The Drugs Control Directorate of Kerala Government has filed two cases against Kunnath Pharmaceuticals, the manufacturer of Musli Power Xtra in Kerala, 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, according to sources from the department.

The cases that were filed include, one under Spurious Drugs Act, and another one under Drugs and Magic Remedies (objectionable advertisement) Act, 1955, said M Geetha, the state drugs controller.

According to sources in the department, in 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 drug with the extracts of Safed Musli for which no licence had been given.

At the time of applying, Safed Musli was not contained in the Indian pharmacopoeia. Besides, as per D&C Act, the extracts of raw drugs cannot be used for making any kind of formulations. So, under spurious drugs act, a case was filed against the company. 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.

The drug inspector of Ernakulam zone said recently it was included in the pharmacopoeia, and subsequently the company has secured a new licence indicating Safed Musli as the main ingredient.

While the Drugs and Magic Remedies (objectionable advertisement) Act clearly specifies the prohibition of advertisement for certain drugs, especially in the category of drugs described as aphrodisiac. According to Ernakulam drug inspector, Kunnath Pharmaceuticals had given extensive publicity for the product claiming its power in increasing the potency of men and women. So a case against the violation of this Act was also taken.

The inspector said that the state drug authorities had warned the company not to advertise or put on label the term ‘aphrodisiac’ directly or indirectly with any other word or phrase to attract people. But the company had been giving extensive publicity for the product substantiating its power in increasing the potency of men and women.
Based on some complaints and media reports, in December last year, an inspection team led by former Drugs Controller M P George conducted raids in the company’s godowns and factory and seized stocks of Musli Power Xtra worth over Rs 27 lakh. Some of the seized stocks were produced in the court and 600 cases of the drug were withdrawn from movement, said, Smart P John, senior drug inspector at Thiruvananthapuram. He said the company was manufacturing spurious drugs at the time of inspection.

The drug inspector who conducted inspection at the factory said, the use of Safed Musli for the production of the drug was a digression of what is given in the formula approved by the department. The company was buying the extracts of the Safed Musli from Elixir Extracts Pvt Ltd, Moovattupuzha. He said the punishment for this violation involves three years imprisonment and a fine of Rs 50,000.