Unapproved Cough, Cold, Allergy Products: DCGI Prompts Removal From Market

 DCGI announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the Indian market. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the DCGI for safety, effectiveness, and quality. People may be at greater risk when using these products than when using DCGI-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack DCGI approval.

BACKGROUND: Cough, cold, and allergy drug products are used to relieve symptoms associated with the common cold or upper respiratory allergies. These symptoms may include coughing, chest congestion, nasal congestion, itchy eyes, and sneezing. Some cough, cold, and allergy products may be purchased over the counter (OTC), while others require a prescription. See link below for a list of the unapproved prescription cough, cold, and allergy drug products DCGI intends to remove from the market.

RECOMMENDATION: Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the CliniLife Safety Information and Adverse Event Reporting Program.

1 comment:

  1. Thanks for sharing this extremely informative article on allergic cough and cold. I recently read about this on website called breathefree.com. I found it extremely helpful.