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FMCS Certification Consultants: Your Guide to Global Market Access
In today's global marketplace, businesses must follow a variety of regulatory standards to assure product quality and compliance. FMCS (international Manufacturer accreditation Scheme) accreditation is one of the mandatory requirements for international manufacturers who want to sell their products to India. At Fusion Compliance Services, we specialize in offering expert FMCS certification consulting, helping businesses streamline the certification process and gain smooth access to the Indian market.
What is FMCS Certification?
FMCS (Foreign Manufacturer Certification Scheme) is a certification program introduced by the Bureau of Indian Standards (BIS). It mandates that foreign manufacturers comply with Indian standards before their products can be sold in the Indian market. This certification applies to a wide range of products, including electronics, appliances, textiles, and food products, ensuring they meet India’s quality and safety standards.
The FMCS certification is a mark of trust and quality, demonstrating that a product is safe for consumers and adheres to Indian regulatory requirements. For foreign manufacturers, securing FMCS certification is essential to ensure their products can be imported and sold legally in India without regulatory hurdles.
The FMCS Certification Process
The FMCS certification process consists of several important processes that require organizations to follow particular rules established by the BIS. Fusion Compliance Services offers end-to-end assistance to guarantee that the process runs smoothly and efficiently. Here's an overview of the normal FMCS certification process:
Product Testing: The product must undergo testing in a BIS-recognized laboratory to ensure it meets Indian standards. Fusion Compliance Services assists manufacturers in selecting accredited laboratories and preparing the product for testing.
Documentation: Accurate and thorough documentation is essential for FMCS certification. We help manufacturers prepare all required documents, including product details, manufacturing information, and technical specifications.
BIS Inspection: Once the documents are submitted, the Bureau of Indian Standards conducts an inspection of the manufacturing facility to verify compliance with Indian standards. Fusion Compliance Services coordinates with the BIS and guides manufacturers in preparing for the inspection.
Approval and Certification: After a successful inspection and review of the documents, the BIS issues the FMCS certificate, authorizing the foreign manufacturer to sell their products in the Indian market.
Why FMCS Certification Matters
FMCS accreditation is crucial for international firms seeking to establish a presence in India. It assures that their products fulfill local safety, quality, and performance requirements. Without this certification, products may face import restrictions, resulting in delays or penalties.
FMCS accreditation assures Indian consumers that the things they purchase from abroad producers satisfy the same stringent standards as those manufactured domestically.
How Fusion Compliance Services Can Help
At Fusion Compliance Services, we are dedicated to helping businesses navigate the complex FMCS certification process. With over 20 years of experience in compliance consulting, our team of experts understands the nuances of Indian regulatory standards and can provide tailored solutions for your certification needs.
Our FMCS Certification Services Include:
Guidance on product testing: We help manufacturers select the right BIS-accredited laboratories and ensure that products meet the necessary standards before testing.
Comprehensive documentation support: Our experts assist in preparing and submitting all required documents, ensuring accuracy and completeness.
BIS inspection preparation: We work together with your team to guarantee that your production plant is ready for BIS inspection, reducing the risk of delays or rejections.
Post-certification support: Even after the certification is granted, we offer ongoing support to help you maintain compliance and address any future regulatory changes.
Why Choose Fusion Compliance Services?
At Fusion Compliance Services, we pride ourselves on delivering high-quality, client-centric solutions. Our experienced team is dedicated to helping foreign manufacturers achieve FMCS certification with ease, ensuring timely market access and regulatory compliance.
Key Advantages of Working with Us:
Experienced Team: Our team of multidisciplinary engineers and compliance consultants brings extensive expertise in Indian regulatory standards.
Cost-Effective Solutions: We offer competitive pricing for our services, ensuring that FMCS certification is accessible and affordable.
Customer Satisfaction: With over 2,400 happy clients and 270 successful projects, we are committed to providing exceptional service and ensuring client satisfaction.
Contact Us Today!
For all your FMCS certification needs, contact Fusion Compliance Services at:
Office Address: Office no. S1 520, Cloud-9, Vaishali Sector 1, Near Mahagun Metro Mall, Ghaziabad, Uttar Pradesh-201012
Phone: +91-9696966665
Email: [email protected]
Let Fusion Compliance Services assist you in achieving hassle-free FMCS certification and confidently expanding your business in the Indian market.
