Bacterial contamination in lagundi cough products

The government program has been actively promoting the use of indigenous herbs with medicinal properties. The Department of Health (DOH) has approved 10 medicinal plants as source of products that could treat common ailments in the country. These 10 are akapulko, ampalaya, bawang, bayabas, lagundi, niyog-niyogan, sambong, ulasimang bato, tsaang gubat and yerba buena.

The National Integrated Research Program of the Medicinal Plants  (Nirpromp) of the University of the Philippines Manila is at the forefront of researches on these medicinal plants and local drug companies usually seek its assistance in coming up with the right formulation process for these herbal preparations.

In previous columns, we have supported this program as a means of providing affordable, effective and safe medicines that can treat common medical problems encountered by Filipinos.

Warning

However, lately, we must have all heard of the commercial on radio and television wherein the celebrity host warns the public of significant bacterial contamination of some anti-cough lagundi products. I know that this was a problem being encountered in other underdeveloped countries like Nigeria and Africa, but I was quite confident that our local FDA is much more stringent in ensuring that GMP (Good Manufacturing Procedure) is followed by all manufacturers of these medicinal pharmaceutical products.

All manufacturers must get a GMP certification from the FDA before they could be allowed to manufacture any product. GMP provides strict measures to ascertain that the plant materials are subjected to optimum pharmaceutical quality assurance to prevent bacterial and fungal contamination and that the active ingredients extracted from the medicinal plant could be preserved over a period of time for sustained effectiveness of the herbal product.

The TV commercial got my interest and I looked at the laboratory data being referred to by the celebrity host, and see whether his claim was valid or not.

Random sampling

Samples of these lagundi products were bought at random from local drug stores and were sent in sealed packages to an independent laboratory for analysis. They were subjected to a “microbial limits test”  or MLT based on the United States Pharmacopeia (USP), which  is an official global standards setting authority for medicines and food ingredients. The MLT is a form of bioburden testing that determines the presence of aerobic bacteria, yeast, molds and other specific bacteria such as E. coli, salmonella and other known harmful microbes.

The Philippine FDA standards are based on USP-set recommendations although our local FDA has set relatively higher threshold limits for bacterial presence in medicinal products compared to USP standards.

Samples of the lagundi products were placed on petri dishes and after a period of incubation, they counted the number of bacterial colonies, expressed as number of colony-forming units per gram or CFU/g.

The results showed that two of the lagundi cough remedies tested were above DOH-FDA threshold for permissible bacterial CFU/g. If the more stringent global standards based on USP is followed, one more exceeded the acceptable limit of bacterial count. In fairness though, majority of the samples tested (15 out of 18) had bacterial counts lower than the FDA-set threshold.

Potential public hazard

I’m sure the problem has already been referred to our FDA, which should address the problem promptly. If the laboratory results are valid, it can be a potential public hazard that could cause a variety of problems including diarrhea, vomiting, abdominal cramps and dehydration. Other serious infections may also be caused particularly in people with low resistance or compromised immune systems. These include children, the elderly, pregnant women and those positive for HIV.

Notorious among the aerobic bacteria that could be present in medicinal plant products is Salmonella, a highly pathogenic bacteria that has been known to infect plants cells and successfully evade all the defense mechanisms of plants. It can also survive for up to 900 days in contaminated soils, which can make it a real source of infection for medicinal plants. The contamination of these cough preparations with harmful bacteria might be due to the use of manure to fertilize the medicinal plants used as raw materials for the products.

‘Unfit for human consumption’

When asked how clinically significant these findings are, a local infectious disease specialist commented that the cough preparations which flunked the MLT should be considered “unfit for human consumption.”

Foreign scientists have also warned that bacterial contamination of syrups and suspensions medications can adversely alter the product and “constitute direct health hazard to the patients due to the metabolic versatility of bacteria in which almost any formulation ingredient, from simple sugars to complex aromatic molecules, may undergo chemical modification by a suitable organism.” (Takon and Antai, 2006)

This finding should not be a reason to go slow on the government’s program to promote indigenous medicinal plants. Hiccoughs like this occur in any undertaking. When properly addressed and corrected with more stringent adherence to GMP, it can be a blessing in disguise that can ultimately boost the local herbal industry. If ignored, it can be a potential source for real big medical nightmares of epidemic proportions.