The Union health ministry in consultation with the Central Drug Standards Control Organization, has prohibited manufacturing and marketing of the three drug fixed doze combinations (FDCs) of rifampicin, isoniazid and pyrazinamide, which does not comply with the standard dosage recommended by DTAB in compliance with WHO guideline.
The notification, which was issued by Ministry of Health, on February 11, stated that the FDCs of rifampicin, isoniazid and pyrazinamide except those provide daily dosage of minimum 450 mg, 300 mg and 1000 mg and maximum of 600 mg, 400 mg and 1500 mg respectively are banned under Section 26A of the Drugs and Cosmetics Act, 1940.
The ban is expected to force the manufacturers of few brands of this anti-tuberculosis combination drug, which are currently in the market. One of the leading brands comes under this ban in the country is AKuriT Z of Lupin Limited. There are around 13 other brands of the said 'improper' dosage range available in the market at present.
The other brands coming under the preview of the ban are;
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Though the notification is effective from March 1 onwards, practically it will take another couple of months to completely recall the products from the market. However, Lupin Limited, who will be affected severely due to the ban, is thinking about various options to overcome the ban. "One of the options the company is planning is that to challenge the Order, with the support of its own trials and tests on the safety of the product. On the other hand the company may also think about reformulating the brand as per the Order in case the challenging attempt fails," said sources from Lupin Limited.