Joseph Alexander, New Delhi
‘Musli Power Extra’ of Kunnath Pharmaceuticals, which is already facing a couple of cases filed by the Kerala state drug control authorities, is found to be adulterated and admixed with ‘Tadalafil’ (phosphodies) in an official study engaged by the authorities, spelling more trouble for the company.
The study was conducted in the Department of Delhi Pharmaceutical Science and Research University to find the facts behind the claims made by the manufacturers of the medicines for the treatment of sexual dysfunction. The study also wanted to make people aware of the serious side effects of the Schedule H drugs such as sildenafil and tadalafil, which includes Photophobia, dyspepsia and severe hypotension which can lead to coma and even death. “The study has revealed that ‘Musli Power Extra’ manufactured by Kunnath Pharmaceuticals of Kerala, Batch No. MP/058/09 was adulterated/admixed “Tadalafil” (Phosphodies) in amount of 32 mg/tablet/capsule,” sources said.
The issue of Kunnath Pharmaceuticals manufacturing the product was discussed in detail in the meeting of Ayurveda Siddha Unani Drug Consultative Committee recently. The committee advised that, Kerala Licensing Authority may recommend to the Central Government for withdrawal/cancellation of the drug license by the Central Government under section 33 EED of Drugs & Cosmetics Act 1940.
The firm is also violating the provisions of the Drugs and Magic Remedies (objectionable advertisement) Act 1954. This also brings a bad name to the age old systems of Ayurveda. It was also agreed by the committee that all the State Licensing Authorities may issue notices and should initiate legal action against the marketing of this product in various states, sources said.
The Drugs Control Directorate of Kerala had already filed two cases against Kunnath Pharmaceuticals with the Chief Judicial Magistrate Court at Moovattupuzha on June 22. The action against the pharmaceutical company came because of violation of provisions under the Drugs & Cosmetics Act and Rules by the company for the last several years until the illegal practices were detected last year. The cases were filed under Spurious Drugs Act, and under Drugs and Magic Remedies (objectionable advertisement) Act, 1955.
The approval granted for production of ‘Musli Power Xtra’ formulation, the main ingredient indicated was the seed of ‘Nilappana’ (Curculigo orchioides), but the company made the product with the extracts of Safed Musli for which no licence had been given, according to the Kerala drug authorities.