Tag: drugs

Explained: Why Sierra Leone has declared a national emergency over Zombie drug ‘Kush’

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Sierra Leone President Julius Maada Bio has issued a national emergency amid growing demands of his administration to take action against an unprecedented growth in the use of a synthetic drug called Kush. The government claims that since it first surfaced in Sierra Leone, the extremely addictive concoction of substances has resulted in hundreds of fatalities and dozens of addicts with mental health issues.

In a late-night countrywide broadcast on April 4, President Bio declared a national emergency, referring to the drug as a “death trap” and stating that it presented an “existential crisis.”

“Our country is currently faced with an existential threat due to the ravaging impact of drugs and substance abuse, particularly the devastating synthetic drug kush.”

The death toll from Kush abusers has been rising, he said, giving the go-ahead for the establishment of a National Task Force on Drugs and Substance Abuse, whose main objective would be to address the Kush epidemic.

According to him, medical facilities with enough personnel and qualified specialists would be established in each region to provide treatment and assistance to those struggling with drug addiction.

What is a Kush that’s wreaking havoc in West Africa?

For many years, kush—a potent combination of addictive substances—was widely used throughout the nation. It is a concoction of formaldehyde, fentanyl, tramadol, cannabis, and, some claim, crushed human bones.

Notably, the nation has one of the worst rates of young unemployment in West Africa, at 60%.

Several people who spoke with the British daily The Guardian recounted horrific accounts of human bones being ground into kush, and although this is yet to be confirmed, local media reported gravedigging arrests for this reason.

Where the drug is found

Substance trafficking is made simple by the open land borders that countries like Guinea and Liberia share with Sierra Leone.

As per The Conversation, a single Kush joint may be purchased for around five leones (₹2087) and can be utilised by two or three individuals. In a single day, up to 40 joints can be ingested.

Notably, the nation has one of the worst rates of young unemployment in West Africa, at 60%.

The drug poses two risks: the user runs the risk of self-harm, and the substance is extremely addictive. The need to pay for the next dose, which is frequently accomplished through prostitution or criminal activities, is another issue.

How Kush impacts people

Depending on the person and the amount of substance used, the effects of the drug might vary. There are many different effects of cannabis, such as relaxation, exhilaration and altered consciousness.

A powerful opioid, fentanyl has a plethora of negative effects, including adrenaline and sleeplessness. Similar effects are seen by users of tramadol, an opioid that is less strong than fentanyl (100 mg of tramadol having the same impact as 10 mg of morphine), who get drowsy and spaced out, or detached from their surroundings.

According to a report by BBC, the main cemeteries in Freetown have requested police security due to the increase in kush usage since young men have been known to dig up graves.

It is unclear why ground-up human bone is one of the numerous ingredients required to produce kush.

How frequently is Kush used?

The scope of the issue, according to Dr. Jusu Mattia, acting medical superintendent of the Sierra Leone Psychiatric Teaching Hospital in Freetown, may be observed by taking a stroll around the city’s parks. “If you randomly select 10 people, seven of them will be on kush,” he told The Guardian.

The number of patients being treated for kush addiction at the hospital has greatly increased after it underwent major upgrades in recent years with funding from the global NGO Partners In Health.

In 2020, 47 users were detected. This number rose to 1,101 in 2022. However, the number of patients admitted to the Sierra Leone Psychiatric Hospital with Kush-related conditions increased by 4,000% between 2020 and 2023. The majority of them are males, ages 18 to 25.

What measures are the authorities implementing?

The World Health Organisation estimates that there are just five psychiatrists practising in Sierra Leone, a nation of around 8.4 million people. Government figures do not reveal the specific number of deaths.

Despite the dire predictions, hospital clinical psychologist Caroline Ofovwe argues there is hope, “The kush journey is not always geared towards a doomsday.” She told The Guardian that there are some patients whose families have encouraged them to become clean and become role models for others. Additionally, the hospital intends to launch a drug detox clinic soon.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Sanofi resolves 4,000 Zantac lawsuits across US, except Delaware

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Multinational pharmaceutical and healthcare company Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all US state courts besides Delaware, the company confirmed on Thursday.