#FMCS Certification Experts#FMCS Compliance Consultants#FMCS Certification Services#FMCS Certification Specialists#FMCS Certification Process Guidance#Trusted FMCS Consultants#FMCS Certification Assistance#FMCS Compliance Solutions#FMCS Certification in India#FMCS Regulatory Consultants
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2022 Update CCNP Security 300-710 SNCF Dumps
The latest CCNP Security 300-710 SNCF Dumps are new updated for your Securing Networks with Cisco Firepower exam. PassQuestion provides you the latest 300-710 questions and answers to help you attempt a real exam so you can achieve the best results. With our CCNP Security 300-710 SNCF Dumps, you can be rest assured that you will Pass your Cisco 300-710 Exam on Your First Try. It will also save your valuable time. We recommend you to go through the CCNP Security 300-710 SNCF Dumps several times so you can pass the Cisco 300-710 exam on the first attempt. It is the right way to attempt a real exam so you can achieve the best results.
300-710 SNCF Exam Description - Securing Networks with Cisco Firepower
The Securing Networks with Cisco Firepower v1.0 (SNCF 300-710) exam is a 90-minute exam associated with the CCNP Security, and Cisco Certified Specialist - Network Security Firepower certifications. This exam tests a candidate's knowledge of Cisco Firepower�� Threat Defense and Firepower®, including policy configurations, integrations, deployments, management and troubleshooting.
Cisco 300-710 Exam Overview:
Exam Name: Securing Networks with Cisco Firepower Exam Number: 300-710 SNCF Exam Price: $300 USD Duration: 90 minutes Number of Questions: 55-65 Passing Score: Variable (750-850/1000 Approx.)
300-710 SNCF Exam Topics Included :Deployment (30%)
1.1 Implement NGFW modes 1.1.a Routed mode 1.1.b Transparent mode 1.2 Implement NGIPS modes 1.2.a Passive 1.2.b Inline 1.3 Implement high availability options 1.3.a Link redundancy 1.3.b Active/standby failover 1.3.c Multi-instance 1.4 Describe IRB configurations
Configuration (30%)
2.1 Configure system settings in Cisco Firepower Management Center 2.2 Configure these policies in Cisco Firepower Management Center 2.2.a Access control 2.2.b Intrusion 2.2.c Malware and file 2.2.d DNS 2.2.e Identity 2.2.f SSL 2.2.g Prefilter 2.3 Configure these features using Cisco Firepower Management Center 2.3.a Network discovery 2.3.b Application detectors (Open AppID) 2.3.c Correlation 2.3.d Actions 2.4 Configure objects using Firepower Management Center 2.4.a Object Management 2.4.b Intrusion Rules 2.5 Configure devices using Firepower Management Center 2.5.a Device Management 2.5.b NAT 2.5.c VPN 2.5.d QoS 2.5.e Platform Settings 2.5.f Certificates
Management and Troubleshooting (25%)
3.1 Troubleshoot with FMC CLI and GUI 3.2 Configure dashboards and reporting in FMC 3.3 Troubleshoot using packet capture procedures 3.4 Analyze risk and standard reports
Integration (15%)
4.1 Configure Cisco AMP for Networks in Firepower Management Center 4.2 Configure Cisco AMP for Endpoints in Firepower Management Center 4.3 Implement Threat Intelligence Director for third-party security intelligence feeds 4.4 Describe using Cisco Threat Response for security investigations 4.5 Describe Cisco FMC PxGrid Integration with Cisco Identify Services Engine (ISE) 4.6 Describe Rapid Threat Containment (RTC) functionality within Firepower Management Center
View Online Securing Networks with Cisco Firepower 300-710 Questions and Answers
1.Which interface type allows packets to be dropped? A. passive B. inline C. ERSPAN D. TAP Answer: B
2.An engineer is building a new access control policy using Cisco FMC. The policy must inspect a unique IPS policy as well as log rule matching. Which action must be taken to meet these requirements? A. Configure an IPS policy and enable per-rule logging. B. Disable the default IPS policy and enable global logging. C. Configure an IPS policy and enable global logging. D. Disable the default IPS policy and enable per-rule logging. Answer: C
3.On the advanced tab under inline set properties, which allows interfaces to emulate a passive interface? A. transparent inline mode B. TAP mode C. strict TCP enforcement D. propagate link state Answer: D
4.A Cisco FTD has two physical interfaces assigned to a BVI. Each interface is connected to a different VLAN on the same switch. Which firewall mode is the Cisco FTD set up to support? A. active/active failover B. transparent C. routed D. high availability clustering Answer: C
5.An organization is migrating their Cisco ASA devices running in multicontext mode to Cisco FTD devices. Which action must be taken to ensure that each context on the Cisco ASA is logically separated in the Cisco FTD devices? A. Add a native instance to distribute traffic to each Cisco FTD context. B. Add the Cisco FTD device to the Cisco ASA port channels. C. Configure a container instance in the Cisco FTD for each context in the Cisco ASA. D. Configure the Cisco FTD to use port channels spanning multiple networks. Answer: C
6.An engineer is configuring a Cisco IPS to protect the network and wants to test a policy before deploying it. A copy of each incoming packet needs to be monitored while traffic flow remains constant. Which IPS mode should be implemented to meet these requirements? A. Inline tap B. passive C. transparent D. routed Answer: A
