Two medicines, one of them a top-selling drug to check blood sugar, which were banned by the Central government a month ago, are all set to return to the market within days as the Union Health Ministry has decided to lift the ban.
The ban on the sale of pioglitazone — an anti-diabetis medicine with a Rs 830-crore market in India — and painkiller analgin is expected to be revoked after an expert group suggested lifting the prohibition, reliable sources told Deccan Herald. Both were banned by the Union Health Ministry on June 18.
In the last one month, there has been no new study to establish the two drugs’ safety. But the Drug Technical Advisory Board in the health ministry has suggested revocation of the ban after a few individual doctors approached the ministry and the media argued against the ban.
The prohibition order on pioglitazone was issued after a section of doctors informed the drug regulator about long-term risks associated with the medicine. Continuous use of the medicine can cause urinary bladder cancer.
Analgin was under the scanner for a long time, but the Drugs Controller General of India (DCGI) initiated action only after the Parliamentary Standing Committee on Health came down on the DCGI, first in May 2012 and subsequently in April 2013.
Sold under the brand name Baralgan-M and Novalgin, the medicine carried the risk of severe fall in white-blood-cell count — a potentially fatal condition. Analgin is banned in many countries, ranging from the US and France to Nepal and Nigeria.
It also does not figure in the national list of essential medicine. But the medicine continued to be sold as an over-the-counter drug for years.
After receiving flak from the House panel, the health ministry banned four medicines in the last two months, the other two being denaxit and dextropropoxyphene, which was being sold under the brand name of Proxyvon. The pharmaceutical industry was hit hardest by the pioglitazone ban.
“Within days of gazette notifications, the industry was up in arms against the ban. This was but expected. After all, a total revenue loss of over Rs 900 crore for two drugs is not a small matter,” says an editorial in the upcoming issue of a pharmaceutical industry journal called Monthly Index of Medical Specialities (MIMS).
In India, pioglitazone products have an annual sale of Rs 830 crore. The lion's share is cornered by the fixed-dose combination (FDC) of pioglitazone with metformin and glimepiride (Rs 540 crore).