Aug 4, 2018-The Department of Drug Administration (DDA) has made it mandatory for ayurvedic drug manufacturing companies to follow both World Health Organization (WHO) Herbal Good Manufacturing Practices (GMP) and Certificates of Pharmaceutical Product (CPP).
According to Ayurveda Medicine Producer Association of Nepal (AMPAN), there are 80 ayurvedic drug manufacturers registered in the DDA, of these only 36 are in operation whereas nearly two dozen have applied for GMP certification.
The WHO GMP is that 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.
On the other hand, the CPP is a certificate issued to those manufacturers that establishes the status of the pharmaceutical product in order to export to other countries.
The AMPAN has said it would be difficult for them to meet the international standards of GMP in the manufacturing process, owing to its high cost. AMPAN Chairman Binod Poudel said, “Following all GMP guidelines is very expensive. It could cost around Rs 50 to 70 million. We are in talks with the Health Ministry on revising the GMP process.
“Editing the GMP standards would allow both sectors – government and the manufacturer – to have their opinions which will allow the entire manufacturer to meet the guidelines in an affordable manner,” said Poudel, adding, they are getting opinions from manufacturers around the country.
The DDA, focusing over the health of the consumers, has said that it will be monitoring the manufacturer’s product over the guidelines to ensure it is a quality product.
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