The Union health ministry's sudden decision to ban anti-diabetes drug pioglitazone has come in for severe criticism from the pharma industry in the country as the industry complains that the process of banning a drug was flouted by the ministry.

“There is complete secrecy and confusion about what led to banning the drug by the government which will adversely impact around 30 lakh patients who are using the drug at present,” Indian Pharmaceutical Alliance (IPA)'s secretary general DG Shah said.

Expressing the industry's ire over the issue, the industry leaders asked the government, is the decision to ban the anti-diabetes drug pioglitazone was taken to switch patients to new and more expensive drugs like gliptins marketed by the MNCs?.

The domestic industry's ire over the pioglitazone ban stems from the fact that the drug is available in a large number of countries in the world including the more regulated markets like USA, Japan, UK, Switzerland, Canada and Australia. The drug is also available in countries like China, Russia, Austria, Denmark, Mexico, Thailand, Italy, Spain, Hong Kong, Philippines, New Zealand, Sweden, Finland, Belgium, South Korea, Ireland, Malaysia, South Africa, Brazil, Argentina, Chile, Czech Republic, Greece, Norway, Portugal, Venezuela, etc. and in almost all these countries, pioglitazone has been there in the market for several years, and in some countries the drug has been in the market for more than a decade. The only major country where pioglitazone is banned is France.

The industry says that the ministry has the power to ban a drug under section 26-A of the Drugs and Cosmetic Act, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do.

However, in the response submitted by ministry of health to parliamentary committee, it is mentioned: "It has since been decided that whenever a drug is banned due to adverse drug reactions in countries with well developed and efficient regulatory system viz. USA, UK, EU, Australia, Japan and Canada, the manufacture, import and marketing of such drugs would be immediately put under suspension till the safety of the drug is examined and established in the country".

But the industry fumes that the contentious drug pioglitazone is not banned in any of these countries. Besides, any incidents of adverse drug reaction with this drug is not available in the country so far.