Uncertainty over the fate of the oral anti-diabetes drug Pioglitazone, banned from the market late last month, is likely to be lifted soon, following a meeting of the Drugs Technical Advisory Board (DTAB) on Friday.
According to sources, there was consensus at the meeting to revoke the ban, which many in the industry felt was imposed without significant evidence or proper studies to establish the drug’s negative effects.
The market for Pioglitazone in India is estimated at Rs 700 crore annually and major players, such as Ranbaxy, Cipla and Sun Pharma, manufacture the drug.
The Ministry of Health and Family Welfare had decided to suspend the drug because of suspicions linking its long-term use to urinary bladder cancer.
The drug was banned in France three years back, but continues to be used in the US, the UK and other countries, albeit with a warning label.
It is likely the Board will recommend bringing the drug back to the market, though with a warning label, such as the ones used in the US and Europe, cautioning patients on the likely health effects in the long term.
The final decision is expected to be announced by the Health Ministry on Monday.
However, members of the industry say the drug is used in low doses in India and is better suited for the Indian population.
“Suspension (of the drug) was done without any evidence and the Ministry of Health will have to correct the situation,” D. G. Shah, Secretary-General, Indian Pharmaceutical Alliance, said.
However, given that France had banned the drug three years back, an industry representative also questioned the logic of suspending Pioglitazone after such a long time.
The industry insider added that due process was not followed in taking steps to suspend the drug in the country.