Almost 73 per cent of the pharmaceutical units in Maharashtra have complied with revised Schedule M norms, even as 25 per cent of the units lost their licenses for non compliance with the standards till May 2008, according to the records with the Maharashtra state Food and Drugs Administration (FDA).
The state FDA has issued license for 109 more units in the state in a period between April 2007 and May 2008. With this, the state currently has 731 Schedule M complied units out of total 1007 units, according to FDA officials. The administration has cancelled license of 86 units in a period from April 2007 to May 2008, making a total 251 units in the state losing their license for non compliance of the good manufacturing practices (GMP) under the revised Schedule M.
Further, 25 units are under technological upgradation process, for which the manufacturing license was cancelled for the time being. However, many of these companies have partially complied with the standards for which the manufacturing approval has been allowed, according to FDA officials.
"There are only a few units which have not complied with the manufacturing standards and the manufacturers have informed us that the process is on progress. Some of these companies have complied with the norms in some of their divisions and we are considering it as partially complied units. The units can apply for fresh license once the whole upgradation process is completed. We have not fixed any time limit for this," said a senior FDA official. Many of the companies which are under upgradation are manufacturing products like petroleum jelly, which plays less important role in pharmaceutical products.
Some of the districts which were rich with presence of pharmaceutical companies had faced a heavy loss in unit strength after the implementation of the latest GMP standards, finds the official records. For instance, the total number of units in Mumbai region has decreased from 150 to 80, as the rest of the 70 units was closed down due to non compliance of quality standards.
Meanwhile, the plants which have already certified as GMP complied are also going through the annual inspection from the regulatory office, as the revised Schedule M insists at least one inspection from the state drug regulatory office on each manufacturing plants in a year. The official opined that the companies can maintain the standards as per the requirement once they qualified GMP norms.
However, if any unit has found to be lacking quality norms in the annual inspection could have to face suspension or cancellation of license immediately, added the source. As Pharmabiz reported, last year the FDA announced that it has cancelled manufacturing license of 165 pharmaceutical manufacturing units out of the total 1005 units in the state till April 2007, even as 622 units were certified for complying with revised Schedule M.