Anti-diabetic drug pioglitazone, which was controversially banned by the health ministry some time ago, is likely to make a comeback in pharmacies soon. Sources told TOI that the government decided to revoke the ban after meeting a group of doctors who told the ministry that there was no affordable alternative to the drug for millions of diabetics in India. It's believed that a formal declaration will be made in a week. Till then the ministry will ask pharmaceutical companies to print a warning on the packages. It's believed that some doctors were still opposed to the drug saying it caused bladder cancer while others explained that there was no alternative diabetes management system.
'Most doctors wanted the drug. So, we will reintroduce it. But it will be sold with a warning that high doses can cause bladder cancer. We expect doctors to inform patients about its risk,' said a senior health department official. 'We will send the report to the health minister and then to the drug technical advisory board,' he said.
Read: Was the drug banned to appease big pharma?
Many doctors had earlier argued that the pioglitazone ban on the grounds that it causes bladder cancer was based on studies conducted in the Western world and there was no scientific evidence to back it up that a similar fate awaited Indian users.
Pioglitazone controversy timeline
Jun 27: Health Ministry bans pioglitazone along with analgin and deanxit
The decision came in the wake of the government's stand on suspending drugs which are prohibited in leading markets like the US, UK, European Union and Australia. The health ministry has suspended the drugs under Section 26A of the Drugs and Cosmetics Act, 1940. The ministrywas deemed to be indecisive about banning analgin and deanxit for years now and a Parliamentary Standing Committee had pointed out that despite being banned in most markets they were still available in India. Dr Rajiv Kovil a renowned diabetologist tells us why the ban on pioglitazone is a bad idea.
Jun 28: Health Ministry's ban draws ire from all corners
The Union Health Ministry's decision to ban anti-diabetes drug pioglitazone comes in for sharp criticism from the pharma industry in the country. Indian Pharmaceutical Alliance (IPA) secretary general DG Shah said, '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.' Some even believe that this move is calculated which will force patients to consume more expensive drugs like gliptins.
Jul 3: Pharma companies demand review of suspension order
Major drug makers in the country including Sun Pharmaceutical Industries and Lupin react to the Indian government's move to ban the popular anti-diabetic drug pioglitazone and they claim that the medicine was banned without adhering to the popular consultation process with the Drug Technical Advisory Board (DTAB) or the pharma companies.
Armed with scientific data, members of the pharma industry approaches the Drug Controller General of India to ask them to review the suspension order failing which the industry will consider legal options. 'We are demanding a review. A ban has to be based on science and scientific data. It has to follow a proper process and be evaluated by the DTAB and with the knowledge and consultation of the industry,' said Indian Pharmaceutical Alliance secretary general D G Shah.
Jul 12: Unofficial sources suggest ban will be revoked within a week
