Written By: Nirmalya Dutta | Updated : July 24, 2014 11:21 AM IST
Major drug makers in the country including Sun Pharmaceutical Industries and Lupin have reacted strongly to the Indian government's recent 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 are set to approach 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.
Lupin said it was surprised that government decided to ban a drug which was being used in most major markets. 'This drug is in use in most advanced markets of the world, be it the US, Japan or the UK. I believe the DCGI has invited comments and responses from the industry and it should come up for review, which would be a very welcome step,' Lupin group president, India and CIS (Commonwealth of Independent States) Shakti Chakraborty told Business Standard. Pioglitazone is currently available in India under various brands such as Diavista by Dr Reddy's Laboratories, Sun Pharma's Pioglit and Pioglar by Ranbaxy Laboratories.
The drug commands a market of Rs 700 crore and a DCGI official admitted that a review is on the cards. 'The case is under consideration. We can review the order if the industry submits enough scientific evidence in favour of the drug,' said the official, who wished to remain anonymous.
In June, the government abruptly banned three drugs pioglitazone (a popular anti-diabetes drug), analgin (a painkiller) and deanxit (an anti-depressant) after it decided that the drugs posed a high health risk. It's believed that the government's decision was due to a commitment to a parliamentary standing committee that it would immediately suspend medicines not allowed for sale in major international markets.
But as the industry insiders correctly point out, the drug pioglitazone isn't banned in any of the aforementioned countries. We spoke to our expert Dr Rajiv Kovil, renowned diabetologist and the founder of the Diabetes Care Center, to find out more about the ban, and how it can affect patients.
Could you tell us why pioglitazone has been banned and is it a justified move?
Dr Kovil: It doesn't make any sense at all, because neither did the USFDA find any evidence to banpioglitazone, nor did the EMEA (European Medicines Agency). I for one do not understand where the health authorities in India found enough evidence to ban the drug and its combinations. There is no evidence across the globe sufficient enough to ban it.
The newspapers have reported that the drug is banned in the US, UK and Australia. Is that true?
Dr Kovil: That is not true. It has been banned only in France and certain parts of Europe. It was banned when the controversy about bladder cancer came up. It has been two years since then, and there has been a lot of clarity following those findings. Another factor that comes to mind are the findings about heart failure and pioglitazone. It has been almost six to seven years since then and there have been subsequent trials showing that there is no increase in the risk of heart failure, it is just that doctors should use the drug with caution in people who are at a higher risk of developing heart disease. Read more
