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: 2939
Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3086