18 March 2012
By Umesh Isalkar
FDA Bans Sale Of Medicine
The Drug Control Laboratory has detected the presence of tadalafil, an allopathic drug used for the treatment of erectile dysfunction, in a particular batch (B No. H–P–M–04) of ayurvedic capsules sold under the name Hypower Musli. Tadalafil is a prescription drug and could pose serious health hazards if used without medical supervision.
A particular batch of another ayurvedic product sold under the name Powerful Powder (B No. 001) was found to contain diclofenac sodium and prednisolone (a kind of steroid) — both allopathic prescription drugs used to treat all kinds of arthritic pain and inflammation. According to Ayurveda experts, Hypower Musli capsules are used as an ayurvedic medicine to enhance sexual power while the Powerful Powder is an ayurvedic physical fitness enhancer.
These are two of the 27 medicines, particular batches whose sale has been prohibited by the Food and Drug Administration (FDA), Maharashtra, due to substandard quality and for violating various provisions of the Drug and Cosmetic Act 1940 and rules 1945.
“As many as 25 of the 27 drug manufacturers, who faced action, are from outside Maharashtra. The two from the state were in Thane and Nagpur. We have asked the respective state’s FDA to take appropriate action against them,” FDA joint commissioner B R Masal told TOI on Thursday.
Masal said the two drug manufacturers in Maharashtra have been asked to withdraw the particular batches of medicine found unfit and substandard from the market.
“The FDA authorities of other states have also been told to ask the erring manufacturers in their region to withdraw products found substandard. Besides, government hospitals, medical colleges attached to hospitals and doctors’ organisations have also been informed about the names and batches of the drugs, which have been banned for sale in Maharashtra,” he said.
The chemists and druggists associations are now supposed to warn their members and retailers against selling the particular batches of medicine banned by the FDA, Masal said.
Physician Abhijit P Joshi of Joshi Hospital said tadalafil causes dilation (expansion) of the blood vessels. “If a person is hypertensive or has kidney problems, a dose of tadalafil taken without doctor’s advice can worsen his or her medical condition. For people in good health, some of the common side–effects are headache and facial flushing,” he said.
Diclofenac sodium and prednisolone found in the other ayurvedic product that has been banned by the FDA can cause gastric and kidney problems, osteoporosis, hypertension and worsening of heart disease when taken over a long period of time without consulting the doctor, Joshi said.
TOI has a copy of the list of drugs that the Drug Control Laboratory has reported to be of substandard quality. Samples were taken for analysis from different destinations in Maharashtra in January and declared not of standard.
“We advise people against using particular batches of these medicines,” said Ravi Joshi, assistant commissioner (drugs), FDA, Pune.
When contacted, Powerfull Powder’s manufacturer Siddhi Herbal located in Butibori MIDC Nagpur refused to comment anything on the FDA action.
Amrut Nikhade, acting joint commissioner, FDA, Nagpur, said, “A criminal case will be filed against the Powerfull Powder’s manufacturer once we get the consent from the FDA headquarters. The product was seized before it was pressed into the market on mass level. The manufacturer had put the product for sale at one of his relatives’s outlet from where we took the sample and later seized the complete batch.”