National GMP Codes of Nepal 2072
The Government of Nepal DDA has officially implemented the Good Manufacturing Practice (GMP) Code for Pharmaceutical Products, 2072 B.S. under Rule 11 of the Drugs Registration Regulation, 2038 B.S. to ensure the quality, safety, and efficacy of medicines produced in Nepal.
The National GMP Codes set the minimum standard for manufacturing processes, covering premises, equipment, personnel, documentation, production, quality control, and storage—ensuring that every drug reaching the market meets regulatory and international quality standards.
Recent Amendments
- First Amendment – 2079/06/25 B.S. (Ministerial Level)
- Second Amendment – 2082/03/22 B.S. (Ministerial Level)
These updates reflect Nepal’s ongoing commitment to strengthening pharmaceutical manufacturing practices in line with global norms.
At Pharma Info Nepal, we believe GMP is not just a legal requirement but a professional responsibility—helping protect public health and enhance the reputation of Nepal’s pharmaceutical industry.
NATIONAL GMP CODES NEPAL
