The Eranakulam-based Kunnath Pharmaceuticals, manufacturer of Musli Power Xtra, has approached the Ayurvedic Drug Control office in Thiruvananthapuram for a fresh licence for manufacturing the product with a formula including Safed Musli.

Previously the company was manufacturing the medicine without proper licence for a formula including Safed Musli (Chlorophytum Borivilianum). Now the Ayush department has included Safed Musli in the Indian Pharmacopoeia.

“The application is with me. The expert committee will look into the rationality of the combinations and the genuineness of the references prescribed in the application, and everything being equal, the licence will be issued in due course,” said Dr D Sivadas, drugs controller, Ayurvedic Division.

Last month, the Ayurvedic drugs control wing in Kerala has given oral stop order of the product after an inspection at the company’s factory at Moovattupuzha and had initiated action for violation of provisions under the Drugs & Cosmetics Rules. The drugs control department has already processed action against the company as per the norms of Drugs and Magic Remedies (objectionable advertisement) Act, 1955, sources in the department told Pharmabiz.

Earlier the drug inspector in Eranakulam had told Pharmabiz that the approval for the production of Musli Power Xtra had been 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.

According to 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.

According to sources in the drugs control department, Kunnath Pharmaceuticals was manufacturing and marketing the product, Musli Power Xtra, claimed to treat infertility in both men and women and has been giving wide publicity through print and electronic media. It is still going on despite the departmental action, they said.

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.