COPD & Emphysema Support Group
COPD is a progressive disease characterized by airflow obstruction or limitation. Emphysema is characterized by loss of elasticity of the lung tissue, destruction of structures supporting the alveoli and of capillaries feeding the alveoli. Both have symptoms that include shortness of breath, among other respiratory troubles. If you are a COPD or Emphysema sufferer, join...
This article was sent to me via a good friend who lives in India......Seeing this affects all of us using Generic meds......incl. ADC..
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Last year Teva recalled 40,000 bottles of medicine manufactured for it by Indias Emcure Pharmaceuticals.
In July, the FDA issued an import alert that effectively banned the import of drugs from Emcures Hinjwadi plant.
So far this year, six Indian co's have had their manufacturing sites blacklisted by the FDA. As a result, there are now 39 drugmaking facilities in India owned by 27 different companies that have since lost clearance due to regulatory problems.
Indian companies make around 30 to 40% of the generic medicines taken in the US a market worth $44bn, according to IBISWorld as well as many drugs and vaccines used by global aid agencies for health programmes in poorer countries.
Now, they face a serious credibility crisis, as they battle to allay western regulators concerns about their manufacturing practices especially the reliability of data from trials of their medicines.
Last month, the European Union banned 700 Indian-made generic drugs, citing doubts about the credibility of clinical trials carried out by GVK Biosciences, a Hyderabad-based research organisation.
Then, last week, the World Health Organisation warned Svizera Laboratories one of four suppliers of tuberculosis drugs to its Stop TB Partnership that inspections in July had raised serious concerns about the integrity, reliability and accuracy of data generated and available at your manufacturing site, and on your ability to prevent contamination and cross-contamination of your products.
Trust has eroded so much among foreign regulators, I dont think they take anything thats said at face value, warns Dinesh Thakur, the whistleblower in the Ranbaxy case, who now runs a consultancy focused on the pharmaceutical supply chain.
Nor is this a problem solely for small, obscure companies in India. Overseas regulators have been scrutinising and banning products from some of Indias biggest and most reputable groups including Sun Pharmaceuticals, IPCA, and Wockhardt many of which have ongoing relationships with large multinational drug companies.
Last year, growth in Indian drug exports slowed to 3%, according to the Pharmaceutical Export Council of India, a government organisation. For much of the past decade, growth had stood at a robust 12 to 13% a year.
Influential US pharmacy benefit managers, such as ExpressScripts and MerckMedco, are also increasingly concerned about their dependence on Indian suppliers fearful that imports to the US market may be abruptly banned.
DG Shah, secretary of the Indian Pharmaceutical Alliance, an association of Indias top drug companies, acknowledges the industry is struggling to meet stringent US standards.
He says this reflects the inadequate training of lab technicians and supervisors, rather than any deliberate attempt to manipulate or falsify data by the companies management.
But Mr Thakur, the former whistleblower, says the problem is the lack of value that most Indians place on precision and a general acceptance of low standards by company workers, owners and managers. As a culture, weve accepted that if it meets 80 per cent of our requirements, thats OK, he says. This is not a systemic pharmaceutical industry problem. This is a systemic cultural problem.
Murali Neelakantan, former general counsel for Cipla, Indias fourth-largest drugmaker by sales, agrees that the Indian laboratory practices raising concerns among regulators have deep roots, but that it is an organisational culture issue for companies to train and incentivise their workers to follow global best practices, including sounding the alarm when tests point to quality problems.
Indians as a rule dont like to say no, and dont like to give bad news and therefore test results always have to come out good, he suggests. You know what the test is supposed to say and you try to show that.
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Last year Teva recalled 40,000 bottles of medicine manufactured for it by Indias Emcure Pharmaceuticals.
In July, the FDA issued an import alert that effectively banned the import of drugs from Emcures Hinjwadi plant.
So far this year, six Indian co's have had their manufacturing sites blacklisted by the FDA. As a result, there are now 39 drugmaking facilities in India owned by 27 different companies that have since lost clearance due to regulatory problems.
Indian companies make around 30 to 40% of the generic medicines taken in the US a market worth $44bn, according to IBISWorld as well as many drugs and vaccines used by global aid agencies for health programmes in poorer countries.
Now, they face a serious credibility crisis, as they battle to allay western regulators concerns about their manufacturing practices especially the reliability of data from trials of their medicines.
Last month, the European Union banned 700 Indian-made generic drugs, citing doubts about the credibility of clinical trials carried out by GVK Biosciences, a Hyderabad-based research organisation.
Then, last week, the World Health Organisation warned Svizera Laboratories one of four suppliers of tuberculosis drugs to its Stop TB Partnership that inspections in July had raised serious concerns about the integrity, reliability and accuracy of data generated and available at your manufacturing site, and on your ability to prevent contamination and cross-contamination of your products.
Trust has eroded so much among foreign regulators, I dont think they take anything thats said at face value, warns Dinesh Thakur, the whistleblower in the Ranbaxy case, who now runs a consultancy focused on the pharmaceutical supply chain.
