Labeling of drugs, new drugs, medical devices, cosmetics and food products is very critical as various laws are applicable on each type of product. While labeling various laws that are applicable are as follows:
- Drug Rules
- Medical Device Rules
- Cosmetics Rules
- Legal Metrology
- Food Packaging and Labeling Rules
Often, we have observed that while designing the labels, one has to refer to various rules so that the label shall be in state of compliance with all the applicable rules. This poses a frequent challenge as decisions need to be made regarding the matter to be printed, their fonts, spacing of letters and many other legal, warning and caution statements.
For instance, Rules 96 of Drug Rules, provide detailed requirements for the manner of labelling to be printed on drug products and Rule 97 provides various cautions and warnings to be printed on various type of medicines.
Requirements of legal metrology (Packaged Commodities) Rules, 2011 are applicable on all type of products but scheduled and non-scheduled formulations covered under the Drugs (Price Control) Order, 2013 have been exempted from these requirements. However, this is to be noted that no such exemption is applicable to medical devices declared as drugs.
Hence, it becomes very important to understand the nuances of labelling rules prevalent in the country to avoid unnecessary trouble. Any deviation to the applicable guidelines may invite legal and penal action.
We at API First support our client to design suitable labels of their product and make it sure that they comply with all the applicable regulations.
