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CHALLENGES PERSIST AS SCANDALS PLAGUE JAPAN'S GENERIC DRUG PUSH

CHALLENGES PERSIST AS SCANDALS PLAGUE JAPAN'S GENERIC DRUG PUSH

@Jackie San

As Japan pushes for generic drugs to reach an 80% market share by volume, the aftermath of a series of manufacturing scandals is leading to shortages of the more affordable alternatives to brand-name medicines, with producers rushing to meet demand.

Generics have the exact same active ingredients as brand-named medicines and provide the same effects — the difference is that they can only be manufactured and sold by other companies after the original patent expires.

Hiroyuki Sakamaki, an expert in pharmaceutical policies and health economics at the Kanagawa University of Health Services, said it will take at least three years to resolve the current shortages.

He said that most of the shortages seen today stem from a violation of Good Manufacturing Practice (GMP), a system that ensures drugs are produced and regulated based on quality standards.

Sakamaki said that around 70% of the shortage seen today is caused by scandals that were discovered in late 2020.

In December 2020, Kobayashi Kako, a generic drug manufacturer based in Fukui Prefecture, was found to have accidentally mixed sleep inducing components into its anti-fungal medicine — causing two deaths and leading to adverse health effects for over 240 people.

Around 70% of those who took the drug experienced adverse effects, such as impaired consciousness, the company said. It also emerged that the company had been falsifying pharmaceutical test results for 40 years.

Legal violations were found in nearly 80% of the company’s products, and it was found to have created fake documents used to clear inspections by prefectural authorities. Prefectural officials said executives at the company knew of the illegal conduct but did nothing to stop it. The prefecture ordered the company to suspend operations in February 2021.

The problems at Kobayashi Kako prompted nationwide on-site investigations of manufacturers conducted by prefectural authorities as well as voluntary inspections, revealing that several plants were in violation of GMP.

Within the past two years, generic-drug manufacturers, including major drug producer Nichi-Iko Pharmaceutical, received business suspension orders, highlighting problems at pharmaceutical companies across the country. This resulted in the suspensions of not only plant operations but also the shipment of a wide range of drugs.

Following the suspensions, the Japan Generic Medicines Association, an industry organization, conducted a voluntary inspection of its members and found that 31 of the 38 member companies had manufacturing procedures that were not approved by the government.

In the wake of these issues, Japan has been experiencing a massive drug shortage impacting pharmacies and medical institutions nationwide.

According to the latest survey results from the Federation of Pharmaceutical Manufacturers' Associations of Japan, 2,942 generic drugs were negatively impacted as of May, with 1,928 categorized as having “limited shipment” and 1,014 had shipments suspended. In total, 33% of generics are experiencing supply issues.

Specifically, medications for atopic dermatitis, hives, hypertension, angina, rheumatism, depression, bronchitis, antipyretics and colds have been difficult to acquire, an NHK report said.

During a health ministry meeting in early June, an expert panel addressed the unstable supply of generic drugs, calling for the establishment of a new forum for more detailed discussion.

At the meeting, a health ministry official highlighted the decline in the domestic pharmaceutical industry's international competitiveness, pointing to data on global trends and the situation in Japan.

Among 190 generic drugmakers in Japan, only 30 produce more than 100 different medicines, with 148 companies producing fewer than 50 medicines, the health ministry said in a report last month. The top eight companies dominated half of the industry.

Japanese generic drug companies tend to have low profitability, in terms of sales per company, compared with those in other countries. In Japan, 67% of generic drug companies have sales of less than ¥1 billion, while that figure is 33% in the U.S. and 11% in the U.K., the report said.

Japan’s price-setting system — in which drug prices are lowered annually — has been criticized for hindering efforts to achieve stable supply.

Mitsuro Sawai, chairman of Sawai Pharmaceutical, said his company faced an 8% decline in drug prices after fee revisions in fiscal 2023, impacting profits at the major manufacturer of generics.

