Drug companies told to walk WHO line

KATHMANDU: Nepali pharmaceutical companies have only 20 months left to register and maintain standards abiding by Good Manufacturing Practice (GMP) recommended by World Health Organisation (WHO) guideline. The deadline for meeting GMP is mid-April 2011.

WHO has defined GMP as assurance that the product not only meets the final specifications, but also should follow the same procedures under the same conditions each and every time it is made. Member states rely on WHO for expertise and guidance in regulation, safety and quality assurance of medicine through development and promotion of international norms, standards, guidelines and nomenclature.

There are 40 pharmaceutical companies in Nepal registered at the Department of Drug Administration (DDA) among which only 16 have been registered under GMP till date. DDA has started WHO-GMP certification for pharmaceutical industries, which have effectively implemented the WHO-GMP criteria and codes on manufacturing of drugs 2004.

Gorkha DC, pharmacist at Department of Drug Administration said that DDA has issued an order to pharmaceutical companies to meet GMP standards to maintain global norms, international standards and guidelines for quality, safety and efficacy of drugs, and is providing guidance in coordination efforts.

“Old pharmaceutical companies with outdated technologies and human resources, are finding it hard

to update to GMP standards,” said the pharmacist adding that new companies are obliged to register

under GMP before starting operation.

“DDA is not going to give license for new products if these companies fail to register within the deadline,” said Radha Raman Prasad, director of DDA. He informed that they could also halt medicine distribution of these companies. He further informed that action could be taken against these companies as per provisions in the regulation of medicine manufacturing, which is being drafted at present.