The settlement, finalised last month, hinges on individual plaintiffs’ approval and is expected to conclude over time, according to a company spokesperson. While specific terms remain undisclosed, Bloomberg was the first to report on the deal.

Limited Financial Impact

Sanofi asserted that the settlement amount reflects the brief period during which Zantac was marketed and the company’s robust legal defences. They emphasised that the resolution of these cases would not significantly impact their finances.

Zantac, originally developed by GSK and approved in 1983, has been the subject of numerous lawsuits alleging its link to cancer. Sanofi acquired the over-the-counter treatment in 2016 through an asset swap with Boehringer Ingelheim.

Concerns about Zantac’s contents led to its withdrawal from the market in 2019, following scrutiny by online pharmacy Valisure.

FDA’s Action and Litigation Landscape

In 2020, the FDA instructed all companies to remove Zantac from the market due to concerns about its main ingredient, ranitidine, potentially transforming into a carcinogen, over a period of time or when exposed to high temperatures. Zantac has since returned to the market with a new formulation that does not include ranitidine.

Companies facing federal litigation, including Pfizer, gained a huge win in 2022 when a Florida district judge rejected the science backing the claims that Zantac can cause cancer. The ruling freed the drugmakers from approximately 50,000 cases that had been consolidated in the Florida court.

The state claims remain, with roughly 75,000 consolidated in Delaware, including approximately 20,000 against Sanofi.

Over the last 10 months, GSK has settled individual Zantac cases in California to avoid jury trials. With a longer history with Zantac, GSK faces more claims than the other companies, with Reuters reporting 79,000 outstanding cases in October of last year.

Maintaining Innocence Amid Settlements

Despite settlements, both Sanofi and GSK maintain their stance that Zantac does not cause cancer. Sanofi clarified that their decision to settle aims to mitigate litigation expenses and distractions rather than admitting liability.

“Consistent with the federal court’s ruling that plaintiffs had insufficient evidence that ranitidine can cause plaintiffs’ alleged cancers, the medical, scientific, and regulatory communities have extensively evaluated and have found the allegations of the plaintiffs that Zantac causes cancer to be without merit,” Sanofi’s spokesperson said. “Sanofi is settling these cases, not because we believe the claims have any merit, but rather to avoid the expense and ongoing distraction of the litigation. No concessions of liability have been made.”

Last year, an International Chamber of Commerce arbitration tribunal sided with Sanofi when Boehringer claimed that the Paris drugmaker agreed to indemnify it from future liabilities on cancer claims against Zantac.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Essential medicines to get expensive in April 2024? Health Ministry issues clarification

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Reports claiming an upsurge in medicine prices from April 1 are false and deceptive, said the Ministry of Health and Family Welfare. The clarification comes after it was reported that over 500 medications will see a substantial rise in prices from April 1, 2024.

The Drug Price Control Orders (DPCO) 2013 — which classify medications into scheduled and non-scheduled formulations — were cited in the health ministry’s report.

Scheduled formulations are those that are included in Schedule I of DPCO 2013, whereas non-schedule formulations are those that are not included in Schedule-I of DPCO 2013.

The ministry continued, explaining that the Department of Pharmaceuticals’ National Pharmaceutical Pricing Authority (NPPA) reviews the ceiling pricing of scheduled medications every year using the Wholesale Price Index (WPI).

Listed under Schedule I of the DPCO, 2013, these medications are classified as essential. According to statistics released by the Department for Promotion of Industry and Internal Trade (DPIIT), the yearly change in WPI with the base year 2011–12 for the calendar year 2023 over the equivalent period in 2022 was (+) 0.00551%.

As a result, the Authority permitted the WPI increase @ (+) 0.00551% for the scheduled medications during its meeting on March 20, 2024.

For instance, the WPI for a certain medicine in 2022 may have been ₹100, but in 2023 it might have been ₹100.00551. Accordingly, the same medication would cost you ₹100.01103 in 2024.

The ministry added that as of now, the price caps for 923 medications are in place.

The current ceiling pricing for 782 medications will not alter based on the previously stated WPI factor of (+) 0.00551%; they will stay in place until March 31, 2025.

