[1] The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
[2] The term "drug" as defined in the act, includes various substances, diagnostic, and medical devices.
The act defines "cosmetic" as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing.
[4] The act lacks specific penalties for violating provisions relating to clinical trials.
As a result, no penalties could be imposed on the Bill and Melinda Gates Foundation-funded Programme for Appropriate Technology in Health (PATH) for violating norms in conducting the HPV vaccination trials on tribal girls in Andhra Pradesh and Gujarat.