CDSCO issues draft notification for Schedule H2 drugs

17 June, 2022

 

Central Drugs Standard Control Organization (CDSCO), the central drug regulatory agency of Government of India has issued a new draft gazette notification to notify Schedule H2 drugs and amendment in Rule 96 of Drugs and Cosmetics Act which deals with Labelling of drugs in India. This new schedule includes the list of top 300 brands of drugs being marketed in India. The amendment in Rule 96 mandates the manufacturers of Schedule H2 drugs to print or affix Bar code or QR code on the label. This draft notification is scheduled to come into force from First day of May, 2023

 

The rule states as under:

“The manufacturers of drug formulation products as specified in the Schedule H2 of the said rule, shall print or affix Bar Code 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. The stored data or information shall include the following particulars, namely:—

• Unique product identification code,
• 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”

India has taken many steps to curb the menace of Spurious drugs. This draft notification is also seen as another step well taken in India’s fight against spurious drugs.

This notification is a draft notification and CDSCO has sought objections and suggestions from any person within the period of 30 days from the day of publication of this draft GSR No. 448 (E) dated 14.06.2022.

Click here for GSR No. 448 (E) dated 14.06.2022 for complete notification and list of H2 drugs.