7.Which two dynamic routing protocols are supported in Firepower Threat Defense without using FlexConfig? (Choose two.) A. EIGRP B. OSPF C. static routing D. IS-IS E. BGP Answer: B,E
8.An engineer must configure high availability for the Cisco Firepower devices. The current network topology does not allow for two devices to pass traffic concurrently. How must the devices be implemented in this environment? A. in active/active mode B. in a cluster span EtherChannel C. in active/passive mode D. in cluster interface mode Answer: C
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Family Members Arbitration For Separating Couples
Household arbitration technique is a professional task that is regulated by the Family Mediation Council. The FMC is composed of reps of the participant organisations for family members arbitration and also Resolution is a starting participant. If the events reach agreement on all issues as well as submit a Marital Settlement Agreement prior to the mediation, they might request a waiver of mediation as well as reimbursement of fees via the Staff of Court. An occupation as a family members regulation professional requires considerable official education.
A permission order is a legal record usually formulated by a solicitor laying out what you have actually concurred throughout mediation that will certainly then be sent out to the court and also accepted by a judge.
The mediator will also establish the regulations he or she expects everybody to follow.
This will certainly provide you confidence that the arbitrator you choose is trained as well as experienced.
The security of Australian family members throughout these challenging times is extremely essential.
Our top priority is to the training of highly competent specialists who supply a premium quality service for the advantage of families impacted by relationship failure. NFM Structure Household Mediation Training requires candidates to demonstrate on application that they have a high degree of important evaluation and also independent thinking, and have the capability to relate theory to practice. Prospects will require to reveal that they fulfill the "necessary" criteria established out on the person spec consisted of in the application pack. Official certifications as well as prior http://familymediationchoice.co.uk/ pertinent experience are likewise taken into consideration with outstanding proficiency and also numeracy skills being a core vital. Mediation is a fantastic, cost-efficient means for households to deal with challenging problems and also to arise with a sense of achievement.
How To Locate Legal Recommendations
Participating in a household arbitration session is totally voluntary as well as both of you should agree to moderate. Mediation works, however you will not understand whether household mediation will certainly help you unless you attempt household arbitration. On 22 April 2014 a new legislation was passed that made going to aMIAM, compulsory prior to making an application to go to the family court, or issuing family members court proceedings. A MIAM is elective for anybody that can offer documentary proof that they endured domestic abuse from the various other person or ex-partner involved in the dispute.
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Children & parenting after splitting up Talking with youngsters regarding separation Describing adult separation to youngsters is challenging. This area consists of some tips and web links to various other locations to obtain suggestions as well as support. Having relationship problems Functioning points out Relationships can be rewarding, yet also facility. You can look for support from loved ones, or obtain assist from expert solutions. As component of the choice procedure, you'll need to reveal you have the ideal personal top qualities and abilities to be a family members conciliator. Approved training suppliers might expect you to have a number of years of pertinent work experience taking care of dispute and also handling social partnerships, in addition to your degree.
Tips You Need To Understand About Family Mediation
The safety of Australian households throughout these tough times is extremely essential. Info on COVID-19 influence on services and sustains available to assist households is available below. Speak with somebody Family members Relationship Guidance Line The Family Members Relationship Suggestions Line is a nationwide telephone solution that aids households impacted by partnership or separation concerns. Family violence orders Standard info regarding family as well as domestic physical violence orders as well as links to more resources of details as well as assistance.
This consists of considering concerns such as family physical violence, safety and security, equality of negotiating power, dangers to youngsters, the emotional and also emotional wellness of participants and also any type of other issues that they believe may make FDR improper. It is compulsory under Australian household law for apart parents to attempt Household Disagreement Resolution prior to relating to a household court for parenting orders. Making use of an unique family arbitration process covered under the Family members Legislation Act 1975 called Family members Dispute Resolution. When conflicts can not be dealt with by arbitration, the issue may need to go to a court for a court to choose.
