Pharma terrorism of India . . !
THE BBC has reported that a global alert has been issued over four Indian produced cough syrups after the World Health Organization (WHO) warned they could be linked to the deaths of 66 children in The Gambia.
The syrups have been “potentially linked with acute kidney injuries and 66 deaths among children”, it said.
The products were manufactured by an Indian company, Maiden Pharmaceuticals, which had failed to provide guarantees about their safety, the WHO added.
The Secretary General of the UN has the moral responsibility of the above mentioned tragic deaths in Gambia, because the United Nations Health Agency (WHO) utterly failed in issuing prior warnings about the old track record of the substandard Indian Pharmaceutical products particularly being sold to the economically weak countries.
At least now the UN should be wise after the event and the Security Council should pass a resolution banning export (out of India) all Indian pharmaceutical products, till after the certification of the WHO that the Indian Pharmaceutical plants were producing medicines and vaccines by following the standards approved by the WHO and the FDA.
The UN Security Council should also order an inquiry of the whole tragedy to fix the specific responsibility and payment of reparations for all the deaths caused by the well known Indian official policy of supplying substandard medicines to the African countries in particular, and other economically weak countries in general, about which the WHO had all the prior information (as detailed below) for which the trial of responsible WHO and the Indian officials be conducted for causing manslaughter for pecuniary gains, at the War Crimes Tribunal at The Hague.
In this regard, given below are few links which prima facie proves that this Indian practice of exporting substandard medicines and vaccines by the Indian Pharma industry was duly published in the media and was in the full knowledge of all the concerned including the WHO.
1.India’s drug regulator has ignored red alerts on Covaxin, imperiling millions of liveshttps://www.statnews.com/2022/04/15/indias-drug-regulator-has-ignored-red-alerts-on-covaxin-imperiling-millions-of-lives/.
2.South Africa’s health minister has said the government may sell doses of AstraZeneca’s vaccine, after the country paused its rollout following a small clinical trial that showed the shot offered minimal protection against mild to moderate illness from the 501Y.V2 coronavirus variant dominant in the country.
3.Drugs exported from India to Africa are poorer quality than those sent elsewhere.
4.India continues to export substandard drugs; lack of regulations real problem: WHO.
Moreover, the latest Times of India report dated 7 October 2022 titled. Syrup shock: India has had own share of drug tragedies.
India/Rupali Mukherjee / TNN / Updated: Oct 7, 2022, 09:51 IST (exposing that Indian Pharmaceutical industry is in fact, a manslaughter industry) should also be an eye opener for the UN Security Council (which now does not need any other proof) to immediately impose relevant sanctions on India to save the humanity and punish the responsible for their crimes against humanity.
The above mentioned TOI report is also reproduced below for ready reference and to save the record which may be later on taken off to save their own skin:
MUMBAI: Some 66 deaths of children in Gambia after consumption of four cough syrups made by the Haryana-based Maiden Pharmaceuticals, the subsequent recall of the drugs by the West African country and a WHO alert have put the spotlight on quality monitoring and due diligence by companies, and the need for stricter policing by regulators.
India has also had its fair share of tragedies due to “poisonous”, sub-standard or spurious formulations.
Hence, quality control needs to be stringent, with criminal and financial liability on the perpetrators, industry experts told TOI.
“The Centre and state government need to come down heavily and swiftly on Maiden Pharmaceuticals.
India — the pharmacy of the world with one-third of the global share in drugs (by volume) — cannot afford such tragedies,” a top official with a company said.
Read Also‘Syrups linked to deaths in Gambia not sold here’.
Consider these recent examples: September 2022: Five patients died due to an anaesthetic injection, Propofol, at the Post Graduate Institute of Medical Education and Research, Chandigarh.
February 2020: 11 children died in Jammu and Kashmir due to Coldbest PC Cough Syrup, manufactured by Himachal Pradesh-based company Digital Vision.
October 2018: Batches of a polio vaccine manufactured by a Ghaziabad-based company were found contaminated with polio strain.
Read AlsoWHO issues medical product alert on four cough syrups made by India’s Maiden Pharmaceuticals.
“These are major issues of standards and controls.
Even though regulations exist on paper, implementation on the ground is so very chequered.
Hole-in-the-wall companies procure licences to manufacture drugs but follow little quality control,” said Ranjit Shahani, former VC & MD, Novartis India.
With 3,000 companies and over 10,500 manufacturing units across the country, the drug regulator faces a massive challenge in effective policing due to a shortage in personnel and funding.
Further, India does not have a robust system of reporting adverse events.
So safety checks in labs (by companies) and surprise as well as random checks (by regulatory officials) become imperative.
Reacting to the Gambia deaths, public health activist Dinesh S Thakur and lawyer Prashant Reddy T told TOI, “Schedule M in the Drugs & Cosmetics Rules, 1945 mandates testing of excipients.
Indian pharmaceutical companies do not always conduct such testing. The need of the hour is a transparent and effective public health response.
How many other batches used the adulterated excipient? Did the same trader sell the excipient to other manufacturers who used it to manufacture drugs without testing?
Once the government has this information, it needs to take steps to withdraw all these drugs.
Unfortunately, this is where the law is lacking — India has been trying to put in place a recall law since 1976 to no avail.
” Preliminary reports suggest the Haryanafirm may have used sub-standard and cheaper excipients.
Lab analysis of samples confirmed that they contain unacceptable amounts of diethylene or ethylene glycol (DEG) as contaminants, which is toxic when consumed and can prove fatal, according to WHO.
An official with industry body feels the focus has to be on quality and innovation, and not on cutting corners to make the cheapest drug.
In order to compete in the market, companies use the cheapest and sometimes poor quality ingredients, which could be life-threatening.
Further, Manoj Tongra, assistant drug commissioner FDA Rajasthan says the law is stringent.
“This is a wake-up call for companies to follow the law’’. Companies also need to tighten testing and voluntary recall of drugs from the market.
—The Lahore-based author writes on strategic, political, economic, current affairs & sports.