Drug regulatory authorities in south Indian state of Kerala has moved court challenging the efficacy of Musli Power Xtra – one of the widely popular herbal medicine with claims to boost sexual prowess in both men and women.
The cases that were filed include, one under Spurious Drugs Act, and another one under Drugs and Magic Remedies (objectionable advertisement) Act, 1955.
Inspectors from the Drugs Control Directorate of Kerala Government has been warning Kunnath Pharmaceuticals, the manufacturer of Musli Power Xtra in Kerala, against illegal promotion of the herbal product flashing labels that it is an aphrodisiac while the claims are not scientifically validated.
The state drug authorities had warned Kunnath Pharmaceuticals not to advertise or put on label the term ‘aphrodisiac’ directly or indirectly on Musli Power Xtra with any other word or phrase to mislead people.
Despite this, Kunnath Pharma continued giving wide publicity through promotional advertisements claiming that Musli Power Xtra has the potential to increase the sexual prowess of both men and women and can be even a reliable remedy for infertility related problems.
Musli Power Xtra is currently enjoying extensive sales not only across Kerala but in other places across India as well as abroad, sources said.
However, Musli Power Xtra has been using a different ingredient for the licence was not granted and is illegally promoted for indications which has been approved, drug department said.
According to the drug officials, the approval granted for production of Musli Power Xtra formulation, the main ingredient indicated was the seed of ‘Nilappana’ (Curculigo orchioides), but Kunnath Pharma made the formulation with the extracts of diffrent plant called Safed Musli for which no licence had been given.
Kunnath was using extracts of raw Safed Musli which is violation of the provisions of the Drugs & Cosmetics Act which clearly states such raw ingredients cannot be used for making any kind of medicine formulations.
Moreover, the herb Safed Musli was not included in the Indian Pharmacopoeia – the authorised mannual specifying standards of raw materials in medicinal products –at the time of granting licence for Safed Musli.
Kunnath Pharma, however, secured a licence for using Safed Musli as a raw material to produce Musli Power Xtra subsequently following the inclusion of the herb in Indian Pharmacopoeia.
Therefore, the state drug regulator has booked Kunnath under Section 33 EE A (d) of D&C Act says any drug which has been substituted wholly or in part by any other drug or substance could come under the provisions of Spurious Drugs Act.
A second lawsuit has also been initiated against Kunnath Pharma with the Chief Judicial Magistrate Court at Moovattupuzha for promoting Musli Power Xtra with the proclaimed label as “aphrodisiac” for increasing sexual potency in both men and women stating that such is claim is a clear violation of the Drugs and Magic Remedies (objectionable advertisement) Act.
The Act clearly specifies the prohibition of advertisement for certain drugs, especially in the category of drugs described as aphrodisiac.
Drug authority of Kerala raided the factory godowns of Kunnath Pharma for illegal manufacturing practices last year following complaints from consumers and media reports,and seized stocks of Musli Power Xtra worth over Rs 27 lakh.
The seized stocks were produced in the court and 600 cases of the drug were withdrawn from the market, reports said quoting senior drug officials.
The punishment for illegal promotion of Musli Power Xtra can involve upto three years imprisonment and a fine of Rs 50,000, experts said.