The pharmaceutical business in India has been under scrutiny due to the rising occurrences of medical issues and fatalities in Sri Lanka associated with Indian pharmaceuticals. Both Sri Lanka’s health authorities and Indian pharmaceutical producers must take urgent action in response to these upsetting incidents, which raise serious concerns about the effectiveness of the quality control procedures in place. The time has come to confront the covert risks posed by Indian Big Pharma and place a higher priority on patient safety and welfare.
With over half of its pharmaceutical imports coming from India, Sri Lanka has relied significantly on them as a key source of medical supplies. However, recent incidents have brought to light the ongoing difficulties that the Sri Lankan health sector faces. The problem has been made worse by a medicine shortage that has been aggravated by the nation’s economic collapse. The effectiveness of Sri Lanka’s national drug regulator has also come under fire due to grave worries over the quality of the pharmaceuticals that are readily available.
A patient’s terrible death at the Peradeniya Teaching Hospital in Kandy from an anesthetic made in India serves as a somber reminder of the dangers of importing medications. Similarly, the necessity for thorough inquiries and strict quality control procedures has been highlighted by the death of a pregnant woman who also received Indian anesthesia. Alarm bells have also been raised by the claims of patients who suffered visual damage after receiving Indian drugs after having their eyes operated on at the general hospital in Nuwara Eliya. The government and health authorities must pay urgent attention and act in response to these situations.
Counterfeit and substandard drugs
Indian drug consumers are on edge after 66 children, the majority of whom were under two years old, in a remote area of Gambia died after taking a cough syrup manufactured by Maiden Pharmaceutical Ltd., a Delhi-based company with a manufacturing facility in Kundli, Sonepat district, Haryana.
Alarmingly, the corporation has been deceiving customers by claiming that their medications have been approved by the World Health Organization (WHO) and have complied with its standards for “good manufacturing practices” (GMP).
While disputing these assertions, the WHO lab-tested four of the company’s products and discovered that they were of poor quality.
In a statement, WHO Director-General Tedros Adhanom Ghebreyesus announced that “WHO has issued a medical product alert for four contaminated medicines identified in Gambia that have been potentially linked to acute kidney injuries and 66 child deaths.”
“As of this writing, the aforementioned manufacturer has not given the WHO assurances regarding the dependability and safety of these products”.
According to laboratory testing of samples of each of the four items, diethylene glycol and ethylene glycol are present in unacceptable concentrations and act as contaminants, the WHO stated.
Cough syrups contain polypropylene glycol to increase solubility. In the Gambian case, diethylene glycol (DEG) and ethylene glycol were also added by the manufacturer to the syrups, which are both regarded as pollutants and dangerous substances. These were present in significant concentrations, which caused catastrophic liver and renal damage in the children.
Cold past
This is not the first time Maiden Pharma has been in trouble with the law. Kerala authorities discovered that the company’s products were “substandard” at least five times between 2021 and 2022. These included metformin pills, a medication for type 2 diabetes, which failed the dissolving test. There was too much aspirin in another medicine. Similarly, the samples of Macipro, a medication containing the antibiotic ciprofloxacin, that were discovered by Gujarat officials did not match the required criteria in 2015. After finding six of Maiden’s two medicine batches to be “substandard” in 2011, Bihar health authorities placed Maiden on a five-year blacklist. One batch of medicine purportedly turned out to be fake.
An Indian government drug inspector filed a lawsuit against the business in 2018 for quality violations under the Drugs & Cosmetics Act. Maiden was one of 39 businesses that Vietnam blacklisted in 2014 because they broke drug and quality control regulations.
Additional samples of the cough syrup from the batch made in Gambia are being tested by the Central Drug Standards Control Organization (CDSCO), and results should be available in 10 days.
The Gambian episode is only the very beginning. Deaths related to faulty medication frequently go unnoticed. Additionally, there are numerous Maiden Pharmas operating openly, in violation of all the laws, making a booming business. All these businesses must be penalized by the DCGI to create deterrence and tighten the rules. The CDSCO, on the other hand, needs to convey a clear message to Indian pharmaceutical companies in order to gain the trust of international regulators.
Written by – Neha Gandhi
Edited by – Nandini Pillai