Nor is this a problem solely for small, obscure companies in India. Overseas regulators have been scrutinising and banning products from some of Indias biggest and most reputable groups including Sun Pharmaceuticals, IPCA, and Wockhardt many of which have ongoing relationships with large multinational drug companies.
Last year, growth in Indian drug exports slowed to 3%, according to the Pharmaceutical Export Council of India, a government organisation. For much of the past decade, growth had stood at a robust 12 to 13% a year.
Influential US pharmacy benefit managers, such as ExpressScripts and MerckMedco, are also increasingly concerned about their dependence on Indian suppliers fearful that imports to the US market may be abruptly banned.
DG Shah, secretary of the Indian Pharmaceutical Alliance, an association of Indias top drug companies, acknowledges the industry is struggling to meet stringent US standards.
He says this reflects the inadequate training of lab technicians and supervisors, rather than any deliberate attempt to manipulate or falsify data by the companies management.
But Mr Thakur, the former whistleblower, says the problem is the lack of value that most Indians place on precision and a general acceptance of low standards by company workers, owners and managers. As a culture, weve accepted that if it meets 80 per cent of our requirements, thats OK, he says. This is not a systemic pharmaceutical industry problem. This is a systemic cultural problem.
Murali Neelakantan, former general counsel for Cipla, Indias fourth-largest drugmaker by sales, agrees that the Indian laboratory practices raising concerns among regulators have deep roots, but that it is an organisational culture issue for companies to train and incentivise their workers to follow global best practices, including sounding the alarm when tests point to quality problems.
Indians as a rule dont like to say no, and dont like to give bad news and therefore test results always have to come out good, he suggests. You know what the test is supposed to say and you try to show that.
The medicine that works best for my COPD is Singulair, which is quite pricey in the United States. In Mexico I can buy 20 tablets of generic Singulair (montelukast sodium) for less than $4 usd.
This article is not intended to frighten customers away from ADC but when you think about it...where do any of our meds come from ?
We may be ordering our meds from the local pharmacy or even the hospital pharmacy or given free samples at the doctor's office..but where were they manufactured. That isn't something that the average customer thinks about ( I don't anyway). If I recognize the brand name as an American Pharma Company, am I correct in assuming that it was manufactured by a company here in the USA that follows all the regulations of the FDA......What do they say............NEVER ASSUME ANTHING !!
Singular>>>Montelukast i did use but it is only an anti allergy med...and stopped cos i never saw much benefit as it is primary for Asthma. Avoiding pollutants and other Irritants is the best way to avoid alergies for COPD....
My opinion only as usual, so do what your doc suggests or whatever works for you....
Long-term montelukast therapy in moderate to severe COPD--a preliminary observation.
Rubinstein I1, Kumar B, Schriever C.
Author information
Abstract
The purpose of this retrospective study was to determine the effects of long-term treatment with montelukast on chronic obstructive pulmonary disease (COPD) control in a cohort of patients with moderate to severe COPD. The medical records of 20 consecutive male patients (18 African-Americans) aged 71.2 +/- 10.7 years diagnosed with moderate to severe COPD at the VA Chicago Health Care System, Chicago, Illinois, USA, and treated with oral montelukast, 10 mg every night, for 23.6 +/- 7.3 months were reviewed. Information on demographics and COPD control was extracted from each record. In each patient, a comparable follow-up period in the clinic before and after initiating montelukast therapy was reviewed and tabulated so each patient served as his own control. There was a significant improvement in complaints of shortness of breath, sputum production wheezing and nocturnal symptoms during the observation period (P < 0.05). There was a significant reduction in the use of oral and inhaled corticosteroids, inhaled bronchodilators and supplemental oxygen (P < 0.05). In addition, there was a significant reduction in the number of visits to the emergency department, number of hospitalizations and duration of hospitalizations for acute exacerbations of COPD (P < 0.05). No significant changes in FEV1 (% predicted), FEV1/FVC ratio (% predicted) and peak expiratory flow rate were recorded during this time. No side effects where reported during the observation period and no patient discontinued the medication. Collectively, these data suggest that long-term treatment with montelukast is safe and improves COPD control in elderly patients with moderate to severe COPD.
When it comes to "pollutants" one might find this interesting if not a tad scary ... (Smile)
http://www.scientificamerican.com/article/air-quality-in-bed-is-a-nightmare/
Re-The Montelukast, i never felt it did anything particularly exciting for me and was just another added cost.....Im not sure if it is popular in OZ or not but never known anyone to be on it.......If it works take it, has always been my policy....
So i did a search and this i basically what i found....
http://treato.com/Singulair,Zyrtec/?a=s
http://www.atsjournals.org/doi/abs/10.1165/rcmb.2012-0418OC#.VfIwthGqqko
Many COPD patients experience choking and airway obstruction -myself included. It gets pretty scary when you can't breathe due to throat inflammation and too much mucus and get a tiny piece of food stuck in your airway. Asthma doesn't magically disappear when you get diagnosed with COPD.
It's disconcerting that we're boxed into our choices due to cost in spite of warnings and reservations. Let's hope and pray that the med choices we must make are doing us more good than harm.