Market Place
With Novartis shutting two plants in Germany and one in India by 2016-end, the global reliance on China for bulk drugs has increased even further, raising serious concerns over safety, supplies and national security. Which
plants? Last week, Novartis announced it will be shutting three plants of its generic business – Sandoz – by the end of 2016. The first plant is in India and the other two are located in Germany, in Gerlingen and Frankfurt. Frankfurt,
manufacturer of a key antibiotic intermediateThe Frankfurt plant is where Sandoz manufactures
7-ACA
(7-aminocephalosporanic acid), the core chemical structure (building block)
for producing a whole host of cephalosporin antibiotics. The reason given for closure -- prices of the cephalosporin active pharmaceutical ingredients (APIs) and intermediates have collapsed as Asian competitors have dumped excess capacity on the market. The shutdown of the Frankfurt facility
means that the global reliance on China for APIs, used to produce antibiotics
(such as cephalosporin) and especially
7-ACA, will increase only further. Chinese
APIs are already a security threat for India India produces a third of the world's
medicines, mostly in the form of generic drugs. However, according to an Oct 2014 report
by a Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), more
than 90 percent of the key raw materials (intermediates and APIs) that go into
making at least 15-odd essential drugs come from China.The drugs listed include the most commonly used painkiller such as paracetamol, aspirin; antibiotics such as amoxicillin and ampicillin, cephalexin, cefaclor, ciprofloxacin, ofloxacin, levofloxacin; first line diabetes drug metformin; and antacid ranitidine. There are no domestic producers left for many drugs such as penicillin-G, and its derivative 6-aminopenicillanic acid, or 6-APA.Since India is still receiving a large quantity of 7-ACA from Germany (confirmed by the import statistics available on the PharmaCompass database), 7-ACA and its derivatives were not mentioned in this report.As per news reports, the Indian government
is now worried about over-dependence on imports from China. "Any
deterioration in relationship with China can potentially result in severe
shortages in the supply of essential drugs to the country. Additionally, China
could easily increase prices of some of these drugs where it enjoys virtual
monopoly," said Bart Janssens, partner, BCG, in a news
report published in The Economic Times. Recognizing the national healthcare
security challenge facing India, the Department of Pharmaceuticals (DoP) has
decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients.’ As part of this initiative, the Indian government intends
to build
cluster parks to boost India’s self-reliance on Chinese imports. Quality,
environmental concerns over Chinese AntibioticsChinese supplies of 7-ACA have been plagued
with multiple issues in the past. In 2012, for instance, several Chinese drug
companies were accused of manufacturing 7-ACA using contaminated ‘gutter oil’, instead of more
expensive soybean oil. Gutter oil is reprocessed oil manufactured from waste oil and animal fat collected from restaurants’ fryers, drains, grease traps and slaughterhouses. Chinese restaurants can get through a lot of cooking oil and this waste oil fuels a highly profitable gutter oil black market as there are few other outlets, such as biofuel production, for this by-product.Similarly, antibiotic pollution in the rivers of China is a serious cause of concern for the Chinese. Our previous analysis, “Antibiotic
resistant superbugs: deadlier than cancer and closer to you than you think” provides a detailed overview regarding the challenge being faced. However, with growing focus on antibiotic pollution in China, a shutdown of factories failing pollution norms would be a severe setback for the global antibiotic supply chain. In addition to these challenges, quality concerns have been raised during international regulatory inspections of some of the leading antibiotic producers in China, like Zhuhai
United and North
China Pharmaceutical Company. South
African stock outs of essential drugs a global concernThe outcomes of these challenges are already being felt in countries such as South Africa which are facing an acute shortage of critical drugs. According to a report
published in Groundup, drug shortages in South Africa’s health facilities have become a crisis. The story mentioned the situation in a hospital (Stanger Hospital) in Ilembe District KwaZulu Natal, where 200 products were out of stock. These included various doses of morphine, some antibiotics and antiretrovirals, especially paediatric ones, used to treat HIV. “About a hundred patients per week are going without ranitidine which prevents stomach ulcers. Several Ilembe facilities are even out of stock of paracetamol tablets,” the Groundup report said. There are multiple reasons for the drug stock
outs. However, unprofitability because old, off-patent products are being sold by
manufacturers at prices very close to the cost of production has played a major
role. Firms are abandoning such products and seeking higher return
alternatives. In addition, due to quality failures suppliers are unable to provide lifesaving medications to the South African population. Our
ViewThe problems of stock outs and quality concerns in South Africa can easily expand across the world and can’t be addressed until the global pharmaceutical industry reduces its reliance on China for bulk drugs and intermediates. It remains to be seen if the threat to the global supply chain will make Novartis reconsider its decision or drive a national government to buy the Frankfurt facility.
