Herbal products registration Malaysia

1
Herbal products registration Malaysia

• Dr.Kiran lal
• Persad Tropika SDN BHD.
• Johor Bahru,Malaysia
• drkiranlal_at_gmail.com

2
Malaysian scenario

• The herbal medicine industry in Malaysia is set
  to grow by 15 per cent per annum from RM9 billion
  last year.
• (Global Bio-Herbs Economic Forum Global)

3
Registration authorities

• Drug control Authority- DCA
• National Pharmaceutical control bureau- BPKF

4
Drug Control Authority -DCA

• Registration of pharmaceutical products and
  cosmetics
• Licensing of premises for importer, manufacturer
  and wholesaler
• Monitoring the quality of registered products in
  the market
• Adverse Drug Reaction Monitoring

5
BPKF

• Evaluation of technical data,
• Laboratory test, random sampling and test
• Research and information from international
  bodies
• Product recall scheme
• Reference standard system

6
What is a Registered drug

• A registered drug is a drug that is approved by
  the Drug Control Authority (DCA) for sale/use in
  Malaysia
• MAL 19991234 A/X//T/K
• Where A stands for scheduled poisons X for over
  the counter product, T for traditional product
• And K for cosmetic

7
MAL Number
8
MAL Number
9
Other requirements
10
What needs to be registered

• Over the counter products
• Anti-dandruff shampoo
• Anti-pigmentation preparation
• Oral healthcare products with therapeutic claims
  eg anti-plague
• Medicated plaster, Dietary supplements eg
  Spirulina, Chlorella, Royal Jelly, Bee Pollen
  Aloe Vera juice,

11
Over the counter drugs

• Tooth whiteners containing hydrogen
  peroxide/carbamyl peroxide
• Antiseptics/disinfectants for use on the human
  body
• Diagnostic agents for human use
• Dietary supplement

12
Traditional/herbal medicine

• (Indian and Chinese traditional medicine)
• Homeopathic medicines
• Ayurvedic medicines
• Herbal teas

13
Others

• Cosmetic products
• Veterinary products
• Medical devices and appliances
• Labeling of food product with the Food
  Department of the Health Ministry

14
Drugs Act 1952 (Revised 2000) (Malaysia

• Any person or corporate body who contravenes the
  provisions of the Control of Drugs and Cosmetics
  Regulations 1984 commits an offence and upon
  conviction shall be liable to a fine or
  imprisonment or both as provided by Section 12,
  Sale of Drugs Act 1952 (Revised 2000) (Malaysia)
  
• First Offence
• Individual RM 25,000 fine or 3 years Imprisonment
  or both
• Corporate Fine not exceeding RM 50,000
• Subsequent Offence
• RM 50,000 fine or 5 years Imprisonment or both
• Fine not exceeding RM 100,000

15
Registration fees
16
Online Registration Quest

• www.bpkf.gov.my
• www.moh.gov.my

17
Online registration
18
General Issues

• Illegal export
• Lack of enforcement
• Advertisement restrictions

19
Thank you

• Dr.Kiranlal
• Director operations
• Persada Tropika Sdn Bhd.
• drkiranlal_at_gmail.com