Centre raises Ayurvedic drugs normsThe 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).
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).
Bringing new policy change, the DDA has announced that it would now renew licenses of only those ayurvedic drug manufacturers who follow both WHO Herbal GMP and CPP guidelines now onwards.
According to the department, this provision will also be applicable for imported ayurvedic drugs.
DDA Director General Narayan Prasad Dhakal “The license of the manufacturers will not be renewed until they prove to us that they are adhering to the GMP and CPP guidelines.”
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.
To meet GMP guidelines, the manufactures must have their own microbiological lab inside their industry, which would cost them around Rs 4 to 5 million. They must have their own technical staff like lab technicians, doctors among others.
The AMPAN has also requested the DDA to draft ‘Ayurvedic GMP’ incorporating the opinions of both the manufacturers and government sectors concerning along with the traditional and cultural aspects as well.
“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.
“Better quality medicine for consumers is the major reason for making the GMP and CPP guidelines mandatory for the manufacturer,” said Dhakal.
While a majority of allopathic drugs manufacturers has acquired the GMP certification, only one ayurvedic drug company has such certification. Bhaskar Herbaceuticals is the only company currently producing Ayurvedic medicines in Nepal under WHO guidelines.