There will be a meagre rise of ₹0.01 for 54 medications with limit prices between ₹90 and ₹261. The statement said that the corporations may or may not take advantage of this rise, given how small the permitted price increase is. The WPI-based medication ceiling price will essentially remain unchanged in FY 2024–2025.

The updated pricing details are accessible on the NPPA website, www.nppaindia.nic.in, and will take effect on April 1st, 2024.

However, the ministry further stated that a manufacturer can set the pricing in the case of non-scheduled formulation.

It is important to note that by DPCO, 2013, Paragraph 20, no producer of non-scheduled formulation may raise the MRP by more than 10% within 12 months.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Elon Musk opens up about drug use, says investors would want him to ‘keep taking it’

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Tesla and SpaceX CEO Elon Musk has spoken about his use of psychedelic drugs like ketamine and stated that it has helped him lead the company. Musk has come under scrutiny after reports about his alleged drug use and its potential impact on the companies owned by him. A few board members at Tesla and SpaceX have had concerns over his use of drugs, which they believe could have major consequences for his health and the business empire he looks after, reports said.

According to CNN, Musk has now addressed the use of ketamine in an interview with journalist Don Lemon.

“There are times when I have sort of a… negative chemical state in my brain, like depression I guess, or depression that’s not linked to any negative news, and ketamine is helpful for getting one out of the negative frame of mind,” Musk said.

Musk noted that he has a prescription for the drug from “an actual, real doctor”. He shared that he uses a small amount once every other week

The 52-year-old denied that he overused the medication as prescribed to him. If you use too much ketamine, you can’t really get work done, he said.

“I have a lot of work, I’m typically putting in 16-hour days … so I don’t really have a situation where I can be not mentally acute for an extended period of time,” he stated.

During the interview, Musk further claimed that he was ‘almost always’ sober late-night or sometimes early morning, posting sessions on social media site X.

He said that he does not drink and is unaware of ‘smoking pot’.

Musk has previously discussed his prescription usage of ketamine on X. Ketamine is mainly used as an anaesthetic in hospitals, but it is also being explored as a possible treatment for depression, anxiety, and other mental health issues.

The Tesla CEO believes his depression is genetic and does not feel that his ketamine use will have any impact on his companies or their government contracts.

“From a standpoint of Wall Street, what matters is execution… Are you building value for investors? Tesla is worth about as much as the rest of the car industry combined … so from an investor standpoint if there is something I’m taking, I should keep taking it,” he stated.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

India forms committee to revise medicine and medical device pricing

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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In a move to establish a new code for setting the prices and availability of essential medicines and medical devices in the country, the Department of Pharmaceuticals ordered the formation of a high-level committee on March 12.

According to a copy of the orders reviewed by CNBC-TV18, the committee is named “Committee for Reforms in Pricing Framework for Drugs and Medical Devices.”

It will consist of three core members: the Secretary of the Department of Pharmaceuticals, the Chairman of the National Pharmaceutical Pricing Authority, and the Senior Economic Adviser of the Department of Pharmaceuticals.

The committee is also open to having two Special Invitees from the industry: the Secretary General of the Indian Pharmaceutical Alliance and the Chief Executive Officer of the Indian Drugs Manufacturer’s Association, along with any other special invitee.

The terms of reference of the committee include institutional reforms within the National Pharmaceutical Pricing Authority (NPPA), how to balance the price and availability of essential medicines while providing incentives to the industry to sustain growth and exports, how to design a price moderation framework for medical devices while providing incentives to the industry to sustain growth and minimise imports, and how to design a price moderation framework for emerging and precision therapies to facilitate their timely reach to needy patients, all to be included in a draft of the new Drugs and Medical Devices (Control) order, as stated in the order.

The government has given three months to the committee to submit its report.

However, critics argue that the composition of the committee favours the industry and that the committee might not be able to devise a fair pricing mechanism.

Malini Aisola, Co-Convenor of Aidan, highlights several concerning aspects regarding the current committee setup. “It is important to note that two industry associations have been given the status of special invitees to the committee, which is problematic. All stakeholders should have an equal opportunity and access to engage with the committee. It risks delegitimising the committee because of its bias towards the pharma industry. No specific rationale has been given for the Terms of Reference (TOR).”

