Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications. ... The WHO defines 'counterfeit' drugs as 'medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source'Substandard medicines are medicines that do not meet appropriate quality standards and/or specifications and may, therefore. requirements, such as the specified approved amount of active pharmaceutical ingredients (API); may contain ingredients not. Substandard medicines are medicines that do not meet appropriate quality standards and/or specifications and may, therefore, be ineffective and potentially harmful to patients. Substandard medicines may not meet the registered formulation requirements, such as the specified approved amount of active pharmaceutical ingredients (API); may contain ingredients not generally recognized as safe or may contain impurities in harmful amounts
Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health.FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation's drug supply from the threat of counterfeits.