The ISM Wing of Directorate of Drug Control of Kerala will be issuing an order to stop manufacturing and marketing of Musli Power Xtra by Kunnath Pharmaceuticals in Ernakulam for violation of provisions under the Drugs & Cosmetics Rules for the last few years. The proposed action follows an inspection of the company’s factory at Moovattupuzha last week.
The ISM Wing is also processing action against the company as per the norms of Drugs and Magic Remedies (objectionable advertisement) Act, 1955, it is learnt.
The ISM action is subsequent to complaints received from public including leading Ayurvedic doctors against the company alleging manufacture and sale of spurious drugs, said Dr P Y John, drug inspector at the Eranakulam zone of the ISM wing, who conducted the inspection of the company’s factory. The Company has been given an oral stop production order as soon as the anomaly was found, and the zonal office has written to the directorate for stringent action, said the drug inspector.
When contacted, Dr D Sivadas, drugs controller for ISM wing confirmed that the action would be initiated in a few days and the process is on.
The drug inspector said that Kunnath Pharmaceuticals was manufacturing and marketing the product, Musli Power Xtra, claimed to treat infertility in both men and women throughout India and outside by giving wide publicity. The product was said to be formulated from Safed Musli (Chlorophytum Borivilianum) known as Indian herbal aphrodisiac. The company was charging Rs 750 for a bottle containing 30 capsules and Rs 1500 for a bottle of 60 capsules. He said the company had claimed that a capsule a day could boost the fertility among people.
According to the drug inspector, the approval for the production of Musli Power Xtra was given for a formulation in which the main ingredient indicated was the seed of ‘Nilappana’ (Curculigo orchioides). But the company was producing the drug with Safed Musli for which no licence was given to the company as it was not contained in the Indian pharmacopoeia at the time of issuing the licence.
He said that as per the section 33 EE A (d) of D&C Act, 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 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.
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 has been giving extensive publicity for the product substantiating its power in increasing the potency of men and women.
The official said that on inspection of the Batch Manufacturing Record (BMR) at the factory it was found that the company’s use of Safed Musli for the production of the drug was a digression of what is given in the formula approved by the department. They were 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.
When contacted, Dr K C Abraham, managing director of Kunnath Pharmaceuticals, said that there is no need of separate licence for manufacturing ayurvedic drugs and he got the licence from the authorities years before. Dr John also said that the managing director of the company is neither a qualified person nor has any degree in any discipline.