“The situation is so critical that if it continues every year, Sawai may cease to exist in three years,” Sawai said in an interview this month with Mix Online, a pharmaceutical industry news site.

He added that the only viable solution would be to create a system that aligns with the government’s goal to bring the market share of generic drugs to 80%.

Sakamaki, the expert in pharmaceutical policies, said Japan has fallen behind global peers in terms of the distribution and supply of generic drugs.

He said producers put quality and compliance on the backburner, rushing to meet demand amid drawn-out government approval processes.

“In other countries, the procedures are much simpler,” Sakamaki said. “In European countries or in the U.S., if there are no issues with the quality of the drugs and no negative effects on patients, they can continue shipping out (medicine) without any interruptions.”

But he added that the manufacturing capabilities of companies also play a role. Japan's prowess in drug production is not particularly advanced, especially considering its high standards, Sakamaki said.

Sakamaki noted that while these strict standards work to ensure patient safety, they also pose hurdles for potential advancement.

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@Jackie San

Indonesia will formally chair Asean next year 2023

 Indonesia will formally chair Asean next year 2023

@Jackie San

 

JAKARTA (The Jakarta Post/Asia News Network): Just one month after chairing the internationally applauded Group of 20 (G-20) Summit, bringing together the leaders of the world’s largest 20 economies in Bali, President Joko “Jokowi” Widodo played a leadership role for the 10-member Asean during the summit to commemorate 45 years of its relationship with the 28-member European Union in Brussels on Wednesday (Dec 21).

Indonesia will formally chair Asean next year.

An ordinary Indonesian friend deciphered the President’s message as follows: We thank the Europeans for being very helpful to us when we were still poor, although some of them behaved with a colonial-master mentality. You taught us so many things, built so many infrastructures and helped our economy grow. But now we are developed enough. We want strictly equal relations. And as we have paid all our debts and obligations, please stop dictating on how to live!

Given the dispute with the EU over Indonesia’s two most-important commodities - nickel and palm oil - clear in his mind, the President said the European nations should let the South-East Asian nations develop their economies. Jokowi grew in confidence to say so because now Asean’s trade bloc with Japan, China, South Korea, Australia and South Korea has emerged as the world’s largest free-trade agreement.

 

 

“Partnerships must be based on equality. There must be no coercion. There can no longer be one side that always dictates to the other and assumes that ‘my standard is better than yours’,” Jokowi said.

The EU is now desperately watching the prolonged war in Ukraine after Russia’s invasion in February. It can only condemn Russian President Vladimir Putin, but is too afraid to confront Russia militarily. Unsurprisingly, during the summit, the EU tried in vain to persuade Asean leaders to issue a stronger statement condemning Putin.

The invasion does not only violate the United Nations Charter, but has also triggered a global crisis of energy and food. For the EU, the war inflicts nagging pains as it depends on gas and coal imports from Russia. But it does not mean that Asean should also support its way of dealing with Russia.

 

 

The EU is also desperately trying to back down from China’s economic intimidation. But it is so reliant on China it does not dare to attack China on environment and human-rights issues. It needs to find more allies to fight China because even the United States cannot help. Asean, however, will never form an alliance with the West to contain China, as it will only worsen the global crises.

Almost all of a sudden, the EU, especially its members such as Germany and France, is stepping up efforts to play a bigger military and economic role in the Indo-Pacific cooperation scheme because the area has become the world’s centre of growth. Therefore, it is becoming more eager to participate in the annual East Asian Summit, which is hosted by Asean.

The EU has a long-standing habit of preaching to developing and weaker nations on many aspects of life, especially on the environment, human rights, labour issues and good governance. But now Asean has gained confidence, although some of its members are still facing problems in upholding democracy and human rights.

In June, Indonesia told EU members that it would not be able to meet their increasing coal demand. The government officials teased the EU, saying coal was a dirty-energy source, and therefore they could not fulfil the high European standard.

