Banned Carcinogenic Drugs sales in India: In 2019, Asha’s youngest son fell ill. The three-year-old vomited frequently and refused to eat when he was in the daycare facility he attended. Asha, who works in the medical-diagnostic chain in Mumbai, consulted her trusted pediatrician. His research revealed that the child had gastroesophageal reflux disease – a condition in which the stomach acid goes up the food pipe and causes pain and nausea.
The pediatrician prescribes the most commonly used remedy for this condition, a syrup of acid-blocker ranitidine. The brand name is Rantak Syrup, and it is sold by JB Chemicals, one of the largest pharmaceutical manufacturers in India. After a two-week course, Asha’s son seemed to be recovering. But the reflux keeps coming back, and Asha says doctors are free to prescribe Rentock syrup whenever children have nausea. Last month, her son, now five years old, with a fever and nausea, received the same prescription again.
Asha does not know, however, that in many countries today the sale of ranitidine has been discontinued or strictly encircled. The USA, the European Union, and Australia have banned the sale of these popular drugs because the ranitidine molecule breaks down into a powerful carcinogen called N-Nitroso-dimethylamine or NDMA. In Canada, manufacturers are required to test samples from their batches several times during the shelf life of bat medicine to ensure that NDMA levels are below safe limits.
The cessation of ranitidine sales in multiple countries by 2020 was only one part of the biggest crisis plaguing the global pharmaceutical industry. In June 2018, the European Drug Regulator, the European Medicines Agency (EMA), launched batches of bat medicine used to treat high blood pressure, and the crisis began with a dangerously high level of NDMA called valsartan. Within three years, regulators in many other countries, including the European Agency and the US Food and Drug Administration (US FDA), Health Canada, and the Therapeutic Goods Administration of Australia, discovered many other compounds, not just NDMA. of శధాల. These contaminated drugs include two anti-tuberculosis drugs called ranitidine, rifampin, and rifapentine, two diabetes drugs called metformin and pioglitazone, and several sartan groups called valsartan, losartan, and irbesartan.
NDMA and many of its compounds – known as nitrosamines – are potent carcinogens in animals and have the same effect on humans, and these results are seriously disturbing to consumers. And the discovery of nitrosamines in most drugs suggests that pollution may be widespread. This completeness seeks to regulate nitrosamine levels in drugs by the EMA, US FDA, and other regulators. Measures so far include recalling and halting sales of contaminated batches, extensive testing of samples, and introduction of comprehensive quality-control measures to prevent future contamination. All of these actions take place in the full public view, with regulators constantly sharing their decisions with patients, physicians, and manufacturers.
- Ola Electric Scooters In Showrooms Soon
- Union Health minister Mandaviya is visiting Kerala today regarding the increase in cases of Covid-19
However, many Indian consumers of influencers like Asha have never learned about the nitrosamine problem. This is because, throughout the global turmoil, the Indian Drug Control Agency, the Central Drugs Standard Control Organization (CDSCO), did not communicate with consumers, except for occasional claims to the media that Indian drugs were not touched by the nitrosamine problem.
In fact, CDSCO doesn’t seem to have made it even bigger behind the scenes. In 2019, CDSCO head V.G. Somani sent two short and basic notices only to both and drug regulators, asking them to inform pharma companies to “certify their products” and “take appropriate measures to ensure patient safety.” These statements do not ask companies to recall or suspend sales of their products if nitrosamine levels are high or do not conduct risk assessments.
It is also unclear whether CDSCO has tested Indian products independently for nitrosamines, rather than simply leaving the drug to manufacturers. In fact, CDSCO’s four central drug-testing laboratories do not have the equipment needed to perform such tests. Answering questions from the Mint, Indian Joint Drugs Controller S.K. Ishwar Reddy said the labs do not have equipment called Liquid Chromatography-High Resolution Mass Spectrometry Systems (LC-HRMS) or Liquid Chromatography-Tandem Mass Spectroscopy Systems (LC-MS). -MS), both of which are crucial for measuring nitrosamines. It is possible that CDSCO will conduct such a test at private labs, but neither Somani nor Reddy have answered questions about whether this has ever happened.