Quality issues were found in several generic drugs by regulatory agencies in Tamil Nadu and Maharashtra. Alerts have been issued in the media for the general public.
Central Drugs Standard Control Organization
Go to source).
Cheap Indian Generic Drugs are Not Fake: WHO
The World Health Organization (WHO) has denied reports saying that more than one-third of cheap generic medicines available in the Indian market are fake.
The World Health Organization (WHO) has denied reports saying that more than one-third of cheap generic medicines available in the Indian market are fake.
‘It is crucial to stay updated on the drug quality alerts regularly issued by government authorities regarding their safety, efficacy, and quality. These alerts inform the public about substandard medications, contaminated products, or drugs with incorrect labeling. #debarred #substandard #genericdrugs #medindia’
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Why the Medications Have Been Debarred
A dozen of the generic medications prescribed by doctors for medical conditions such as thyroid disorders, cancer, and diabetes were tested by the quality control department and found to be “not of standard quality”. Furthermore, the purchasing department debarred three other generic medications for not following the process of tender norms.“None of the drugs reached the hospital wards,” said TNMSC MD, M Arvind “As soon as drugs reach warehouses, they go into quarantine for at least two weeks. During this time, samples from every batch are sent to any of the 12 accredited labs across India for quality checks,” he said.
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European Union Suspends the Sale of 700 Generic Drugs Made in India
There is no evidence of harm or lack of effectiveness in the medicines. They were taken off to ensure patient safety and to retain confidence in EU system.
There is no evidence of harm or lack of effectiveness in the medicines. They were taken off to ensure patient safety and to retain confidence in EU system.
Actions Being Taken by TN Agency for Drugs of Poor Quality
He emphasized medications that do not pass quality control will be debarred and prohibited from supply for almost two years. The quality tests are also conducted on samples of medications sent to district warehouses and government hospitals, to ensure the quality of medications is maintained over a period of time. He notified that samples that did not comply to quality standards this time need to be replaced by the manufacturing company at no additional cost and within a specified period (2✔ ✔Trusted SourceNot of Standard Quality Alert For the Month Of August -2024
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“Our system ensures that on most occasions, drugs that are spurious or those that don’t have the right dosage of active ingredients are caught at the entry level,” he said.
Maharashtra regulatory agency also reported earlier this week on the supply of counterfeit medications to government hospitals. These contained talcum powder and starch.
Furthermore, the Central Drugs Standard Control Organization (CDSCO) also communicated that more than 50 batches of medications were counterfeit. Some of these drugs are prescribed for sexual dysfunction, hypertension, acid reflux, antibiotics and paracetamol.
As per data from TNSMC, it has debarred 45 essential and specialty medications, including steroids, antibiotics, thyroid hormone replacement therapy, calcium supplements, and antidiabetics.
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Physician's Lack Agreement – Patients Prefer Branded or Generic Drugs?
Generics are not widely used, despite cost advantage, due to a lack of information to patients and reluctance from physicians to prescribe generics - A Need to educate masses
Generics are not widely used, despite cost advantage, due to a lack of information to patients and reluctance from physicians to prescribe generics - A Need to educate masses
How Drugs Not Complying to Quality Affect Patient Health
Drugs which do not comply to quality standards could be “substandard” or “not of standard quality”.The substandard medications are those which could be contaminated, adulterated, or contain harmful substances. The medications which do not meet the specified quality standards set by the regulatory authorities are not of standard quality.
Of these two types, the substandard drugs present a substantial risk to the health of patients.
It has been reported that about 0.5 percent of the total purchase of medications failed to meet quality standards, as per data from the last three years.
“We have managed to bring it down over a period of time. Generic drug manufacturers participating in the TN tender system now know they won't be able to pass quality tests with substandard drugs,” Arvind said.
These initiatives by regulatory agencies are a positive sign toward ensuring the quality and safety of medications for the general public.
References:
- Central Drugs Standard Control Organization - (https://cdsco.gov.in/opencms/opencms/en/Latest-Alerts/)
- Not of Standard Quality Alert For the Month Of August -2024 - (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIwMTI=)
Source-Medindia
Supreme Court Takes Action on Generic Medicine Prescription
Supreme Court serves notice on PIL advocating action against doctors avoiding generic prescriptions.
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