 

Indonesian coal shipments to Germany, Netherlands, Spain, Italy, Poland and Switzerland increased tremendously over the first five months of the year compared with the same period of last year, Statistics Indonesia data show.

The EU recently passed an anti-deforestation law. The new rule requires all exports of palm oil, cattle, soy, coffee, cocoa, timber and rubber - as well as some derivative products such as beef and furniture - to the EU market to prove that the product’s process does not damage the forests.

We should welcome and support the noble intention to save the Earth. But remember, terms and conditions apply. It means the regulation will be strictly enforced as long as it does not affect the EU’s interests.

During the summit, European Commission president Ursula von der Leyen told Asean leaders, as the two regional-trade blocs share the same commitment to multilateralism and the international rule of law, they need to work together to oppose Russia’s aggression.

“The European Union pleads for closer cooperation between the EU and the Asean partners. Russia has unleashed its war of aggression against Ukraine. War has returned to the European continent. And it is clear that this is not solely a European problem, but the world is feeling the brutal shock waves of this war on food prices, on energy security,” she said.

The EU wants to look more flexible on the palm-oil issue because they are facing difficulties in securing supplies of edible oils, and the market mechanism will decide. So the objective of saving the Earth is not that rigid, because protecting the national economy comes first.

In the joint leaders’ statement, the summit concluded, “In the spirit of cooperation, we welcome the convening of the 2nd Joint Working Group [JWG] on Palm Oil between the relevant Asean Member States and the EU.

“We will explore further cooperation to reduce deforestation and enhance sustainable forest and land use, including through partnerships and other cooperation to promote climate-change mitigation and adaptation as well as sustainable agricultural supply chains between Asean and EU Member States,” the statement said.

Honestly, I do not believe forest protection is all that is in the EU’s mind. I will not argue the devastating impacts of the palm-oil industry on the environment, and therefore drastic measures should be taken to stop deforestation. But it is too naïve to believe business interests do not play a key role. When Ukraine exports of sunflower oil to the EU dropped due to the invasion, many EU members realized that palm oil was not that bad.

President Jokowi has arrived home from Brussels. Next year he will chair Asean. He knows very well that the regional grouping needs a European partner and vice versa.

It is a good time for the two blocs to speak up to each other so as to build a two-way dialogue. Not only Europe, but Asean too can play a preacher role for the good of all.

 

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@Jackie San

 

 

 

Pasar Malam & Bandaraya Kota Kinabalu Sabah Dilanda Hujan Lebat Serta An...

  

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BOMBA Limbang menyantuni masyarakat sekitarnya

 

https://youtu.be/2SV2lhvpJ_k 

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Mercun Buatan Sendiri Sempena Aidilfitri Tahun 2022

 

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Pasang Khemah Sendiri Di Rumah Memang Mudah

  

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DARURAT DI SRI LANKA

DARURAT DI SRI LANKA

 

@ Jackie San

COLOMBO : Pemangku Presiden Sri Lanka, Ranil WIckremesinghe mengisytiharkan darurat di negara itu, menurus satu notis yang dikeluarkan kerajaan pada 17 Julai 2022 (Ahad), ketika pentadbirannya berusaha untuk meredakan kekacauan sosial dan juga menangani krisis ekonomi yang mencengkam negara pulau itu.

 

" Ia adalah wajar untuk dilakukan, demi kepentingan keselamatan awam, perlindungan ketenteraman awam dan juga penyelenggaraan bekalan dan perkhidmatan yang penting untuk kehidupan masyarakat," katanya kepada pemberita.

 

Presiden Sri Lanka yang digulingkan iaitu Gotabaya Rajapaksa, yang melarikan diri ke luar negara pada awal Julai 2022, untuk melarikan diri daripada pemberontakan rakyat terhadap kerajaannya, berkata beliau mengambil semua langkah yang mungkin untuk mengelak krisis ekonomi yang melanda negara pulau itu.

 

Peletakan jawatan Gotabaya Rajapaksa diterima Parlimen Jumaat, 15 Julai 2022.

