Additions to labelling requirements of drugs – Draft Drugs and Cosmetic (Amendment) Rules, 2019

The Ministry of Health and Family Welfare have released Draft Drugs and Cosmetic (Amendment) Rules, 2019 (“Draft Rules”) on August 09, 2019. The Draft Rules are open for public objections and suggestions.

A new sub-rule is proposed to be inserted by way of the Draft Rules, every “active pharmaceutical ingredient (bulk drug)” manufactured or imported in India shall bear a “Quick Response Code” on its label.

An “active pharmaceutical ingredient” (bulk drug) is defined as any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.

This Quick Response Code will store data or information readable with software application to facilitate tracking and tracing of every active pharmaceutical ingredient. The following information will be included in the data stored in the Quick Response Code –

(i)  Unique product identification code,

(ii)  Name of the Active Pharmaceutical Ingredient,

(iii)  Brand name (if any),

(iv)  Name and address of the manufacturer,

(v)  Batch number,

(vi)  Batch size,

(vii)  Date of manufacturing,

(viii)  Date of expiry or retesting,

(ix)  Serial shipping container code,

(x)  Manufacturing licence number or import licence number,

(xi)  Special storage conditions required (if any).

Quick View

The Draft Rules will ensure genuineness of Active Pharmaceutical Ingredients used to manufacture drugs. The investigating authority will be able to check basic information about an Active Pharmaceutical Ingredients by the help of a software application built in this regard in order to ensure the quantity and quality of Active Pharmaceutical Ingredients.


Disclaimer: This post has been prepared for informational purposes only. The information/or observations contained in this post does not constitute legal advice and should not be acted upon in any specific situation without seeking proper legal advice from a practicing attorney