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NY Times article about Indian pharma drug quality
By Ariela Abesara
November 9, 2022
1,166 views
Table of Contents
On November 3rd, 2022, an article was published on the front page of the New York Times, reporting on an alarming incidence of prescription drug related deaths across several West African countries. In one single outbreak, 70 children in the tiny nation of Gambia are suspected to have died over recent months from a batch of contaminated Indian-made cough syrups that had been prescribed for children who were suffering from fevers.The problem of generic drugs that either fail to meet the intended purpose, or are actually contaminated with dangerous ingredients, has been endemic in several countries, including India and China, for many years. The Indian-made syrups exported to Gambia were found to have high amounts of diethylene glycol and ethylene glycol.In the case of cough syrups alone, there have been at least five mass-death episodes since the 1970s, caused by diethylene glycol contamination, the same issue as with the latest deaths in Gambia. As reported in the New York Times article, “India’s drug industry is rife with data fraud, inadequate testing and substandard manufacturing practices. While people around the world take Indian medicines every day without incident, the regulatory weaknesses give the country’s drug makers openings to cut corners and increase profits. That has created a hazardous reality far more widespread than the occasional tragic cases of mass poisonings”
If the New York Times article is making you worried!
In case the article in the NY Times has set alarm bells ringing for you, and you are wondering whether the same problem could occur when you buy prescription or OTC medications from IsraelPharm, we can say with complete assurance that all prescription drugs that we supply, whether branded or generic, meet the strictest standards. Note that these standards don’t require just that the ingredients in the drugs are safe, but also that the whole process of manufacture and delivery, including sourcing every component, through the manufacturing process, packaging and transport, are subject to stringent rules and frequent examination by qualified quality control experts.
How does IsraelPharm guarantee the quality of your drugs?
IsraelPharm can only dispense drugs to customers under the supervision of a registered pharmacist and from our licensed pharmacy.As a licensed pharmacy, IsraelPharm operates under the supervision of the Pharmaceutical Division of the Israeli Ministry of Health, which controls every aspect of production, importation and sale of pharmaceuticals. It is empowered to inspect our premises at any time, and to check the ingredients and documentation of everything we sell. It supervises the registration, standards and drug information of all pharmaceuticals that we are allowed to sell (pharmaceutical monitoring and pharmacovigilance.)IsraelPharm can only dispense drugs to customers under the supervision of a registered pharmacist and from our licensed pharmacy. The drugs must be listed in the Israeli National Drugs Registry, and we must conform to the requirements for proper prescriptions from a licensed physician, and only in the quantities and strengths permitted. There are regular inspections of our premises. We can only operate our israelpharm.com website while we are running our approved retail pharmacy as well.In this way we can ensure that all of the drugs we offer meet the applicable standards in terms of safety, quality and efficacy and that the medical and pharmacological products comply fully with the quality and safety requirements.
FAQ
Are Israeli drug standards recognized internationally?
There is an agreement between the European Union (EU) and Israel that recognizes Israel’s standards as being equivalent to European standards on the conformity and equivalence of pharmaceutical products. This means that pharmaceutical products that are made in Israel can be sold throughout the EU without having to be individually approved, and in the same way, EU-approved drugs can be sold by Israeli pharmacies. As a result, the quality assurance of all drugs sold by IsraelPharm conforms fully with the stringent rules and regulations of the EU.
Are EU and Israeli-approved drugs accepted in the US?
There are several agreements between the US Government agency responsible for control of drugs, the Food and Drugs Administration (FDA), and the equivalent body in the EU, the European Medicines Agency (EMA) that recognize each bodies’ standards. One such agreement is the mutual recognition agreement and good manufacturing practice (GMP) compliance that the EU and the USA has reached, which allows EU authorities and their FDA counterparts to:
rely on each other’s GMP inspections
waive batch testing of products on entry into their territories
share information on inspections and quality defects.
Generic drugs are cheaper, but are they as effective as FDA-approved branded ones?
Generic drugs you are getting from IsraelPharm are generally much cheaper than the brand-name equivalents – up to 70% less. You can rest assured that this is not because of any compromises in quality or effectiveness. While the original patent was held by the inventor of the drug, they had the sole rights to manufacture it, and could charge whatever price they like because competition is impossible.Once the patent has expired, a copy of a brand-name drug that has exactly the same intended use – and is designed to produce the same exact effects, and be administered via the same route and in the same dosage as the branded drug – can be manufactured by any company. A generic drug must have the same pharmacological effects as those of their brand-name counterparts. The FDA stipulates that before it will give permission for its sale, any generic drug must be proven in trials to be just as safe and effective as the equivalent brand-name drug.Generic medicines provide you with the choice of medical treatment that is as effective as brand-name products but less expensive. Generic substitution is in wide use all across the USA and Europe. Using a generic is a decision for you and your physician to make. You can prohibit substitution and we will comply. With our availability to supply generic brands, we hope to reduce our customers’ medicine costs without in any way compromising the quality of the products we deliver.
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