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DTAB recommends Health Min to revoke ban on pioglitazone
Joseph Alexander, New Delhi | Monday, July 22, 2013, 15:20 Hrs  [IST]

With the Drugs Technical Advisory Board (DTAB) deciding against the ban of anti-diabetes drug pioglitazone, the Union Health Ministry will formally lift the ban on the drug any time now.

It is learnt that a recent meeting of the DTAB, the highest technical panel on regulatory affairs, took note of the apprehensions and went through the evidences to revoke the ban on the drug, which had created lots of confusion and drawn flaks from the industry.

The DTAB which met on Friday had taken the decision in principle and the recommendation was made to lift the ban on the drug and as per this, the Health Ministry is expected to issue the notice any time. The drug may be advised to be marketed with a warning, it is learnt.

The ban on the drug had invited sharp criticism from the industry which felt that the action was taken without sufficient studies. 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 CDSCO had held a series of meetings on the issue to collect feedbacks from the industry. The DTAB went through the inputs in the meeting.

The Health Ministry had put a ban on the drug on the ground that it was already banned in France and in Germany and there were some adverse reaction reports from India itself. Besides, the Ministry also took the stand that if a drug was banned in the developed countries, it would be banned in India also till its efficacy and safety is proved in the interest of the general public.

However, the Drug Controller General of India (DCGI) Dr G N Singh had also clarified that the Government has an open mind in the case of pioglitazone as the ban would be lifted based on the scientific evidence and expert recommendations.

Comments

Arvind Nag Jul 23, 2013 12:40 PM
Pioglitazone controls a 700 crore/- market in India, that is the only reason i see why the ban is being lifted. The amount of Pharmacovigilance activity taking place in India is negligible and if in such a state there have been 8 reports found to be associated with bladder cancer due to a single drug in a single city, the implications have to be high. Yet the DTAB is planning to lift the ban. I do not understand the logic behind lifting the ban over this drug
biju Jul 22, 2013 5:11 PM
it will affect the sincerity of the GOVT OR DTAB
biju Jul 22, 2013 4:56 PM
this is not a good practice

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