 16 other centers of high performance that incorporate multidisciplinary approaches to care management. Our participation in the Medicare Gain Sharing Program has helped identify ways to eliminate waste in our system, while our home care company's use of telemonitoring has provided lessons in utilizing technology to create greater efficiencies.
Overall, quality data with comparative benchmarking has been a long-standing part of our approach to advancing performance. We understand that solutions will require reductions throughout our cost structure as well as improvements in outcomes, service delivery, and access to care. The outcomes of our efforts will take a while to determine. For one thing, claims data from the CMS will lag behind.
For another, Medicare is having difficulty attributing patient data to specific health care professionals, making accountability for outcomes and costs a challenge. Shared savings distributions, if realized, are a good 18 months away.
That is a long time to hold the attention and loyalty of a large group of independent health care providers. Yet no matter the results of the cost data and quality metrics, we are confident that the ACO will be successful. How do we know?