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Are Pain Doctors Wrongly Taking the Blame for the Opioid Crisis?
Dr. Masoud Bamdad and his wife, Shabnam Datalchian, emigrated from Iran to California in 1987, in pursuit of a better life for themselves and their two then-young children.
Four decades later, Dr. Bamdad is serving a 25-year sentence on a federal charge of distributing and dispensing Oxycodone, an opiate pain reliever, in Federal Medical Center (FMC) Fort Worth, a Texas prison.
Dr. Bamdad, believing he was innocent, had refused to take the plea deal he was offered, or to admit guilt, which is why the judge gave him such a high sentence.
The journey he took from clinic to jail is one of hundreds of similar, but little-known, footnotes to America’s struggle with the opioid epidemic.
Dr. Masoud’ Bamdad’s clinic in San Fernando, Ca., was raided by DEA agents in 2008.
Dr. Bamdad is a certified pain management specialist and a physician licensed to practice family medicine. After completing a four-year pathology residency at Rutgers University Medical School, a two-year fellowship at the University of California-Los Angeles Medical Center, and qualifying for a certificate in pain management at USC Holy Cross, he and his wife, a dentist, opened the “Americare Medical and Dental Clinic” in San Fernando, Ca., in 1999.
They did well, following the classic path of immigrants starting from nothing in a new land. Their clinic provided pain reliever medication, including Oxcycodone, and advice to patients suffering acute or chronic pain. The government argues that the clinic was in fact a “pill mill,” dispensing massive amounts of opiates to patients without bothering to check whether they needed them.
But as far as Dr. Bamdad was concerned, he never broke the law.
He believes, in fact, that he is a “scapegoat”–along with other convicted pain doctors like himself–for the nation’s failure to address the opioid crisis.
In an interview via email from prison, he told The Crime Report:
At the time that I was practicing medicine, there was no concern and information about the opioid epidemic, and we were all in [the] dark. The government had not prosecuted all doctors who were prescribing opioids, they just selected some doctors and used them as scapegoats to teach a lesson to others.
Patient advocates and medical experts interviewed by The Crime Report suggest he has a point.
Although they didn’t comment on the specifics of the Bamdad case, they argued that federal efforts to combat the opioid epidemic by cracking down on pain medication prescriptions are an example of government overreach that has unfairly targeted some of the most vulnerable providers.
Worse, they add, the practice has caused grievous harm to many Americans who depend on pain relievers for their chronic illnesses.
”Without access to legal prescriptions, they are forced to go to street dealers for their pills,” said Dr. Nancy Nielsen, the Senior Associate Dean for Health Policy at The University of Buffalo Jacobs School of Medicine and Biomedical Sciences.
“As we reduced the number of opioids out there, chronic pain patients become medical refugees,” she added. “People are dying.”
In the most tragic cases, according to an investigation published earlier this week by FoxNews, it has driven some desperate pain sufferers to suicide.
Leo Beletsky
Leo Beletsky, an associate professor of law and health at Northeastern University, called the government crackdown on prescribers an example of picking on “the lowest hanging fruit.”
Noting that most measurements of DEA success are based on the numbers of arrests and prosecutions, he argued that federal actions have largely ended up “ensnaring a lot of vulnerable people” who, if anything, represented minor players in a crisis that was fueled in part by the activities of major pharmaceutical firms.
The number of doctors and pain specialists imprisoned for violations of the Controlled Substances Act is still relatively small.
A Crime Report investigation identified 263 registered physicians, convicted and imprisoned on charges brought by the DEA Diversion Unit—the unit that handles controlled substances—between 2003 and 2017.
In nearly all the cases, the charges related to opioid over-prescription.
The total number of doctors affected, however, is probably much larger. While only a few hundred doctors have been incarcerated under the crackdown on over-prescribers, over 3,000 doctors have been forced by the DEA to surrender their licenses between 2011 to 2015 alone, according to figures obtained by the Pittsburgh Post-Gazette under a Freedom of Information Act request.
The “Pill Mill” Argument
Like many of the other physicians hit by the crackdown, Dr. Bamdad might have avoided a jail term by simply admitting his guilt, and giving up his license.
But when agents of the Drug Enforcement Administration (DEA) raided his clinic, he was confident that the government would discover its error. The amount of Oxycodone he prescribed to his patients, he claims, was based on guidelines set by the Medical Board of California.
The government charges, however, that he was running a “pill mill,” dispensing large amounts of opioids to his patients without thoroughly examining them.