 

Beliau terbang ke Negara Maldives dan kemudian ke Negara Singapura selepas ratusan ribu penunjuk perasaan antikerajaan keluar ke jalan raya Colombo seminggu dan telah menduduki kediaman rasmi dan juga pejabatnya.

 

Parlimen Sri Lanka bermesyuarat bagi memulakan proses memilih presiden yang baharu, dan penghantaran bahan api tiba untuk memberikan sedikit kelegaan kepada negara yang dilanda krisis.

 

WIckremesinghe, sekutu Rajapaksa, adalah salah seorang pencabar utama untuk mengambil alih jawatan presiden sepenuh masa tetapi penunjuk perasaan juga mahu beliau berundur, yang membawa kepada prospek pergolakan lanjut sekiranya beliau dipilih kelak.

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@ Jackie San

ATAS KEBODOHAN SENDIRI, WANITA SANGGUP TIADA MARUAH HINA DIRI

HINA ISLAM TIADA KOMPROMI - DATUK IDRIS AHMAD

 

@Jackie San

KUALA LUMPUR: Kerajaan tidak akan berkompromi dengan mana-mana individu yang menghina Agama Islam dan menggugat keharmonian di negara ini.

 

Menteri di Jabatan Perdana Menteri (Hal Ehwal Agama) Datuk Idris Ahmad berkata, perbuatan melampau seperti itu tidak harus dijadikan agenda normalisasi di negara ini.

 

" Saya ingin memberikan penegasan, Jabatan Perdana Menteri (Hal Ehwal Agama) sekali-kali tidak akan berkompromi dengan apa-apa kejadian yang menghina kesucian Agama Islam, menghina Al-Quran dan Rasullullah SAW dan seumpamanya.

 

" Jika ia berlaku di Wilayah Persekutuan, saya minta Jabatan Agama Islam Wilayah Persekutuan mengambil langkah tegas membuka kertas siasatan untuk tujuan dibawa ke Mahkamah Syariah.

 

" Kalau ia berlaku di negeri kita ketahui, maka pihak berkuasa agama negeri akan ambil tindakan atau pihak Suruhanjaya Komunikasi dan Multimedia Malaysia akan ambil tindakan kalau tular dalam media sosial dan tidak diketahui lokasinya," katanya selepas merasmikan Kempen Pencegahan Jenayah Syariah 2022 di Masjid Wilayah Persekutuan di sini pada Isnin, 18 Julai 2022.

 

Beliau turut mengambil contoh kes wanita tular di media sosial selepas dikatakan menghina Agama Islam ketika membuat persembahan di sebuah kelab komedi di Taman Tun Dr Ismail, dekat sini, beliau berkata, perbuatan itu tidak harus dibiarkan berleluasa dan wanita tersebut memang berlaku bodoh dan tidak beragama.

" Seperti dilaporkan media, kandungan lawak komedi yang dipersembahkan juga menyentuh perkara sensitif yang menggangu-gugat keharmonian kemajmukan agama dan bangsa.

" Isu pentas komedi ini juga kita lihat Umat Islam khususnya berdiri teguh di belakang agensi kerajaan dan kita dapat melihat kehendak masyarakat yang mahu tindakan tegas diambil kepada pihak berkaitan yang menganjurkannya.

" Kita lihat di sini bahawa mereka yang menganjur dan memperlekehkan Agama Islam sebenarnya adalah kesan buruk ke atas agama mereka sendiri. Di mana mereka amat lemah dan tidak sembahyang atau menyembah Tuhannya maka, dengan tiadanya iman yang kuat maka sewenangnya berlaku bodoh sedemikian. Amat lawak golongan rendah mentaliti seperti wanita dan juga penganjur yang bodoh memerlukan orang ketawa melihat agama mereka sebenarnya.

