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 across the country 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 it 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 Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules),
Batch No. 191SGC040.
Drug/ Medicine Name: Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules)
Batch No. 191SGC040
Manufactured by: Synokem Pharmaceuticals Ltd., Plot No. 56-57, Sector 6A, I.I.E. (SIDCUL), Ranipur (BHEL), Haridwar- 249 403 (Uttarakhand)
The above mentioned drug/ medicine is declared “Not of Standard Quality” by the Govt. Analyst, Central Drugs Testing Laboratory (CDTL), Zonal FDA Bhawan, Bellasis Road, Government Medical Stores Depot (GMSD) Compound, Mumbai Central, Mumbai-400 008.
The drug, Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules) is failed in the test for *Assay, as a result, it is to state that, use of the drug/ medicine is harmful to health and it may cause death also.
The drug, Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules) was drawn by the Drugs Inspector/ Government of India representative of CDSCO (West Zone), Mumbai, 4th Floor, Zonal FDA Bhawan, GMSD Compound, Bellasis Rd, Mumbai Central, Mumbai-400 008 and forwarded to Central Drugs Testing Laboratory (CDTL), Zonal FDA Bhawan, Bellasis Road, Government Medical Stores Depot (GMSD) Compound, Mumbai Central, Mumbai-400 008 for Test and Analysis.
Why should not to be taken the drug/ medicine ?
The drug/ medicine, Rosloy ASP 10/75 (Rosuvastatin & Aspirin Capsules) 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 Assay.
Use of Rosuvastatin & Aspirin:
Rosuvastatin is used to lower cholesterol if you have been diagnosed with high cholesterol. It is also taken to prevent heart and blood vessel disease, heart attacks and strokes.
Aspirin is used daily for lowering the risk of heart attack, clot-related strokes and other blood flow problems in cardiovascular disease or who have already had a heart attack or stroke. Many medical professionals prescribe aspirin for these uses.
*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.