So the DGFT issued a diktat that all cough syrup for export needed to be tested before shipped out because of the public fall out from the deaths of children.
And because we began testing these "for export" medicines, we found that over 50 failed tests for quality
1/n
2/n Does that not make you wonder what the quality of other medicines, not just cough syrups is that we export? 🤔
Here is an example. Sri Lanka did a retrospective review on withheld and recalled medicines between June 2018 and August 2021
6/n
Remember, we still dont mandate stability testing for medicines sold in our market. Therefore, we have no idea what percentage of our drug supply actually would pass standard stability tests.
Sri Lanka found that in their retrospective study, 15% failed assay (did not have
7/n enough API) and 36% had impurities. Shocking. 😱
Maybe the DGFT can mandate compulsory testing of all medicinal products we export so that we would at least know what the extent of the problem is.
Clearly, @CDSCO_INDIA_INF doesnt want to tell us.
Buyer Beware!
• • •
Missing some Tweet in this thread? You can try to
force a refresh
There appears to be a panic in the higher echelons of the government after the recent mandatory testing requirement for exports revealed that cough syrups from 50 manufacturers failed quality testing in govt. labs:
If this is the situation with exports, you can only imagine the kind of cough syrups being sold in the Indian market.
Syrups sold in India are not subject to the same testing requirements in govt. labs.
We are staring at a huge #publichealth crisis in the short term.
3/n The @MoHFW_INDIA appears to have woken up to this fact and has issued two notices this week calling for closer inspections of all facilities manufacturing cough syrups.
Here is another example of the why public deliberations are important when considering amendments to existing laws. Case in point is the Jan Vishwas Bill 2023.
You have read about the impact it will have on our drug quality by diluting penal provisons of the D&C 1/n
2/n Act 1940. One of the supposed objectives of the JV Bill is supposedly to make it easier to do business, by removing cumbersome provisions of existing laws.
Does the Bill achieve this objective? Well, lets see.
Operation of pharmacies (yes, the corner Chemist shop) is
3/n
governed in part by the Pharmacy Act, 1942. Section 42 of this act defines who a registered pharmacist is and what are her duties.
A violation of Section 42 is punishable with imprisonment for a term that may extend to six months or with a maximum fine of Rs 1,000.
2/2 This recent CAG report (covering the period 2016-17 to 2020-21) says over 11 lac medicines in Mumbai, approx 3 lac medicines in Kolkata were dispensed to CGHS members that were found to be substandard.
Know anyone in your family who gets healthcare from CGHS?
3/4 These drugs were NOT recalled, meaning, patients were allowed to consume these drugs because we, as a country, DO NOT HAVE an EFFECTIVE DRUG RECALL law.
Methylprednisolone eye drops, manufactured by Gujarat based Indiana Ophthalmics is suspected of causing infections of the eye in more than 35 people in Sri Lanka.
2/n This is not the first instance of eye drops causing harm to patients; recall that a few months ago, Global Pharma, another Indian manufacturer was cited for similar issues in the USA
3/n While we see typical noises being made about the drug regulator inspecting the company for compliance with manufacturing standards. Lets take a look and see if our own drug labs have found similar issues with eye drops sold in our country, shall we?
Last week the @epw_in published a book review of our book, ‘The Truth Pill’ by Anant Phadke – an activist who is mentioned by name in our book for being co-founder of All India Drug Action Network (AIDAN) and a trustee of LOCOST – a pharma manufacturing
1/n
2/n enterprise that has been convicted in India of manufacturing substandard drugs – the drugs in question were hypertension drugs and had less than 50% of the active ingredient mentioned on the label.
I don’t need to explain the dangerous consequences of such substandard drugs
3/n for patients suffering from hypertension. Phadke and his colleague Srinivasan have managed to keep this conviction a secret until we unearthed it in during our research.