Spurious drugs

Dr KK Aggarwal
Padma Shri and Dr B C Roy National Awardee
President, Heart Care Foundation of India
National Vice President Elect IMA

The spurious drugs trade is believed to be 30-40% of total market as focused by the media. However, according to the official reports from the Government of India, the spurious drugs amount to only 0.3 to 0.4% of the total market.

Spurious drugs are mainly the products which are deliberately and fraudulently mislabeled and manufactured to mislead and misrepresent the patients by concealing their identity, source of manufacture and its content to profiteer on the popularity of fast moving branded or generic medicines. It may or may not contain the active ingredients in the manner mentioned on the label.

Law: Drug shall seem to be spurious if it falls within the definition as per Chapter IV, Sec. 17B of the D&C Act:

a)If it is manufactured under a name which belongs to another drug; or

b)If it is imitation of or is a substitute for another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

c) If the label or container bears the name of an individual or company purporting to be manufacturer of the drug; which individual or company is fictitious or does not exist; or

d)If it has been substituted wholly or in part by another drug or substance; or

e) If it purports to be the product of a manufacturer of whom it is not truly a product.