The Drug Technical Advisory Board (DTAB), scheduled to meet on July 19, will review the ban of three drugs including anti-diabetes drug pioglitazone and recommend on whether to roll back the ban in the light of the evidences collected by the Central Drugs Standard Control Organisation (CDSCO).

The CDSCO which held a series of meetings on the issue, especially on the anti-diabetes drug, has also collected feedbacks from the industry to place them before the DTAB, the highest decision-making body on technical matters related to manufacturing and regulation of pharmaceutical products.

Sources said the issue would be included on the agenda, but it was still not known whether a final decision would come in the case of banned drugs. “The DTAB will review all the three cases based on the evidences so far,” sources said.

In the case of pain-killer analgin and anti-depressant deanxit, the regulatory authorities do not want to lift the ban as both were banned in several countries and there was also huge pressure from the Parliamentary standing committee which accused the CDSCO of dragging the feet on the issue, it is learnt.

However, the health ministry is open in the case of pioglitazone and would be ready for the review. Pending the review, it can be placed under suspension instead of ban and the DTAB may constitute a sub-committee to go into the issue, sources indicated.

The Ministry has now adopted a stand that if a drug is banned in the developed countries, it would be banned in India till its efficacy and safety is proved in the interest of the general public. Based on this stand and in the wake of a couple of adverse reports, pioglitazone was banned along with the two other drugs.

In a recent meeting with the stakeholders, the authorities had made it clear that the government was not adamant on the issue and would consider rolling back the ban based on the scientific evidence to be collected.

Unlike in the case of anlagin and deanxit, the industry had raised concern about the ban of pioglitazone which has a market of about Rs. 700 crore with major companies like Lupin, Sun Pharmaceutical Industries, Dr Reddy’s Laboratories and Abbott Laboratories manufacturing the drug in various combinations.