After declining the plea deal, Dr. Bamdad was convicted on ten counts of illegally prescribing Oxycodone and three counts of illegally prescribing Oxycodone to persons under 21.
His lengthy sentence, according to U.S. District Court Judge George Wu, was justified by the scope of Masoud Bamdad’s “pill mill,” the seriousness of his illicit prescribing, and his apparent lack of remorse.
According to media reports at the time, Wu cited the prosecution’s report that for three years running — including 2008, the year of his arrest —Bamdad ranked among the state’s highest prescribers of Oxycodone, a powerful narcotic popularly known as “synthetic heroin.” The volume of his prescriptions exceeded that of many hospitals and pain management clinics, Wu said.
Dr. Bamdad counters that he never prescribed more than he was permitted under his license, and he also denies prescribing to anyone under the age of 18. He also maintains that he operated a relatively small office with three medical assistants, and rebuts government charges that he was among California’s “highest prescribers of Oxycodone.”
He said in his email:
All my prescriptions were for a legitimate quantity of painkillers for a legitimate time span, as even my defective indictment reveals. 2-3 pills per day as my indictment illuminates, only for controlling pain based on the guidelines of Medical Board of California for treating pain with narcotics at the time of my practice.
The key weapon used by the government to prosecute Dr. Bamdad and other alleged “pill mills” is the Controlled Substances Act. Advocates say the Act, which was most typically used to combat activities of drug kingpins by prosecuting them for the “manufacture, importation, possession, use, and distribution of certain substances,” is being wrongly used against many legitimate medical professionals.
Dr. Linda Cheek, a pain specialist who was incarcerated herself for over-prescribing painkillers and now leads a nonprofit , Doctors of Courage, which champions “innocent doctors” caught up in the opioid crackdown, charges the DEA has based its actions against doctors on a misinterpretation of a key section of the Controlled Substances Act,
Section 802 (56) of the Act allows the individual practitioner to determine what is “legitimate medical purpose for the issuance of [a] prescriptions;” but, Dr. Cheek argues, U.S. Attorneys and DEA agents with little or no medical training have taken it upon themselves to determine what is a “legitimate” medical purpose.
The DEA disputes such arguments, maintaining that there is nothing ambiguous about a “pill mill,” even if it calls itself a pain management clinic.
“In a typical pill mill case, you’d see hundreds of patients in a small amount of time frequenting that facility,” said Melvin Patterson, a special agent who is an official spokesperson for the DEA. “Just like you would see pills in a pill mill— they go in and out. That’s how we came up with the term.”
The charges and countercharges in Dr. Bamdad’s case reflect a much larger and more troubling issue, according to critics of the government’s anti-opioid policies.
While there have been well-publicized examples of profiteering doctors who have operated clinics as a kind of assembly-line where pain medications are dispensed freely with few questions asked, experts say the government is using the blunt weapon of prosecution to hold pain-management physicians responsible for an epidemic that had little to do with their activities.
That begs the question: Are the wrong people taking the fall for the opioid epidemic?
Who’s to Blame for the Opioid Epidemic?
The opioid crisis continues to shake America.
According to figures released by the National Institutes of Health, as of March 2018, more than 115 Americans die every day from overdosing on opiates, including prescription pain relievers, heroin, and synthetic opioids such as fentanyl.
Many critics have singled out the activities of pharmaceutical firms for blame.
So-called Big Pharma is now the target of multiple lawsuits brought by state attorneys general around the country, as well as by native Americans who contend that tribal populations were especially victimized by the opiates that flooded Indian Country.
The lawsuits contend that the production and distribution of massive amounts of pain medications over the past decades were fueled, in the words of one filing, by “a massive deceptive marketing campaign [aimed at] convincing doctors and the public that their drugs are effective for treating chronic pain and have a low risk of addiction, contrary to overwhelming evidence.”
“It’s the…pharmaceutical executives who should be in jail,” said Dr. Nielsen. “They cost lives and terrible, terrible misery.”
Joe Rannazzisi
Joe Rannazzisi, former head of the Office of Diversion Control for the Drug Enforcement Administration, agrees.
“Should some of these companies have been more heavily fined or criminally prosecuted?” he told The Crime Report. “Yes.”
Rannazzisi, who leaked details of what he said were the federal government’s efforts to deflect prosecutions against pharmaceutical companies to The Washington Post and CBS 60 Minutes in a celebrated “whistleblowing” expose, has charged that the opioid crisis was allowed to spread by “Congress, lobbyists, and the drug distribution industry that shipped almost unchecked, hundreds of millions of pills to rogue pharmacies and pain clinics—providing the rocket fuel for the opioid crisis.”
