Govt fails to bring Ayurvedic drug manufactuers under GMP purview
Kathmandu, November 3
It is mandatory for all pharmaceuticals companies of Nepal to receive a certificate of Good Manufacturing Practice standards. However, only one out of 77 Ayurvedic medicine manufacturing companies has received the certificate so far.
The Department of Drug Administration initially implemented the WHO’s GMP standards in 2004 and later it introduced its own GMP standards in 2015 to maintain quality of drugs manufactured by pharmaceuticals in the country. Even after the standards were amended, the government has failed to bring Ayurvedic medicine manufacturers under the purview of GMP standards. The GMP covers areas like production, distribution and supply of drugs.
DDA lacks equipment to check combination of ingredients used in Ayurvedic medicines. Staffers at the department have to visit factories to check the combination of ingredients.
Officials at DDA said they were often tricked and misguided by medicine manufacturing companies. “DDA authorities could never be assured of the quality of raw materials manufacturing companies use even if they could find out the quantity of ingredients used,” DDA officials said.
DDA has been checking the quality of Ayurvedic medicines on the basis of its own National Production Guideline of Medicine Act, 1978 and Medicine Registration Regulation, 1981.
Mandatory microbial and heavy material tests are done after medicine packaging. As many as three private laboratories in Nepal are given permission for these tests.
President of Ayurveda Doctors Association and Ayurvedic physician Dr Shyam Mani Adhikari said, “The biggest challenge we are facing is that we are not able to ensure the quality of raw materials, even though we check the amount of ingredients used in medicines.”
Extracted ingredients like oil removed cloves and aroma extracted sandalwood and low quality raw materials are found used commonly in Ayurvedic medicines.