NOT OF STANDARD QUALITY DRUGS IN INDIA: A CASE STUDY

Drugs manufactured by licenced manufacturers have been determined to be “not of standard quality” (NSQ) owing to deficiencies caused by minor variations in the drug. Defects that arise as a result of insufficient pre-formulation checks, in-process controls performed by the supplier, or hazardous conditions. Counterfeit or fake drug products are formulations manufactured to conceal the product's true identity. Spurious drugs are made to imitate another drug, particularly any famous brand. Spurious products are typically developed by unlicensed anti-social elements. Adulterated medicines are those medicines that are found to contain an adulterant or substituted medicines. The Central Drugs Standard Control Organization (CDSCO) has issued notification about 49 products, including eye drops, pain relievers, vitamins, and even antibiotics. Out of the 1,336 samples tested, 1,286 were deemed to be of good quality, 49 were deemed NSQ, and one was deemed spurious. This study analyses the implications of violating the laws and regulations stated in the D&C Act by taking the example of a case brought against a pharmaceutical company that involved in manufacturing of NSQ drugs. The study stresses the need to follow the rules to ensure that the pharmaceutical or cosmetic product is made available to the individuals in the country with acceptable standards of quality, protection and efficacy.