Usha Sharma – Mumbai
Faced with an unprecedented hue and cry from all quarters – doctors, patients, representatives of various associations from the pharmaceutical industry – to revoke its proposed ban of anti-diabetes drug pioglitazone in the country, there are signs that the Ministry of Health & Family Welfare (MoHFW) is re-considering its decision.
Giving details, Dr G N Singh, Drug Controller General India (DCGI) said, “ In the week after we announced the ban, we received a large number of representations from diabetologists, patients, various association representatives and pharma industry stakeholders. Many media reports too flagged this issue and raised concerns. In response, we called for an experts’ meet on July 11 to which we invited 12 leading medical experts. The meeting was attended by 10 experts and we are currently reviewing the matter they presented. We are concerned about patient safety and we will not compromise on this at any cost.”
The Drugs Technical Advisory Board (DTAB), under the Health Ministry is currently evaluating the experts’ comments of July 11 and will present their recommendation at the July 19 meeting called by and to be chaired by Prof.(Dr) Jagdish Prasad. Director General, Directorate General of Health Services (DGHS), MoHFW. The final decision is likely to be taken on the same day.
More than a week ago MoHFW banned the anti-diabetes drug pioglitazone in India considering adverse drug reactions (ADR) reported in western countries like the US, UK and France, which showed a link to cancer and cardiovascular diseases (CVD). Pioglitazone is the second or third line of treatment for Type II diabetes and is one of the commonly prescribed medicines in India, as also other countries, for the treatment of this condition.
With the ban on the drug, concerned patients reached out to their doctors to seek alternate treatment advice. Industry experts claimed that pioglitazone is the cheapest treatment option available in India.
Reacting to these ongoing developments at the MoHFW, Dr Rajiv Kovil, Consultant Diabetologist, Dr Kovil’s Diabetes Care Centres, Mumbai said, “There are reports that after the expert committee meeting, the ban on pioglitazone will be revoked. The revocation of the ban would have large ramifications. Pioglitazone is a cheap nuclear level drug whose durability of control is the most interesting aspect. Withdrawal would have meant putting patients onto insulin or other expensive drugs. The collective effort by doctors across the country will bring back a rewarding smile to 40 lakh patients who are using the drug today. I am sure all of us who would use the drug in future have to be vigilant and the drug should come with a black box warning to prevent misuse. Over all (this would be) excellent news.”
Dr Awadhesh Kumar Singh, Consultant Endocrinologist, GD Hospital And Diabetes Institute, Kolkatta feels, “The concern over pioglitazone’s link to cancer with data from some western countries is not yet proved fully. Furthermore, diabetes patients are 2-3 times more prone to develop cancer than the normal population. Considering the use of pioglitazone and the cost of the drug (which is cheaper than other diabetes drugs) at current point of time it is inappropriate to ban pioglitazone in a country like India where a majority of patients cannot afford costlier drugs at all.”
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