KATHMANDU, Feb 4: Nepal Ausadhi Limited has been awarded the Good Manufacturing Practice (GMP) certificate for meeting the World Health Organization (WHO) standards for pharmaceutical manufacturing.
According to the company's General Manager, Kailash Kumar Paneru, the certificate was granted by the Department of Drug Administration, marking a significant milestone 50 years after the company’s establishment.
The WHO GMP is a part of quality assurance that ensures that products are consistently produced and controlled as per the quality standards appropriate to their intended use and as required by the marketing authorisation.
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To meet GMP guidelines, the manufactures must have their own well-equipped infrastructure including a microbiological lab inside their industry, while they must have their own technical staff like lab technicians and doctors, among others. A pharmaceutical requires an additional investment of over Rs 50-60 million to meet the criteria of the WHO-GMP. As of February 2023, a total of 34 Nepali pharmaceutical companies received the GMP certifications, according to the Department of Drug Administration.
Nepal Ausadhi Limited was founded in 2029 BS as a government enterprise under the Company Act of 2021 BS. The GMP standards were introduced only in 2064-65 BS, after which the company temporarily suspended its production. It resumed manufacturing in 2074 BS, adhering to WHO standards.
With the receipt of this certificate, the company is now eligible to supply its products internationally and participate in global bids. General Manager Paneru called the achievement a significant milestone for the company. Currently, it manufactures 14 types of medicines, including oral rehydration salts, hemoglobin fluids (Parts 1 and 2), and tablets.
In the future, the company plans to manufacture medicines for conditions such as cholesterol, diabetes, and hypertension. Provided the sufficient budget allocated by the government, the company can manufacture up to 98 types of medicines.
Additionally, the state-owned pharmaceutical company has also signed a Memorandum of Understanding with the Kathmandu Metropolitan City for bilateral cooperation in producing drugs for chronic diseases.
