CDSCO flags 53 drugs as substandard in quality check, including Shelcal, Pan-D, and Paracetamol.
Team Finance Saathi
26/Sep/2024

What's covered under the Article:
CDSCO flagged 53 drugs, including Shelcal, Pan-D, and Glimepiride, as "Not of Standard Quality" in its latest drug alert.
The flagged drugs are used for conditions like high blood pressure, acid reflux, and stomach infections.
The Union Health Ministry also banned 156 fixed-dose combination drugs earlier this year due to health risks.
The Central Drug Standards Control Organisation (CDSCO) has raised significant concerns regarding the quality of certain medications in its latest alert, flagging 53 drugs as "Not of Standard Quality (NSQ)." This warning comes after random sampling conducted by state drug officers revealed that these medications failed to meet the established quality standards. The affected drugs are commonly prescribed for various health conditions, including high blood pressure, acid reflux, and erectile dysfunction, raising alarms about public health and safety.
List of Failed Drugs
Among the medications identified as failing the quality checks are well-known products like Shelcal, which contains Vitamin C and D3, the popular Pan-D antacid, Paracetamol tablets (500 mg), Glimepiride (used for diabetes), and Telmisartan (a hypertension medication). These drugs are manufactured by reputable pharmaceutical companies such as Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, and Pure & Cure Healthcare.
For instance, Metronidazole, a widely used drug for treating stomach infections produced by Hindustan Antibiotic Limited (HAL), was also flagged for quality issues. Additionally, Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare, along with Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd, have been identified in the CDSCO's latest alert.
Two Lists Issued by CDSCO
In its comprehensive alert, the CDSCO issued two lists: the first one detailing 48 popular drugs that failed quality tests, and the second including five additional drugs along with manufacturers' responses. Many companies have denied responsibility for the flagged drugs, asserting that they are "spurious" in nature. Despite these claims, the CDSCO has raised concerns that these substandard drugs are still available in the market, which poses a serious risk to public health.
Government Response to Quality Issues
This recent alert follows the Union Health Ministry's earlier decision to ban 156 fixed-dose combination (FDC) medicines in August. The ban was enacted due to serious health risks associated with these medications, which include commonly used antibiotics, painkillers, and multivitamins. A gazette notice issued on August 21 announced that the production, marketing, and distribution of these drugs would be prohibited. The notification explicitly stated that the banned FDCs encompass various drug categories, including antibiotics, anti-allergic medications, pain relievers, multivitamins, and combination treatments for conditions like fever and hypertension.
The CDSCO's alert and the government's ban on fixed-dose combination drugs underscore a growing emphasis on ensuring drug quality and safety in India. These measures aim to protect the public from potential health risks associated with substandard medications.
The CDSCO's findings highlight the urgent need for consumers to remain vigilant and aware of the medications they use. It is crucial for healthcare professionals to stay updated on these alerts to ensure that they prescribe only quality medications that have been thoroughly vetted for safety and efficacy.
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