Advocates say government crackdowns on prescription providers don’t address the real roots of the epidemic, including the question of how opiates like Oxycodone came to be seen as a solution for many symptoms aside from chronic pain.
“We were told that the drugs prescribed for pain were safe, and that it was extremely rare that people became addicted,” said Dr. Nielsen. “And [we now know] that is simply not true.”
But senior management at the companies has received little more than slaps on the wrist. In 2007, three executives at Purdue Pharma pleaded guilty to misdemeanor charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused.
Opiates and Bias
One other aspect of the DEA crackdown on physicians raises additional concerns.
Dr. Cheek, who spent 24 months in prison for prescribing painkillers, believes that racial bias is a factor in many of the cases that resulted in doctors’ imprisonment. She noted that many of her fellow medical incarcerees were minorities, and were therefore considered vulnerable by authorities.
“Once the government sees these people won’t have much support…they think ‘we’ll get a plea out of them, take their money, and on to the next target,’ ” she said.
While such claims are difficult to prove, The Crime Report investigation found that of the 263 doctors incarcerated from 2003 to 2017, 26 percent were persons of color. A majority of them were immigrants to the U.S. from the Middle East or Iran. The research included checking each doctor on the DEA’s list and looking at their home countries and medical schools.
According to statistics, more than one-quarter of the 247,000 doctors licensed to practice in the U.S. have foreign medical degrees.
But while the proportion of convicted foreign-born medics matches the general proportion of foreign-born doctors in the U.S., some argue that the pain management field attracts large numbers of immigrant physicians because there are fewer barriers to entry, and is often considered to have less status by U.S. doctors.
That makes them especially vulnerable, said Leo Beletsky.
“They’ve stepped into those opportunities—some of them probably because they were discriminated against in other areas of medicine,” he said. “Not unlike men of color who don’t have other job opportunities.”
Which is why Beletsky believes that economics as well as racial bias plays a part in the prosecutions.
“Minorities are probably less likely to have the right lawyers, institutional support or someone who can address the charges brought against them,” he said.
“So they bear the brunt of these criminal investigations (while) other doctors who have the resources might be able to get out.”
Shabnam Datalchian believes her husband faces the prospect of spending the rest of his life behind bars because of their naivete about the U.S. justice system.
“It’s much easier for [the government] to go after [immigrants] because they think we don’t have the proper knowledge of the legal system… Which we honestly don’t.” she said.
DEA agents contacted by The Crime Report strongly dispute charges of bias.
“[These are] people who have violated the Controlled Substances Act,” said Melvin Patterson, a special agent and an official spokesperson for the DEA. “We go where the evidence leads us. We could care less what the person looks like or where they are from.”
Patterson said undercover DEA agents make their cases when they go into a suspected clinic and receive opioids without a medical examination.
Dr. Bamdad described the same scenario, but in a different light.
DEA agents came to his office in 2008, posing as patients, and complaining of pain.
Since pain is subjective and there is no real way to prove just how much pain a patient is experiencing, doctors are left with limited options.
They usually chose to believe their patients, Dr. Bamdad said.
The Pain Dilemma
Richard A Lawhern, director of research at the Alliance for the Treatment of Intractable Pain, who leads a nationwide effort to end the targeting of prescription opioids, argues that the prosecution of individual doctors has no medical justification.
Lawhern has contended, in a series of columns for The Crime Report, that most opioid overdose deaths are not the results of opioids prescribed for chronic pain users.
Richard A. Lawhern
The U.S. is now chasing the “wrong epidemic” in its efforts to reduce the death toll from narcotic drugs, he wrote.
According to Lawhern, the demographic analysis that supposedly connects chronic pain to addiction doesn’t bear up under careful scrutiny.
“The typical new addict is an adolescent or early-20s male with a history of family trauma, mental-health issues and prolonged unemployment,” he said in an interview. “Young men from economically depressed areas are rarely treated long-term for pain severe enough to justify use of opioids.”
In contrast, a majority of chronic pain patients (by a ratio of 60/40 or higher) are women in their 40s or older with a history of accident trauma, failed back surgery, fibromyalgia, or facial neuropathy, he said.
“And women of this age whose lives are stable enough to allow them to see a doctor don’t often become addicts.”
Other research supports Lawhern’s claim.
