More drugs to get QR codes amid fight against fake products, Pg14

Key Highlights:

• The Union Health Ministry has amended the Drugs Rules, 1945, to expand the scope of Schedule H2.
• This amendment brings additional categories of drugs under a QR code-based track-and-trace framework.
• All vaccines, antimicrobials, narcotic and psychotropic drugs (covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985), and all anti-cancer drugs are now included.
• Manufacturers of these drug formulations must affix a bar code or QR code on their primary or secondary packaging.
• The measure aims to curb the distribution of spurious medicines and strengthen regulatory oversight.

Detailed Insights:

• The QR code will store crucial product information, including unique identification, generic and brand names, manufacturer details, batch number, and manufacturing/expiry dates.
• This system facilitates authentication and verification of products throughout the entire supply chain.
• The expansion significantly broadens the coverage of traceability, which was previously applicable to only the top 300 pharmaceutical brands.
• The provisions for vaccines, narcotic/psychotropic drugs, and anti-cancer medicines will be effective from July 1, 2027.
• Provisions for antimicrobials will come into force from July 1, 2028.
• This initiative also contributes to the national fight against Antimicrobial Resistance (AMR) by helping identify counterfeit antimicrobial products.

Key Concepts Involved:

• Drugs Rules, 1945: Regulations established under the Drugs and Cosmetics Act, 1940, governing the manufacture, sale, and distribution of drugs in India.
• Schedule H2: A specific schedule within the Drugs Rules, 1945, outlining drugs that require a mandatory track-and-trace mechanism using QR codes.
• Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985: An Act of the Parliament of India that prohibits the production, possession, sale, and consumption of narcotic drugs and psychotropic substances.