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 Folic Acid Tablets I.P., Batch No. FA-1901.
Drug/ Medicine Name: Folic Acid Tablets I.P.
Batch No. FA-1901
Manufactured by: HLL Lifecare Limited, 11A-1 & 12/C-1, Sector-E, Industrial Area, Sanwer Road, Indore- 452 015
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, Folic Acid Tablets I.P. is failed in the test for *Hydrolysis Products & *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, Folic Acid Tablets I.P. was drawn by the Drugs Inspector/ Government of India representative of CDSCO (East Zone), Kolkata, Nizam Palace, 7th Floor (Eastern Side), 234/4, A.J.C. Bose Road, Kolkata-700 020 and forwarded to Central Drugs Laboratory (CDL), 3, Kyd Street, Kolkata- 700 016 for Test and Analysis.
Why should not to be taken the drug/ medicine ?
The drug/ medicine, Folic Acid Tablets I.P. 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 Hydrolysis Products & Assay.
Use of Folic Acid:
Folic Acid is used to make healthy red blood cells. Folic acid is used to treat or prevent Folate deficiency Anaemia and also helps the unborn baby’s brain, skull and spinal cord develop properly to avoid development problems such as spina bifida.
*Hydrolysis Products test: Hydrolysis is a reaction in the analysis of a member of compounds such as derivatives of organic acid or in the analysis of polymers. Hydrolysis is a chemical modification of the analyte.
*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.