While the Central Government has directed the state drug controllers to cancel the manufacturing licenses of non Schedule T compliant ASU drug units, it is impractical to strictly implement the rule with immediate effect due to lack of adequate manpower with various state drug departments, according to informed regulatory sources.

In pursuance of Section 33P of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Department of AYUSH had directed all the state ASU drug licensing authorities during the second week of October to take action against the defaulting ASU drug manufacturers for revocation of their licenses under Rules 157, 158 and 159 of the Drugs & Cosmetics Rules, 1945 for failure to comply with the Good Manufacturing Practices notified under Schedule 'T' of the Drugs & Cosmetics Rules, 1945.

Though the time frame given to implement GMP standards according to Schedule T had ended during 31st December 2003, none of the state licensing authorities was able to take action against non-compliant units effectively, except for Gujarat and Karnataka. Sources point out most of the state level drug control administrations have only one or two officials, that also for name sake, in charge of regulatory affairs of the ASU drug sector and this is a major obstacle in implementing the rule strictly. Most of the states are yet to appoint trained staff to exclusively regulate the ASU segment.

The Karnataka authorities had cancelled the manufacturing license of 110 units, out of a total of 250 units for failing to comply with Schedule T during early 2004. Karnataka has only four drug inspectors to regulate ASU drug manufacturing and sale activities in that state.

Out of the 558 licensed ISM drug manufacturing units in Gujarat, 133 were Schedule T compliant and another 17 were licensed as per the requirements by the time of deadline during 2003 end. So far, notices were sent to 408 units and subsequently 307 manufacturing units were forced to close down in the last two years, according to Dr. S P Adeshera, Gujarat FDCA Commissioner. This is despite the fact that Gujarat FDCA functions with a shortage of more than 50 per cent staff as against the sanctioned posts of drug inspectors and other senior officials.

Kerala, the largest Ayurvedic drug manufacturing state in India with over 1000 licensed Ayurvedic units, is yet to implement the rules strictly. So far only 300 to 400 units in the state have either got the GMP certification or 'are still in the process of implementing Schedule T norms'. Only three drug inspectors and an assistant drugs controller regulate the 1000 odd ayurvedic units in the state and lack of manpower is slowing down the process of inspection, according to officials.

Same is the case with Tamil Nadu, the home of Siddha medicine. The state has over 1000 to 1500 Siddha drug manufacturers. Out of them, only a small percentage of units have set up the requisite manufacturing standards. Lack of adequate manpower is cited as one among the reasons for not strictly implementing the rules.