The presence of synthetic material in herbal drugs for erectile dysfunction, which is alarmingly high in some Asian countries like China, has a miniscule presence in India. Only one out of a total 54 branded herbal products is found to have high presence of the chemical - sildenafil, according to a study.
The study conducted by a group of researchers in National Institute of Pharmaceutical Education and Research (NIPER) found that one product out of 54 branded herbal drugs for erectile dysfunction contains 72.5 mg of seldinafil in a single dosage whereas the label does not mention about the synthetic material and has been marketed as a pure herbal product. The research report was presented as a scientific paper in the 60th IPC held recently in New Delhi.
Sildenafil is an ingredient in Pfizer's renowned aphrodisiac product Viagra, which is marketed in India in two strengths - 50 mg and 100 mg. Though the study has identified one more drug with synthetic content in the same category, the presence of chemicals was detected only in one batch in the batch to batch study.
The study was conducted on aphrodisiac herbal formulations collected from various parts of the country through an HPLC method developed for sildenafil and tadalafil which are approved by the drug regulator in India for use in modern drugs. The formulations were analysed using a gradient HPLC method after simple extraction and the adulteration was detected by comparing the relative retention times and UV spectra in each case with the standard.
Even though the revelation that the use of synthetic material in herbal formulations in the segment is miniscule when compared to products from other countries, the presence of even a single such product in India has to be checked, added Dr Saranjit Singh, dean, NIPER who lead the research team.
"It is a positive signal that there is only a little presence of counterfeit herbal drugs in India in this category. However, we will apprise the Drug Controller General of India (DCGI) of the issue to prevent such events becoming a trend in India as is the case in some other countries," Singh averred. However, he refused to reveal any details on the particular product, saying that the information would be handed over to the DCGI if he calls for it.
"We have to send a message to the manufacturers of such products that with the latest LC and LC-MS based techniques, detection of adulteration by synthetic drugs of herbal formulations is easy," he added. The group is planning to extend the study to products sold by practitioners and quack herbal doctors in rural India to gauge the presence of such products in the segment. The study is in the final stage of preparation and will be published in a scientific journal soon.
The research group from NIPER includes Savaliya A A, Shah R P and Prasad B apart from Dr Saranjit Singh.