Malaysia: NPRA Bans Chloroform and Chloroform Spirit as Preservatives (w.e.f. 19 November 2024)

Effective 19 November 2024, the National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 16/2024, announcing the prohibition of using chloroform and chloroform spirit as preservatives in pharmaceutical products, natural products, and health supplements.

Chloroform's use as a solvent is regulated under the ICH Q3C Guidelines for residual solvents. Many countries have reviewed and restricted its use, particularly as a preservative. Prolonged or high-dose exposure to chloroform can lead to severe health issues, including liver damage, kidney failure, and nervous system impairment.

Besides, chloroform is also listed under the Scheduled Poison List (Group C) in Malaysia’s Poisons Act 1952, necessitating strict regulation and monitoring.

Implementation Timeline and Key Actions

The directive outlines specific actions for product registration holders (PRH) based on the role of chloroform in their products:

1. Products Using Chloroform as a Preservative

   1. Suspension of Product Registration

Affected products will have their registration suspended, and a Level III Recall (Category B) must be executed.

b. Alternative Preservatives

PRH must submit a variation application to replace chloroform with a safer alternative:

• Pharmaceutical Products: MiV-PA16

• Natural Products and Health Supplements: MaV-8

2. Products Using Chloroform as a Solvent

   1. Justification and Control

PRH must submit justification for its continued use and provide evidence that chloroform levels in finished products comply with the limit of 60 ppm as per the ICH A3C Guidelines.

b. Variation Applications

Two options are provided:

• Submit an analysis certificate showing compliance (MiV-PA25 for pharmaceuticals; MiV-PA6 for other products)

• Replace Chloroform with an alternative (MiV-PA16 or MaV-8).

  
  

3. Implementation of New Product Registration Applications and Products Under Evaluation

   1. For products using Chloroform as a Preservative

PRH must withdraw their product registration applications (if applicable). Applications that are not withdrawn will be rejected by the Drug Control Authority (PBKD)

b. For products using Chloroform as a Solvent

PRH must justify the use of chloroform and demonstrate compliance with the chloroform content limits in finished products as specified in the ICH Q3C Guidelines.

Manufacturers and PRHs are urged to align their practices with this directive promptly. By adopting safer alternatives, the industry not only ensures compliance but also enhances consumer trust in its products.

Source: National Pharmaceuticals Regulatory Agency (NPRA)