IPC releases draft guidelines to include Disinfectants & Antiseptics in IP

The goal is to ensure that the final guidelines align with the needs of both the industry and regulatory agencies in India.


Last Updated on March 17, 2024 by The Health Master


The Indian Pharmacopoeia Commission (IPC) has recently unveiled a pivotal draft proposal addressing the guidelines for disinfectants and antiseptics in the Indian Pharmacopoeia (IP).

This comprehensive document strives to establish robust standards governing the selection, application, and regulation of these vital pharmaceutical agents.

Manufacturers, regulatory authorities, healthcare professionals, and stakeholders are encouraged to contribute their insights and comments on this proposal before the April 15, 2024 deadline.

The IPC stresses that stakeholder engagement is paramount for refining the guidelines, tentatively set to be incorporated into the IP 2026 edition, effective July 2026.

1. Importance of Guidelines

The IPC underscores the significance of maintaining cleanliness and sterility in pharmaceutical manufacturing environments to prevent microbial contamination of products.

It outlines the necessity of implementing sound cleaning and sanitization programs to ensure the quality and safety of pharmacopoeial articles.

2. Draft Proposal Overview

A closer look at the draft proposal reveals its emphasis on various aspects of disinfectants, antiseptics, and sterilants.

This includes their classification based on chemical types, efficacy testing methods, and application procedures in sterile pharmaceutical manufacturing areas.

The proposal also underscores the regulatory compliance and safety considerations associated with the use of these agents.

3. Stakeholder Collaboration

The IPC advocates for stakeholder collaboration in developing effective cleaning and sanitization programs in the pharmaceutical industry.

The goal is to ensure that the final guidelines align with the needs of both the industry and regulatory agencies in India.

4. Role of Antiseptics

The IPC’s draft proposal highlights the critical role of antiseptics in hand and surgical site disinfection, especially in hospital settings.

Effective antiseptic use has proven to reduce bacterial counts on the skin, significantly lowering the risk of hospital-acquired infections.

5. Recommended Antiseptics

Common antiseptics recommended for such purposes include:

  • 4% chlorhexidine,
  • 10% povidone-iodine,
  • 3% hexachlorophene,
  • 70% isopropyl alcohol, and
  • 0.5% chlorhexidine in 95% alcohol.

6. Factors in Disinfectant Selection

Selecting disinfectants for pharmaceutical manufacturing environments involves careful consideration of factors such as:

  • Types of microorganisms to be controlled,
  • Spectrum of activity,
  • Concentration,
  • Application method, and
  • Contact time.

The IPC emphasizes the importance of adhering to standards supported by regulatory authorities.

7. Safety Considerations

The IPC further emphasizes safety considerations for operators applying disinfectants, highlighting the need to prevent contamination of pharmaceutical products.

Proper planning, including disinfectant rotation and measures to maintain residual bactericidal activity, is crucial to uphold hygiene standards and product integrity.

8. Regulatory Framework

Under the framework of the Drug and Cosmetic (D&C) Act 1940 and rules 1945, along with IS 1061:2017 standards, chemical disinfectants marketed in India are required to adhere to specific regulations.

9. Mandated Information

Manufacturers are mandated to provide detailed product information, including use dilution, types of microorganisms targeted, and necessary contact time.

10. FDA Regulation

Certain liquid chemical sterilizers intended for critical or semi-critical medical devices are closely regulated by the Food and Drug Administration (FDA).

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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