“There is, for example, a point about restructuring the NPPA but we are unaware of the motivation for this. Two TORs emphasise the balance of price regulation with industry incentives which gives a misleading picture that the current market-based regulations are effective or extensive, neither of which is true. The TOR is about a total redrafting of the DPCO,” Aisola said.

She also mentioned that the NPPA is still primarily dependent on a proprietary database, Pharmatrac, for setting prices. “What is lesser known is that the database is controlled and owned by top Indian pharma companies. All of these taken together indicate a rising influence of the industry in policymaking. On the eve of elections, the government appears to be undermining an already weak regulation and instead of reiterating commitment towards improving access to essential health products and privileging the industry,” she added.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Weight loss drugs — we are just getting started

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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When it comes to healthcare, one of the biggest stories of the year has been of weight loss drugs — Ozempic and Wegovy. The blockbuster drugs, most recently described by Oprah Winfrey as a ‘gift’ propelled the 100-year-old Danish pharma company Novo Nordisk’s market cap to more than Denmark’s domestic economy.

And while these drugs, also endorsed by the long-running weight loss program, Weight Watchers, might have been the biggest news stories of the year, they seem to be just getting started.

A few things we can expect in 2024 from these drugs could include wider prescriptions, as reports indicate that drugs such as Wegovy could cut the risks of cardiovascular incidents and strokes. Also, the drugs could be embraced by more doctors as a way to tackle wider medical conditions such as weight gain from psychiatric conditions and even menopause.

Next year is also likely to bring more clarity on the drugs being studied for other conditions, from addiction to kidney disease, and maybe more details on risks such as what happens when one stops taking the drugs. Is it a lifelong prescription, and maybe there are other side effects.

A few other monitorables will be competition, as Eli Lilly’s drug Zepbound, approved in 2023, which is rivaling the effects of bariatric surgery could pick up pace. Not to mention progress on the pill version of the drugs and, lastly, an increase in manufacturing to tackle the supply shortages due to burgeoning demand.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Govt cannot fix or revise price of non-scheduled drugs, says Delhi HC

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Delhi High Court said the government can only ‘monitor’ the minimum retail price (MRP) of non-scheduled formulations under drugs (price control) order. The court said the government can neither fix nor revise the price of the drug.

The court said that in case there is an increase in the MRP beyond this limit then it is manufacturer’s liability to deposit the overcharged amount along with interest from the date of transgression, and reduction of the MRP of the non-scheduled formulation to the level of 10% of MRP for the next 12 months.

On November 13, India’s drug pricing authority — the National Pharmaceutical Pricing Authority (NPPA) brought 33 fixed-dose combination drugs under its price regulation. A notification released by the regulator said drug manufacturers are allowed to charge Goods and Services Tax (GST) only if they have made the payment or it is payable to the government on the retail price mentioned.

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Drug pricing regulator NPPA fixes prices of 33 fixed dose combination drugs

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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India’s drug pricing authority — the National Pharmaceutical Pricing Authority (NPPA) on Monday (November 13) brought 33 fixed-dose combination drugs under its price regulation.

“In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price,” the authority said in a press release.

A notification released by the regulator said drug manufacturers are allowed to charge Goods and Services Tax (GST) only if they have made the payment or it is payable to the government on the retail price mentioned.

Also Read:Sakar Healthcare gets WHO-GMP Certification for two units in Gujarat

NPPA said every retailer and dealer needs to display a price list and a supplementary price list for easy accessibility to any person. The above-mentioned retail price is applicable only to the individual manufacturer and marketer who has applied for the same.

The move is set to make these drugs cheaper. Manufacturers failing to comply with the price cap have to return the overcharged amount along with the interest.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Drugs worth $650 billion trafficked globally, says CBIC

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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With the illegal drug trade touching $650 billion globally and having a devastating economic impact, CBIC Chairman Sanjay Kumar Agarwal on Monday called upon international customs authorities to share insights and advanced detection techniques in drug-related crimes.

