Indian-Made Chemotherapy Drugs Fail Quality Tests Globally

In a recent study, directed by Professor Marya Lieberman of the University of Notre Dame, various chemotherapy drugs manufactured in India by various organizations, have indeed been found to have not endured quality tests and thus, patients across more than 100 countries and afflicted with cancer are quite vulnerable. The testing in 189 samples of drugs on cancer, showed the result of about a fifth of the drugs being out of control in terms of quality standards, with Venus Remedies testing the worst. These drugs that are of the essence in treating diseases such as breast cancer, ovary cancer and leukaemia have proved to be either ineffective or terribly overdosed posing very serious side effects that could be life threatening. This has provoked issues regarding the worldwide regulation of the generic pharmaceutical sector and the safety of the health of the population.

Context

• Research published that the chemotherapy drugs produced by Indian pharmaceutical organizations such as Venus Remedies, Zuvius Lifesciences and GLS Pharma did not pass the quality test thus putting global cancer patients at harm. 

• Such results demonstrate severe flaws in the international drug security system and authorities control.

Key Points

Study Findings

• The survey was carried out by University of Notre Dame

• Almost one in every five chemotherapy medication manufactured by Indian firms failed to pass quality examinations

• Worst performer - all 8 cycles;phosphamide samples tested by Venus Remedies failed

• Zuvius Lifesciences, GLS Pharma are other companies involved.

• In more than 40 countries faulty drugs were distributed

Influence on Treatment of Cancer

• Medications contained either excessively high or insufficient levels of active component

• Not enough: Powerless treatment

• Too much: Toxic side effects, body parts damage, and even deaths

• Nepal, Ethiopia, Saudi Arabia and the U.S are some of the affected countries.

Drug Regulation Lapses in the globe

• Illuminates ineffective cross border regulatory of quality of generic drugs

• Nepal: No capacity to do cancer drug testing; did not recall a single drug

• Brings the regulatory enforcing in India into question as the biggest supplier of generic drugs to the world

International Public Health Implications

• In low income nations, a patient who has cancer is not able to spend money on other drugs when first medication fails

• Reveals weakness of dependence on inexpensive generic cancer medicines all over the world

• Raises demands of more robust international oversight and national change in quality control of drugs

Conclusion

The inefficiency of chemotherapy drugs manufactured in India raises severe concerns about drug quality and drug regulatory control in the world but exposes vulnerable patients with cancer to the risk of failure to cure this ailment. Although the role that India plays in the production of generic drugs is vital in ensuring that the rest of the world has access to medicine, control mechanisms should be intensified so as to certify the safety and efficiency of these medicines. Given the seriousness of some of the cases covered in the study, there is an extreme necessity to have a bigger regulation and transparency at a global level in the pharmaceutical industry to safeguard patients all over the world.