The Government of Kerala has banned the production and sale of the popular herbal aphrodisiac, ‘Musli Power Xtra’, being produced and marketed by Kunnath Pharmaceuticals, for violation of the provision of Rule 106 of the Drugs and Cosmetics Rules, 1945.
Rule 106 specifies that no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J. This Schedule includes, among other diseases, sexual impotency also. Kunnath Pharma has given wide publicity for their aphrodisiac product in print and visual media.
Government took the crucial decision to prohibit the drug under section 33 EEC of the Drugs & Cosmetics Act which empowers a state government to ban a herbal drug in certain cases, sources from the health ministry said.
The state government will also file a prosecution case against the Ernakulam based manufacturing company under Misuse and Improper use of Emblem Act as in the advertisement of the herbal product the company has reportedly used a picture that the managing director receiving an award from the President of India, sources from the health ministry told Pharmabiz.
Later while speaking to this reporter, KC Abraham, the MD of Kunnath Pharma said he was called to New Delhi previously by Rashtrapathi Bhavan sources to seek explanation from him for the use of the picture in the advertisement, and he assured them not to repeat it in future. He added that so far he did not get any information from the Kerala government banning his herbal drug.
According to section 33 EEC, from the date on which a state government notifies the prohibition in the official gazette, no person, either by himself or any other person on his behalf, can manufacture the product for sale or for distribution. Sources in the health ministry said government has banned the drug on April 2 and the notification has already been sent for official publication in the gazette.
The state Ayurveda drugs controller, N Vimala, said their department has received the prohibition order from the government and she would intimate it to Kunnath Pharmaceuticals today. The DC said the company is facing four cases in various courts with charges under Spurious Drugs Act and violation of Drugs and Magic Remedies (Objectionable Advertisement) Act,1954.
DMROA Act has been enacted with a view to control the advertisements of drugs in certain cases and to prohibit the advertisements for certain purposes of remedies alleged to possess magic qualities. Schedule J of the D&C Rules 1945 also deals with objectionable advertisements. The ADMROA Act also specifies the prohibition of advertisement for certain drugs, especially in the category of drugs described as aphrodisiac.
Besides the cases filed by the drugs control department, a Kochi based social organisation, ‘People’s Union for Civil Liberties (PUCL) has also filed a writ petition with the High Court of Kerala against Kunnath Pharmaceuticals for violation of DMROA Act 1954.
Earlier the drug authorities of Kerala had challenged the efficacy of Musli Power Xtra which claimed it had the potential to boost sexual power in both men and women and a reliable remedy for infertility related problems. Through wide advertisement in print and visual media, the company has been enjoying extensive sales all over the country and outside.
Sources in the health department said in the company’s website they have given obnoxious publicity to attract young men and women by giving the impression that the drug would increase the sexual passion. Further it has published fake feedbacks as positive experiences of consumers irrespective of their age.
Six months ago, the Delhi Institute of Pharmaceutical Sciences & Research (DIPS&R) had found that among five ayurvedic formulations marketed in the country by various manufacturing companies, Musli Power Xtra was adulterated and mixed with Tadalafil (phosphodies).
In one of the cases filed against the company, the charge was for change of ingredients. Initially, 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 (Chlorophytum Borivilianum) for which no licences had been given then. But later, Safed Musli was included in the pharmacopoeia and subsequently the company secured a separate licence as it is the main ingredient.