" Kita tidak boleh sekali-kali membiarkan perkara ini dijadikan agenda normalisasi oleh sesetengah pihak seperti mereka yang memerlukan simpati dan akhirnya meraih duit ringgit memohon pertolongan bila disaman. Golongan sebegini amat miskin terhadap agama mereka maka, Islam menjadi punca," Jelasnya.

Sebelum ini, Siti Nuramira Abdullah, 26 tahun, yang mengaku Muslim dan menghafal 15 juzuk Al-Quran didakwa membuka tudung dan menanggalkan baju kurung ketika membuat persembahan komedi di kelab berkenaan, bulan lalu.

Dia didakwa di Mahkamah Seksyen Kuala Lumpur dan mengakut tidak bersalah atas pertuduhan menghina Agama Islam ketika membuat persembahan di kelab komedi itu.

Teman lelakinya V Alexander Navin, 38 tahun, juga didakwa di Mahkamah Seksyen atas pertuduhan membuat dan memulakan hantaran video jelik di Instagram dan Youtube milik mereka.

Selain itu, seorang lelaki ditahan polis pada 17 Julai 2022 (Ahad) atas dakwaan menghina Agama Islam menerusi satu rakaman video di media sosial dan dia telah direman empat hari sehingga Khamis, 21 Julai 2022.

 

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@ Jackie San

 

 

APPROVED PFIZER'S PAXLOVID PILL TO COMBAT COVID-19, INDONESIA

APPROVED PFIZER'S PAXLOVID PILL TO COMBAT COVID-19, INDONESIA

 

@Jackie San

JAKARTA, INDONESIA :Indonesia's Food and Drug Monitoring Agency (BPOM) has granted an emergency use authorisation of Pfizer's antiviral drug, Paxlovid, to treat eligible COVID-19 patients.

The approved film-coated Paxlovid contains 150 mg of nirmatrelvir co-packaged with 100mg ritonavir, according to its head, Penny Kusumastuti Lukito.

The recommended dose is 300 mg nirmatrevir, equivalent to two 150 mg tablets, with a tablet of 100 mg ritonavir, taken twide a day for five days, she said in a statement.

Previously, BPOM granted permits for two antiviral drugs, namely Favipiravir and Remdesivir in 2020, monoclonal antibody Regdanvimab (2021), and Molnupiravir (2022).

The world's fourth most populous country recorded 3,540 new cases of COVID-19 on July 17,2022.

Daily cases rose to over 3,000 on July 2022 because of the Omicron Variant, where most of the new cases were in Greater Jakarta.

Currently, Indonesia's booster shot coverage of only 25 per cent of the targeted 208 million people, having received their third dose.

 

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@ Jackie San

JOBLESS MAN FOR ALLEGEDLY INSULTING ISLAM, PROPHET MUHAMMAD - KOTA BARU, KELANTAN

JOBLESS MAN FOR ALLEGEDLY INSULTING ISLAM, PROPHET MUHAMMAD - KOTA BARU, KELANTAN

 

@ Jackie San

KOTA BARU, KELANTAN : Police detained a 35-years old man who allegedly insulted Islam on social media recently.

 

Acting Kelantan Police chief Datuk Muhamad Zaki Harun told media the suspect was detained in Kampung Bagan Chekok near Pulai Chondong, Machang, Kelantan.

 

" Police on Sunday (July 17,2022) received a report on an individual who allegedly insulted of Islam and Prophet Muhammad on Social Media, Facebook/

 

" The video clip, which had gone viral, lasted for four (4) minutes and 14 seconds.

 

" Following the report, a police team went to the village and detained the suspect at 1130 am, " he said.

 

Zaki also told media the man had admitted to uploading the video at the same place where he was arrested.

 

He added that the man, who is jobless, tested positive for drugs.

 

" He is expected to be remanded on July 19, 2022," Zaki said.

 

It is learnt that was the first such case to have been reported in Kelantan.

 

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@ Jackie San 

Ikan Segar Dari Sungai Adang & Sungai Limbang Sarawak

  

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