Is the recently suspended pain-killer analgin, set for a come-back into the market?
Late last month, analgin was suspended by the Health Ministry, along with diabetes drug pioglitazone and anti-depressant deanxit.
But after a recent review by the Drugs Technical Advisory Board (DTAB), the suspension on analgin too could be revoked, along with pioglitazone, say sources familiar with the development. A Health Ministry notification, possibly this week, will clear the air on the suspended medicines.
Pioglitazone was ordered off the shelf, following reports linking it to urinary bladder cancer. Analgin is said to cause bone marrow suppression, affecting its ability to make white blood cells, explain doctors.
The suspension of pioglitazone had triggered a hi-decibel reaction from the pharma industry and doctors, who said the drug was best suited for Indian patients. In contrast though, there was no open support from doctors or industry for the other two suspended medicines.
Doctors expect to get greater clarity, this week, on whether indeed pioglitazone will be back with a host of safety caveats, including a patient advisory similar to the black box warning system in the US and restrictions on new prescriptions, more stringent record keeping and sale of only smaller doses of the drug. Pioglitazone is an estimated Rs 700-plus crore market in India.
In comparison, analgin has a smaller market; industry estimates peg it at about Rs 50-odd crore. Popular earlier under the brand names Baralgan and Novalgin, doctors say the present market has analgin in tablet and injection forms, sold by players such as Sanofi and Alkem.