The Maharashtra Food & Drug Administration (FDA), as a part of its Schedule M implementation drive in the state, has cancelled manufacturing licenses of 274 pharmaceutical manufacturing units out of the total 1024 units in the state till March 29, 2010. The FDA began the drive in July 2005.
A total of 746 units have complied with the revised Schedule M norms in the state. The FDA has cancelled manufacturing licenses of 274 units under this drive, according to the latest data available with the FDA.
In Mumbai, out of the total of 151 drug manufacturing units, 79 units have complied with the revised Schedule M. A total of 71 units have lost their manufacturing license as they failed to comply with the revised norms and one unit has been listed under non-compliance.
The situation is not much different in Pune where out of a total of 162 drug manufacturing units, 120 have complied. The FDA has cancelled manufacturing licenses of 40 units in this division. Two units are not complying with Schedule M.
Among all the divisions in the state, the Konkan division stands out alone in Schedule M compliance. Out of the total 746 Schedule M complied units in the state, 366 units are in the Konkan division. Out of 486 units in the division, 366 units have complied the norms, while the FDA cancelled 120 units in the division.
In Aurangabad division, which has a total number of 72 manufacturing units, 55 units have complied with the revised manufacturing norms while the FDA has cancelled 17 units in this division. Aurangabad's Ethicas Pharma is facing court case for non-compliance under Schedule M.
In Nasik division, out of the total of 99 units, 77 have complied the norms and FDA has cancelled the license of 17 units in this division. In Nagpur division, out of the 35 units, 32 have complied the norms while the FDA has cancelled the license of three units. In Amravati, the FDA has cancelled two units out of the total 19 units. The rest 17 units have upgraded their facilities as per the revised Schedule M norms.