NEWS – The Drugs Technical Advisory Board (DTAB) has recommended to the Drugs Consultative Committee (DCC) the inclusion of all antibiotics in the definition of new drugs under the New Drugs and Clinical Trial (NDCT) Rules, 2019. This recommendation aims to combat the rising threat of antimicrobial resistance (AMR).

HIGHLIGHTS

Labelling Requirements

• Amendment Suggestion: The DTAB suggested amending the labelling requirements under the Drugs Rules, 1945, to include a blue strip or box for antimicrobial products.
• Rationale: This addition is intended to raise awareness about AMR and its implications.

Restrictions on Antimicrobial Sales

• Recommendation on Sales: The DTAB supported the DCC’s recommendation that no antimicrobials should be sold to non-pharmaceutical industries without the appropriate licenses.
• Context: This is in response to the recognition of AMR as a significant global health issue, emphasized in declarations by organizations such as the UNGA, G7, and G20.

AMR Threat Recognition

• Global Health Priority: The meeting highlighted AMR as a serious and growing threat to public health worldwide.
• Misuse of Antimicrobials: The Board noted that misuse of antibiotics and other antimicrobials contributes to the rise of resistance.

Blue Strip/Box Proposal

• Purpose: The proposal for a blue strip/box is designed to warn consumers about AMR and encourage responsible use of antimicrobials.
• Previous Deliberation: This idea was also discussed in the 64th DCC meeting earlier this year.

Changes to Drug Rules

• Proposal to Amend Drug Rules: The DTAB discussed amending various provisions of the Drugs Rules, 1945, to include exceptions for antimicrobials in the sale to non-pharmaceutical industries.
• Current Provisions: Existing rules allow for exemptions in the sale of drugs for processing by manufacturers of beverages, confectionery, and non-medicinal products.

Specific Proposals for Drug Rules Amendments

• Form 20B and Other Forms: The DCC recommended amendments to specific forms (20B, 20BB, 21B, 21BB) to include the phrase “except antimicrobials.”
• Justification: This amendment aims to address the use of antimicrobials in various non-pharmaceutical sectors, including food and beverages.

DRUGS TECHNICAL ADVISORY BOARD (DTAB)

• DTAB is the highest statutory decision-making body regarding technical drug matters in India.
• Operates under the Drugs and Cosmetics Act, 1940.
• It is part of the Central Drugs Standard Control Organization (CDSCO).
• DTAB advises the Central and State Governments on technical matters related to the administration of the Drugs and Cosmetics Act, 1940.
• The DTAB operates under this ministry.

DEFINITION OF NEW DRUG

• Criteria for New Drugs: According to Rule 122 E of the Drug and Cosmetic Rules 1945, a new drug is defined as one that:
  • Has not been previously used in the country.
  • Has not been recognized as effective and safe by the licensing authority for proposed claims.
  • Includes approved drugs with modified or new claims regarding indications, dosage, or administration routes.

Implications of New Drug Classification

• Documentation: If antibiotics are classified as new drugs, their manufacturing, marketing, and sale will be documented.
• Regulatory Clearance: Manufacturing and marketing clearance will need to be obtained from the Central government, rather than State drug administration.
• Prescription Requirement: Patients will only be able to purchase antibiotics with a valid prescription.