A recent study published in Addiction, the official journal of the Society for Addiction Studies, found that reducing opioid prescriptions has had little effect on reducing overall opioid deaths,
The study, entitled A Crisis of Opioids and the Limits of Prescription Control: United States, argues that the amount of opioids prescribed is not the sole factor leading to the rise in opioid deaths, nor even necessarily the most prominent one.
“No data supports forced opioid reductions as safe or effective,” wrote the study’s authors, Stefan Kertesz of the Birmingham School of Medicine at the University of Alabama; and Adam Gordon, of the University of Utah School of Medicine and Informatics.
The amount of overdose deaths involving prescribed opioids has remained constant since 2010, despite a reduction in the amount of opioids being prescribed. This “lack of return” is grounds for developing a new approach to the crisis, according to the study.
But so far there is little evidence that such an approach is on the drawing boards in Washington.
As the public continues to clamor for action against the opioid epidemic, the government appears to continue using the playbook from the much-criticized “War on Drugs” of the 1980s.
Hardball Tactics
One hardball tactic frequently used in cases against physicians resembles the “flip” tactics used to get suspected co-conspirators to testify against their former comrades in order to receive lighter sentences or get away with no jail time at all. Similar tactics are being used this month in the prosecution of the notorious reputed Mexican narco-boss El Chapo in his trial in Brooklyn, N.Y.
In an opioid prescription case, prosecutors may warn a doctor’s personal assistants or nurses that they will be co-defendants unless they testify against him or her.
That’s what happened to Dr. Bamdad.
He came to the DEA’s attention when a patient overdosed and died from drugs he prescribed. Members of his staff, including secretaries and nurses, were pressured into giving misleading testimony about his activities to avoid prosecution themselves, he claimed.
Dr. Bamdad believes that if the prosecutors had not introduced the evidence of his patient’s death (his patient committed suicide), no rational jury would have convicted him for prescribing what was a legal quantity of Oxycodone for controlling pain.
Shabnam Datalchian, his wife, told TCR that during the trial, one woman admitted the government threatened her with prosecution unless she testified. After Dr. Bamdad’s attorney told the prosecutor, she was released and never testified.
“It’s insane [that he was given a long sentence for helping patients, for prescribing patients with chronic pain,” Shabnam said.
“The doctors don’t know what to do. If they don’t prescribe pills they get in trouble for not treating a patient’s pain problem. But if they do…they might end up like my husband.”
Advocates suggest that a key problem is DEA investigators’ lack of training which would enable them to distinguish a doctor who is overprescribing or diverting drugs from one who has just taken on a lot of patients who take opioids.
“The DEA assumes any patient who is prescribed more than 90 milligrams of morphine daily has been over-prescribed,” Lawhern said. “[But] if you ever have the chance to talk to pain management doctors in practice, you might learn the normal range of a daily dose for pain patients is between 50 and 1,000 milligrams.”
The DEA counters that the law is clear in distinguishing legitimate doctors from those who operate the so-called “pill mills.”
“You can prescribe large amounts of opioids, but the question is, are (you) doing it within the law?” said former DEA agent Jeffrey Higgins.
“There are certain requirements when you’re licensed by DEA to prescribe drugs and part of that is seeing the patient and evaluating the needs of the patient.
“If you are prescribing without examining patients, that is a violation of the license.”
The legal requirements, he noted, include being seen by a doctor, and being evaluated on their need for pain medication.
What is ‘Legitimate Medical Purpose’?
The difficulty lies in defining the phrase legitimate medical purpose, according to Dr. Cheek.
She gave the example of the trial of Dr. John Patrick Couch in Mobile, Ala., a doctor who was sentenced to 240 months in prison for running a “massive pill mill.”
When the DEA agent was asked during the trial to define “legitimate medical practice” in pain management, he said he couldn’t answer that question because “he wasn’t a doctor,” Dr Cheek said in an interview.
That captures the principal problem connected with prosecution of pain doctors, she explained, arguing the government is trying to define “legitimate medical purpose” without any expertise.
Similarly, under questioning during Dr. Bamdad’s trial, the lead DEA investigator admitted she only had one hour of training on painkillers and medications.
“That was all her and her associates’ knowledge of medicine! Isn’t it interesting?!” Dr. Bamdad wrote in his email.
In fact, for most pain management doctors, prescribing large amounts of opioids to chronic pain patients is a legitimate medical practice Dr. Nielsen said. Sometimes, the dosages are high, depending upon the amount of patients each doctor sees, she added.
Today, at 64, Dr. Bamdad remains confused and angry, hoping his case will eventually come before the Supreme Court. His lawyer has petitioned for a review on the grounds that his constitutional rights were violated by the DEA sting.
