According to the Drug Controller General of India(DGCI),conviction rates in the cases of spurious drugs is abysmally low.During 2015 to 2018,India has been able to convict only 35 cases of the 606 prosecutions launched against the manufacture,sale and distribution of spurious or adulterated drugs.
Spurious or imitation drug products are formulations made to resemble another drug,especially a popular brand,in order to cash in on the popularity of the original product.The product may or may not contain the active ingredients.
Under the Drugs and Cosmetics (Amendment) Act 2008,any drug is deemed to be adulterated or spurious when used by any person for or in the diagnosis,treatment,mitigation or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body.
Earlier,Ministry of Health and Family Welfare had conducted a country-wide survey for the years 2014-16 to determine the extent of spurious drugs in the country.Total 47,012 drug samples were tested out of which 1,850 samples were declared as not of standard quality and 13 samples were declared spurious.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device.It functions under the Drugs and Cosmetics Act,1940.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
Drugs Controller General of India (DCGI) which comes under CDSCO is responsible for approval of licenses of specified categories of drugs such as blood and blood products,vaccines,IV fluids and sera in India.