As global trade continues to interconnect and economies flourish, there is a corresponding rise in the potential for unlawful movement of restricted items like antiques, cigarettes, gold and endangered wildlife species, among others, he added. “The undercurrent of illegal trade in narcotics remains strong. Global drug trafficking is estimated to be worth $650 billion, contributing 30 per cent of the overall illicit economy. It is having a devastating impact…,” said the chief of the Central Board of Indirect Taxes and Customs (CBIC).

Speaking at the Global Conference on Cooperation in Enforcement Matters organised by the Directorate of Revenue Intelligence, Agarwal said crimes involving illicit trade many a time have possible linkages with money laundering and terror financing, which impacts national security. “We understand export-import fraud threatens the global supply chain and is inimical to economic and national security. Thus, we collectively work to defeat the transnational syndicate for which there is a constant need for cooperation and coordination of national and international law enforcement agencies,” he said.

Agarwal said the theme of the conference ‘It takes a network to fight a network’ is built upon the importance of intelligence and information sharing to curb such illegal trade. He said it is vital to share “insights into emerging trends and advanced detection techniques, particularly in the context of drug-related crimes”, with the emergence of a closely connected digital world and layers of anonymity.

The CBIC chief said the landscape of smuggling, tax evasion, commercial fraud and trade-based money laundering has undergone a paradigm shift post the Covid pandemic, and the rise of e-commerce and use of crypto assets for cross-border transactions have added a layer of complexity requiring heightened focus on enforcement, regulation and international cooperation to address associated challenges.

The Indian Customs, he said, is actively exploring technologies, including big data analytics, Artificial Intelligence, image analytics, natural language understanding, network analytics and open-source intelligence to detect fraud. The theme of this conference was ‘It takes a network to fight a network’. Vital is the sharing of insights into emerging trends and advanced detection techniques, particularly in the context of drug-related crimes. In 2022, the value of global trade in goods stood at $25 trillion, while the value in services was $7 trillion, according to the World Trade Organization (WTO).

Also Read:Punjab Chief Minister Bhagwant Mann visits Golden Temple to launch a massive anti-drug campaign

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Jan Vishwas bill passed by the Rajya Sabha, experts raise red flag

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The Jan Vishwas bill has been passed by the Rajya Sabha after it received the Lok Sabha’s nod last week. The bill will decriminalise nearly 200 provisions in 42 central acts and remove imprisonment for several offences.

However, experts in the pharmaceutical industry have raised concerns over the changes to the punishment for sub-standard drugs. One of the primary concerns raised about the bill, which was recently passed by the Lok Sabha, is that it aims to decriminalise only minor offences.

According to industry watchers such as Dinesh Thakur and Prashant Reddy, this is not true. According to the two, the bill has converted all offenses punishable under section 27(D) a provision which most frequently invoked by drug inspectors in the country, into compoundable offences which means an accused can escape jail by paying a fine of Rs 5 lakh.

The fear now is that manufacturing NSQ or not of standard quality drugs will now not be considered a serious offence. A few examples of earlier cases of NSQ cases under section 27 (D) include an injection failing the test of sterility, to tablets failing quality testing, to lack of an active ingredient.

Cases involving NSQ drugs can have then have serious implications for patients from inadequate treatment to infections to even death. The fear is these serious cases could then be punishable only with fine.

This, according to experts, comes at a time when India has been in the dock for cases of poor quality drugs exported in the past one year from substandard cough syrups linked to Indian companies Marion Biotech, Maiden Pharma and QP Pharmachem to eye drops linked to vision damage in patients in Sri Lanka and the US.

Rajesh Kumar Singh, Secretary of the Department for Promotion of Industry and Internal Trade (DPIIT), addressed the Bill and stated that the department is committed to further engaging with the Inter-Ministerial Group (IMG) to identify provisions that need simplification or decriminalisation. This effort extends beyond the central level, as they also plan to involve the State level.

The primary objective of these actions is to foster an environment that promotes both ease of doing business and ease of living for citizens. As part of their approach, the DPIIT has issued advisories to states, urging them to review and assess their existing provisions. Additionally, advisory notices have been sent to central ministries to ensure comprehensive and coordinated efforts, Singh said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow