Not specific to CLL but India is one of the leading countries in the world making generic drugs and this issue, in my opinion, is a cause for concern and why I always buy branded over the counter drugs when I need to.
Incidentally, there are allegedly the same issues in China where the FDA theoretically oversea some drug production but they are obfuscated from inspecting production and QA records
It’s worth noting that Ibrutinib will be coming off patent soon and may be manufactured in India.
The article from the UK Daily Telegraph reports that:-
"The World Health Organisation (WHO) has issued an alert over an Indian-manufactured cancer drug circulating in Lebanon and Yemen which was found to contain life-threatening levels of toxic bacteria.
Pseudomonas aeruginosa was discovered in an injectable chemotherapy agent and immune system suppressant called methotrexate, which is manufactured by Celon Labs, a biopharmaceutical company based in the southern Indian city of Hyderabad. The methotrexate injections were only found to be contaminated after children administered with the drug reported adverse effects.
India is known as the “pharmacy of the world” as its factories manufacture 20 percent of the globe’s generic drugs and 50 percent of vaccines. However, the sector has long been plagued by safety concerns and regulation breaches.
Last year, Indian-made cough syrups were linked to the deaths of over 300 children in Gambia and Uzbekistan. In October and November 2022, approximately five per cent of the 2,767 drugs and medical devices tested by the Indian government’s regulator were found to be spurious, not of standard quality, adulterated or misbranded. More than 80 companies who failed quality testing stated on their website that they sold their products abroad, including two firms who export to the United Kingdom.
In February, Global Pharma Healthcare, an Indian pharmaceutical company based in the southern Indian city of Chennai, recalled its Artificial Tears Lubricant Eye Drops. The product, which was distributed in turn by two American pharmaceutical companies, was linked to an outbreak of pseudomonas infections and three deaths in the United States.
According to Prashant Reddy, a co-author of the book “The Truth Pill: The Myth of Drug Regulation in India”, some Indian companies and regulators do not adequately quality test their active pharmaceutical ingredients (APIs) or finished products before export, while corruption is also rife,“
The Indian government pats itself on the back as the pharmacy of the world – it is one of the country’s few big success stories so there is no incentive to really crackdown,” adds Mr Reddy.“It is a systemic issue. The implementation of standards and enforcement by drug regulators is sporadic across different Indian states and many drug labs do not do comprehensive testing of their products and only do a small subset.”
thank you for educating us & sharing this information. I wasn’t aware of India’s % re manufacturing meds. It’s so alarming to hear this, we take safety for granted in the UK, but these poorer countries with many challenges appear to sadly be targeted with low standard meds. Let’s hope with the media highlighting such concerns India will improve upon their standards.
Jackie, thank you for the warning but what can we do about it? I'm not sure where Venetoclax is made but I have to accept whatever UCLH send me. Similarly my wife has an infusion of the generic version of infliximab at the Royal Free every 8 weeks. Who knows. Presumably whoever is buying for the NHS is aware of the problems in India??
you have more protection with NHS drugs but counterfeit and poor quality drugs are a huge problem world wide. Poorer countries suffer more than most from this.
Some generics are made in the US. The US also does a certain amount of post-manufacturing quality testing. It's not that US "branded" drugs are all made in the US, it's that the QC testing is more rigorous.
I have firsthand experience of being affected by a generic made in India. Several years ago, after picking up a refill of generic Lexapro (antidepressant), my depression came back. A lovely young pharmacist helped me pinpoint that this generic was from a pharm company in India. The company I typically got was no longer making Lexapro. She searched for a US company and found one. To this day, I will only accept that company and have CVS refill it if they forget.
Thank you for the information as I’ve been taking a drug (for another condition) that I’ve gotten from India for years. I will definitely stop buying it from there immediately.
Sad but true. Keep in mind, much as anything else designed in the US, electronics (including medical) computers, etc., ANYTHING that can be moved offshore, will be. For medical electronics, even portions of the assembly can be moved to "contract mfr'rs". It is likely not well known, but after a drug is developed here, it is moved for. production offshore, e.g., Puerto Rico, India, China, Europe. Even the Covid Vax's. US companies short-term thinking related to profits & revenue, discourage domestic factories. & equipment & Human Resources (i.e., people/employee issues & benefits). Easier to contract out the mfg'g
Imbruvica is mgr'd in India, & even better, India has a GENERIC version.
My goodness, even in-country items. I am thinking of food borne illnesses in the US, most recently Salmonella suspected from raw flour. No more raw cookie dough! Especially if it's a tube from some company! Cook those pancakes thoroughly! and so on....
sorry I find this hard to believe and propaganda to stop people purchasing cheap medication.
This is the kind of stuff the Labour government is saying in New Zealand and banning some generic cancer treatments from other countries from been imported into New Zealand because the government is missing out on their profits. Yet there’s people dying of blood cancer in New Zealand and have to find over $10k a month to survive on the drugs that are free in most other developed countries. New Zealanders need countries like India and Sri Lanka to produce cheaper medication as there is very little funded meds in Nz.
I have friends been cut off from generic drugs from Sri Lanka and now have to die at the age of 44 and leave 2 young kids and a loving husband behind all because of the NZ government not wanting to fund the drugs she needs that are free in the rest of the developed world. Very sad 😞
Driverps1, you are so right to state that many die because of high medical costs. Business strategies have taken over the medical profession. The Hippocratic Oath is ignored by many and this is so sad for those who still follow their morals to treat the sick. I have refused filling out new patient forms that include obvious marketing purposes. I've changed doctors and hospitals, too. I keep strong and hopeful through my faith. 🙂Sandra
I myself have just started Ibrutinib last week and I’m in Nz and lucky enough I can pay my own way.
I know of so many in this country that have to sell their houses etc to pay for their meds and it’s a hot topic in this country.
Pharmac just refuse to find drugs here that are first line treatment in other countries.
I love living in Nz but it’s not a great place for health care and the Labour government has just made it worse by suggesting to ban go fund me pages.
I don’t mean to be sounding anti government but when these things hit home you realise how corrupted this government is and it’s soo frustrating as there’s nothing we can do.
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