Presence of microbes in some Ayurvedic products is high, drug regulatory body saysManufacturers argue the protocol enforced by the regulator is too strict.
The Department of Drug Administration’s new rule has put Ayurvedic drug manufacturing companies in a quandary.
Last week, representatives of Ayurvedic drug manufacturing companies reached out to the department to request leniency in the rule because they were unable to send their products, especially churnas (powder drugs) to the market, as they failed to maintain the standard set by Ayurvedic Pharmacopeia of India.
Ayurvedic medicines in Nepal are produced under Ayurvedic Pharmacopeia of India, which has defined microbial contamination limits. Permissible limits for herbal extracts and powder for Staphylococcus aureus, Salmonella sp, Pseudomonas aeruginosa, Escherichia coli are zero, according to Ayurvedic Pharmacopeia of India.
Similarly, the permissible limit for total microbial plate cunt should not exceed 10^5 per gram and total yeast and mould should not exceed 10^3 per gram.
According to the Department of Drug Administration, most of the churnas produced by national and international companies have failed the microbial test.
Presence of hazardous pathogens-E coli, Salmonella and other deadly microbes that cause gastrointestinal infection, urinary tract infection respiratory infection and others were found in churnas produced by different companies.
“It’s not a new protocol. Nor is it the standard set by our office,” said Narayan Dhakal, director general of the Department of Drug Administration. “This protocol is set by Ayurvedic Pharmacopeia of India under which Nepali Ayurved drug companies manufacture the medicines. We are not against their products but they should ensure the hygiene of the products.”
According to Ayurvedic drug manufacturers, they have not been able to send some of their products to the market.
Prior to their meeting with officials of the drug office, the representatives of drug companies had met with Minister for Industry, Commerce and Supply Matrika Prasad Yadav, Minister for Finance Yuba Raj Khatiwada, and Prime Minister KP Sharma Oli to draw the leaders’ attention to the problems they are facing.
“With our products failing the test as per the new protocol, our investments of millions of rupees are at risk,” said Dilli Prasad Ghimire, chairman of Ashtanga Pharmaceuticals Pvt Ltd.
Officials at the Department of Drug Administration, which is the national regulatory body of drug market, say they had asked manufacturers to abide by the protocol to ensure the safety of the general public.
Drug inspectors, according to the officials, have also filed reports of poor hygiene condition of ayurvedic drug manufacturing companies, poor storage of raw materials, and presence of rat stool, spider and lizard in the storerooms.
“Our concern is that no one using these [Ayurvedic] medicines should fall sick or afflicted with new diseases,” Dhakal, the director general, told the Post. Manufacturers, however, say the authorities should pay heed to their concerns while trying to enforce the standards. “We are committed to meeting the quality standard,” said Suman Pandey, chairman of Aarogya Bhawan Works Pvt Ltd. “We will upgrade our factories but the Department of Drug Administration also needs to pay heed to our concerns.”