Impressions: 7495
https://www.pharmacompass.com/radio-compass-blog/novartis-plant-shut-down-creates-urgency-to-find-alternatives-to-chinese-apis
#PharmaFlow by PHARMACOMPASS
30 Jul 2015
Share
The
global war on superbugs, bacteria that grow
resistant to drugs, infect humans and defy conventional medicines, just opened another
battlefront when antibiotic contamination was found in
rivers in China, which wasn’t a result of the factories that produce the antibiotics. The
situation in China can easily be replicated in other countries in the world and
in turn, could totally impact you. Latest situation in ChinaIn
the first ever comprehensive study done in China, at the
Guanzhou Institute of
Geochemistry,
rivers around densely populated regions were found to be contaminated with
antibiotics at alarmingly high levels. China
the largest producer and user of antibiotics in the world, measured
environmental concentrations (MECs) of ciprofloxacin, norfloxacin, ofloxacin, and norfloxacin at
levels up to 7560 ng/L compared with Italy (9 ng/L), USA (up to 120 ng/L) and
Germany (20 ng/L). Seven antibiotics were
found to have concentrations of over 1,000 nanograms per liter in the
environment, a level of extremely serious concern. Bacterial resistance
rates in hospitals (i.e. superbugs) are found to be directly correlated to the
environemental concentrations levels and usage of antibiotics. The Haihe River and
the Pearl Rivers, which flow through major Chinese citites of Beijing, Tianjing,
Shenzhen and Guangzhou, were found to be the most severely antibiotic-polluted water
basins. China’s Pearl River Delta,
has overtaken Tokyo to become the world’s largest urban area in both size and population. The
report, focused on 36 frequently
detected antibiotics in China and their environmental impact. The total usage
for the 36 selected chemicals was 92,700 tons in 2013 with approximately 54,000
tons of antibiotics excreted by human and animals, almost all of which, entered
the environement. It is estimated that half of all antibiotics
in China are consumed by animal livestock. Farmers overuse and abuse of antibiotics, by adding them directly to animals’ feed to promote growth. A key
contributor to the environmental contamination problem is that up to 75 percent of antibiotics, fed to animals get excreted into the environment without any waste treatment. What are the Chinese doing about it?While,
China has no established limits for the allowable level of antibiotics in the environment,
there is a strong sense of urgency to address the problem. As part of the
initiatives taken, the Chinese Academy of Sciences has drawn up an Antibiotic Intensity Map of all the country's 58 river basins to monitor the levels
of antibiotics at all times. In addition, the Chinese government is taking necessary measures against facilities, which are polluting the
environment to ensure compliance. Measures
taken need to be watched closely as China is the antibiotic supplier to most
countries in the world. As the Chinese crackdown occurs on factories polluting
the environment, European regulators have been suspending imports from Chinese
factories for GMP compliance concerns (Zhuhai United is the latest to get a
non-compliance report). Antibiotics resistance will overtake
cancer in number of deaths by 2050Globally
all countries, including China are aware that antibiotics resistance is a global healthcare challenge that will overtake cancer
in number of deaths by 2050 and cost the world economy almost $100 trillion. Not
only will antibiotic resistance become the leading cause of deaths by 2050, 90% of the 10 million deaths are expected to
occur in Asia and Africa. Deaths by comparison for cancer are estimated to be 8.3 million, diabetes 1.5 million, diarrhea 1.4 million and road accidents 1.2 million. Countries
like South Africa, where the government is battling a drug shortage crisis, is
an outcome of the situation in China as there is unavailability of commonly prescribed
antibiotics. The use of antibiotics, has become integral to the global medical and food systems. However, the concerns over the resistance to antibiotics has been declared a “national security priority” by the White House while the WHO calls it a serious, worldwide threat to public health. The
Chinese study, has added a new dimension to this global war, where
contamination of antibiotics in the water we drink has been highlighted. Contamination
caused by human and animal excrement more than the factories producing the
antibiotics. Since
humans and animals consume antibiotics globally and there is a carry over of
these antibiotics into the environment, it is worth questioning if the water we
drink is being controlled for antibiotic levels? After
all, the harm caused by passive smoking has created smoke-free laws, would it
be completely ridiculous to discuss antibiotics-free environment legislation?
Impressions: 2940
https://www.pharmacompass.com/radio-compass-blog/antibiotic-resistant-superbugs-deadlier-than-cancer-and-closer-to-you-than-you-think
#PharmaFlow by PHARMACOMPASS
25 Jun 2015
