12th DEC. 2020: To ensure the safety and efficacy of the public health, Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & family Welfare, Govt. of India issued alert notice in their public domain regarding harmfulness of a particular medicine which was failed in test/ analysis in Govt. Laboratory (NABL Accredited Laboratory).
In the same way it is to mention that the drug/ medicine which comes under the category of “Not of Standard Quality” (NSQ), Adulterated or Spurious after test/ analysis a circular issued to stop sale/ distribution in the market and further use of that type of medicine/ drug may cause of ill health or damage the body or may cause of death also.
The Drugs Controller General (India) has shared the information for awareness of the common public for restriction of use of the medicine Clopidogrel & Aspirin Tablets, Batch No. TACB-010.
Clopidogrel & Aspirin Tablets
Batch No. TACB-010
Manufactured by: Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Distt. Solan, Himachal Pradesh
The above mentioned drug/ medicine is declared “Not of Standard Quality” by the Govt. Analyst, Central Drugs Laboratory (CDL), 3, Kyd Street, Kolkata- 700 016.
The drug, Clopidogrel & Aspirin Tablets is failed in the test for Description, Limit of Salicylic Acid and *Assay of Aspirin as a result, it is to state that, use of the drug/ medicine is harmful to health.
The drug, Clopidogrel & Aspirin Tablets was drawn by the Drugs Inspector, Govt. of India representative at CDSCO (South Zone), Chennai, address: 2nd Floor, Shastri Bhawan, Annexe, 26, Haddows Road, Chennai-600 006 and forwarded to Central Drugs Laboratory, 3, Kyd Street, Kolkata- 700 016 for Test and Analysis.
Why should not to be taken the drug/ medicine ?
The drug/ medicine, Clopidogrel & Aspirin Tablets after test/ analysis, the Govt. Analyst declared the drug is failed to comply with the condition specified under Drugs & Cosmetics Act, 1940. The Govt. Analyst also remarked the drug sample does not conform to IP with respect to test for Description, Limit of Salicylic Acid and Assay of Aspirin.
Use of the Drug, Clopidogrel & Aspirin Tablets :
Aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent). Clopidogrel works by blocking platelets from sticking together and prevents them from forming harmful clots.
*Assay test: An assay is an investigation procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount or functional activity of target entity.