Karnataka, the state having maximum number of Ayurvedic units next to Kerala, is unable to complete the Schedule T compliance inspection due to lack of adequate drug inspectors.

Karnataka’s Directorate of Indian System of Medicine (ISM) sources said inspection of 167 units in the state for Schedule T compliance or GMP (good manufacturing practises) was progressing slowly for the last 50 days, mainly due to shortage of staff. The directorate has only four inspectors. Each of them will have to inspect and file status report of around 55 units to complete the process. Considering the situation, a proposal has been forwarded to the State Government to urgently recruit more drug inspectors. Sources added there would be hardly 15 units, which are non-compliant to Schedule T.

As per the data available by mid-May 2005, about 120 units out of 167 ayurveda units have received the GMP certification from the State Directorate of Indian System of Medicine& Homeopathy. Most of the remaining units initiated the modernisation process in the last two months.

Almost 90 per cent of the small-scale ISM units have closed down their operations, stated officials from the directorate. Pharmabiz had reported that the directorate cancelled the manufacturing license of 110 units, out of a total of 250 units for failing to comply with Schedule T during early 2004. The licenses were cancelled in two phases. In the first phase, 70 licenses were cancelled and in the second phase, 40 licenses were cancelled.

According to the officials, paucity of funds is the main reason for inability of these SSI units to upgrade their facilities as it require about Rs 50 lakh to Rs 2 crore for complying with the norms.

The Union Government has also increased the license fee from Rs 60 to Rs 1,000 and license renewal has been revised to 3 years from the earlier 2 years. The State Government has fixed the GMP certificate fee at Rs 500, market standing certificate fee at Rs 250 and a no conviction fee for tender applicants at Rs 250.