Officials in the Delhi Institute of Pharmaceutical Sciences & Research (DIPS&R) have confirmed that five ayurvedic formulations currently marketed in the country by various manufacturing companies are adulterated and mixed with sildenafil or tadalafil (phosphodiesterase) including Musli Power Xtra of Kerala. These five formulations, now available in the market, are combinations of allopathic and ayurvedic contents.
This was disclosed to Pharmabiz by the officials of DIPS&R in an email interview. According to sources, the institute has conducted investigations on 15 marketed preparations and of these, five were found to contain either sildenafil or tadalafil.
The products are ‘Supersonic’, manufactured by Renovison Exports Pvt. Ltd Federal, A&K Road, Patna , ‘Titanic K2’, manufactured by Sun Laboratories (P) Ltd. ORAI, UP, ‘Sikander e Azam’ , a product of Hashmi Unani Pharmacy, Amroha, UP, ‘2 Much Gold’ , manufactured by Prince Pharma, Village David, Ludhiana, and ‘Musli Power Extra’, of Kunnath Pharmaceuticals, Moovattupuzha, Kerala.
Sources from the government institute said they have collected the samples of the drugs from the local chemists in Delhi and they have the bills for the same for records. Their tests lasted for six months to find out the real contents.
“Earlier we wrote an official letter to the DCGI regarding the adulteration and in response to that, DCGI gave order to state drug controllers to take action on the same. We officially received letters from state drug testing laboratories where they have demanded the standards for testing of these products and in fact asked for the method of analysis employed in our laboratory. We received such letter from Rajasthan state drug testing laboratory”, an official in the institute said.
When asked what kinds of ingredients their tests targeted and how many of them proved positive, the official replied that they had targeted sildenafil and tadalafil.” We investigated 15 marketed preparations and of these, five were found to contain one of the mentioned drugs”.
They said the method used for conducting the analysis test of the formulations are various types including the latest one by using HPTLC, HPLC and LC-MS instruments.
In the quantitative test using the above instruments it was found that all the five products were contained the ingredients of phosphodiesterase (sildenafil or tadlafil) with different quantities in mg per tablet or capsule.
In the drug ‘Supersonic’ (batch NO- 14) the sildenafil presence per tablet/capsule was ‘119.00 mg. In ‘Titanic K2’, (Batch No—27), it was 71.00 mg per tablet/capsule. Where as, in ‘Sikander e Azam’, (Batch No—2), the presence of sildenafil per tablet/capsule was 76.00 mg.
The same content was also found in the drug, ‘2 Much Gold’,( Batch No—152), and the quantity was 2.01 mg per tablet/capsule. In ‘Musli Power Extra’, (Batch No--MP/058/09 ) the ingredient found was tadalfil and the amount present per capsule was 32.00 mg.
The officials said herbal medicines rarely have a quick onset of action and it is often seen that they produce mild to moderate action. Furthermore they elicit their response on prolonged dosing. The manufacturers of these companies were claiming to cure the problem of erectile dysfunction with single dose. This was contrary to the popular belief about the herbal drugs and that is what prompted them to carry out research to find out the truth behind their claims.
DIPS&R has sent the reports to the DCGI and copies were sent to the CDSCO offices and also to the health ministries of central government and Delhi government. It has advised the concerned authorities to conduct strict pharmacovigilance of these herbal products and they should be prohibited from marketing openly to public.
As per the Drugs & Magic Remedies Act “any such product used for the cure of sexual dysfunction cannot be advertised”. But manufacturers of these products are advertising on a large scale.