admin[@]morulaa[dot]com

Amendment in the Drug Rules, CDSCO, MDR India

Amendment in the Drug Rules, CDSCO, MDR India

This article is about MDR India for a notice published in the Indian Gazette on June 14, 2022, by the Indian Government’s Ministry of Health and Family Welfare. The CDSCO is requesting feedback and suggestions from individuals who are likely to be impacted before a 30-day window after the date of publication expires. 

  • These rules may be called the Drugs Rules, 2022 in the Eighth Amendment.
  • These will become effective on August 1st, 2023.

In  rule 96, after sub-rule (5) and before the explanation, the following sub-rules will be inserted – 

  • (6)The manufacturers of drug formulation products as specified in Schedule H2 (The link is found below) need to print or affix Barcode or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.
  • (7) The stored data or information referred to in sub-rule (6) need to  include the following particulars, namely:—
    • The Unique product identification code
    • A Proper and generic name of the drug
    • Brand name
    • Name and address of the manufacturer
    • Batch number
    • Date of manufacturing
    • Date of expiry
    • Manufacturing license number

Subscribe to our website to receive the most recent information about medical news from around the world. A group of internal Morulaa professionals may be able to assist you with regulatory compliance in India and the SEA. Contact Morulaa advisors for further details about MDR in India and Southeast Asia.


Source – Central Drugs Standard Control Organization, India

Let’s Talk

Request your free proposal. Call us today, or fill out the form and we will get right back to you!

Let’s Talk

Request your free proposal. Call us today, or fill out the form and we will get right back to you!