Karnataka's directorate of Indian Systems of Medicine and Homeopathy has cancelled 110 manufacturing licenses of units here for failing to comply with Schedule T of the Drugs and Cosmetics Act. The deadline for GMP compliance in Ayurveda sector was December 2003 and the licenses were cancelled in two phases.
In a massive inspection drive conducted by the directorate, the licensing authority for Ayurveda drugs in the state, a total of 250 Ayurveda units were inspected and reports were provided on their failure to comply with Schedule T. In the first phase of inspection, licenses of 70 units were cancelled and 40 licenses were cancelled in the second phase. All the units are in the small-scale sector operating out of poorly equipped facilities.
Right now, only 10 units in the state are fully Schedule T complaint. These include The Himalaya Drug Company, Natural Remedies and the manufacturing base of the Mumbai-based Charak Pharmaceuticals in Maddur in Mandya district. The remaining 130 units are only 90 per cent GMP ready and their licenses are scheduled for renewal in December 2004. "The units are struggling to become GMP compliant," Dr. BS Nataraj, director, Directorate of Indian System of Medicine & Homeopathy, told Pharmabiz.com
The directorate is stringent in the approval procedures for granting drug production licenses. It has passed an order that all drug purchases to the government hospitals and dispensaries in the state would be permitted only if the companies are fully GMP compliant. Another rule insisted by the directorate is that drug purchase would be made only from primary manufacturers and not from loan licensees.
The state is ranked second in the country for ayurvedic formulations and bulk drugs after Kerala. It contributes 50 per cent of the total exports in the country. Out of the total of 250 units in the state, 90 per cent are small scale sector and 8 per cent are in the medium-sized that manufacture tablets, oils, arishtams, powders and pills for specific purposes.