As per a notification issued by the Union Health Ministry, the suspension imposed on the diabetes drug Pioglitazone and all its combinations has been repealed.
Why Pioglitazone was banned earlier?
Under the Drugs and Cosmetic Act 30-B, sale of any drug, the use of which is prohibited in the country of origin, is banned in India until clinical data substantiate that it is risk free. There are several health risks involved with Pioglitazone. Though it is generally used in against type 2 diabetes and hyperglycemia, there has been higher occurrence of fractures hands and feet in female diabetics given this drug and is also associated with bladder cancer and congestive heart failure as found in some Western studies.
What are the new guidelines for the sale of Pioglitazone?
The Drug Technical Advisory Board (DTAB) has recommended that the drug may be allowed to be sold and consumed in the country, with sufficient caution. It suggested that the manufacture and sale of Pioglitazone may be allowed, provided the manufacturer clearly mentions on the package insert and promotional literature of the drug that Pioglitazone may not be used as a first line of therapy for diabetes. It has also recommended that the manufacturers carry a box warning, clearly mentioning the risks/side effects of the drug in bold red letters on the package. It has also asked the doctors to make sure that the drug is not used in persons with active bladder cancer or a history of bladder cancer in the family. Doctors should review the safety and efficacy of the drug after three to six months of prescription and the drug maybe continued only if the patient seems to be deriving any benefit.