He argued in his petition that a physician who “was practicing legitimate pain management based on his licensing agency guidelines” could not be held liable for a violation of the Controlled Substances Act that involved the distribution of controlled substances.
Appeals of his case in California have so far been unsuccessful.
Megan Hadley
Dr. Bamdad’s lawyers hold out slim hope that his petition will get anywhere. Nevertheless, he believes that the country he came to as an ambitious young man will live up to the ideals that drew him here.
“You were damned if you did and damned if you didn’t,” Dr. Bamdad wrote in his email.
“I wish I knew about the Department of Justice and DEA criminalizing treating patients with pain; if so, I never would have done it.”
Megan Hadley is senior staff writer and associate editor of The Crime Report. She welcomes comments from readers.
Are Pain Doctors Wrongly Taking the Blame for the Opioid Crisis? syndicated from https://immigrationattorneyto.wordpress.com/
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FMCS Certification Consultants: Your Gateway to Global Market Access
In today's competitive market, certification plays a vital role in ensuring that products meet international quality standards. The FMCS Certification, offered by the Bureau of Indian Standards (BIS), is a must for foreign manufacturers to sell their products in the Indian market. For businesses planning to meet this requirement seamlessly, expert guidance is crucial. Fusion Compliance Services emerges as a leading name among FMCS Certification consultants, offering comprehensive support to manufacturers across the globe.
What is FMCS Certification?
FMCS stands for Foreign Manufacturers Certification Scheme. This is an exclusive type of certification, aimed at foreign manufacturers, which obtain a BIS License in India. In this scheme, BIS carries out strict product testing, factory inspections, and compliance checkup to ensure that the goods adhere to Indian standards. The manufacturer will be provided with the most prized BIS Certification once the manufacturer clears all tests.
Given the complexity of obtaining BIS Certification online, partnering with experienced FMCS Certification consultants ensures a smooth and hassle-free process.
Why is FMCS Certification Important?
Market Entry: Without FMCS, foreign manufacturers cannot sell products in India.
Consumer Trust: The BIS Registration in India assures customers of quality and safety.
Regulatory Compliance: It ensures that products meet Indian safety and quality standards.
Competitive Edge: FMCS-certified products gain a strong advantage in the market.
Our Expertise in FMCS Certification
Fusion Compliance Services is a specialist in FMCS Certification consulting. With over two decades of experience in compliance certification services, our team of highly qualified experts simplifies the FMCS process for manufacturers worldwide.
Our services include:
BIS Certificate Registration and document preparation
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Liaison with BIS authorities for smooth approvals
We have further expanded our consultancy services to services like BIS-CRS Certification, EPR Authorization in India, WPC Approval in India, and TAC Registration Services.
Procedure for FMCS Certification
Application: Filing the application for BIS Certification in India with proper details.
Testing: Ensuring compliance with Indian standards by testing.
Factory Inspection: BIS inspects the manufacturing facility.
Grant of License: Once all processes are cleared, the manufacturer gets the BIS License in India.
Through our assistance, this multi-step process becomes streamlined and helps foreign businesses focus on their core operations.
Why Fusion Compliance Services?
At Fusion Compliance Services, we pride ourselves as being among the most trusted names for FMCS and related certifications. Here's why global manufacturers prefer us:
Expert Consultants: Our team is fully qualified in BIS Certification, EPR Regulations India, and WPC Registration Services in India.
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Other certifications we provide
Besides FMCS certification, we specialize in
EPR Certificate and EPR Registration for India's environmental compliance standards
TAC Registration Services: Approval for telecom equipment
WPC Approval in India and WPC-ETA Certification for meeting wireless communication regulations
FMCS Certification: Simplify Compliance
It is more of a strategic approach to trust and compliance for manufacturers seeking to enter the Indian market. The increased demand for certified products among foreign manufacturers has made them seek reliable certification services from companies like Fusion Compliance Services.
From BIS Certification, EPR Regulations India to WPC Registration Services in India, the same team will guide you seamlessly through each process. Our objective here at Fusion Compliance Services is providing an efficient, timely, and cost-effective solution so that our client can achieve the standards required in compliance and achieve business growth.
Reach Out Today
For FMCS Certification advice, reach out to us today through this medium
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Address: Office no. S1 520, Cloud-9, Vaishali Sector 1, Near Mahagun Metro Mall, Ghaziabad, Uttar Pradesh-201012 Phone: +91-9696966665 Email: [email protected]
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