The drug manufacturing units in the herbal and siddha sector see a blank future as the deadline for GMP compliance under Schedule T of Drugs and Cosmetics Act nears. The government''s time extension for the existing units in the sectors to conform to the requirements is ending by December 2002.

Companies in Tamil Nadu manufacturing products of Indian Systems of Medicine (ISM) may not be able to comply with the GMP norms within the set deadline of January 2003. According to industry sources, the main reason for the same is the little attention is being given to such companies by the state government compared to other industrial sectors.

"What we currently see is that the whole point of focus is being showered upon companies manufacturing products under the allopathic system and hardly any attention is being given to the plight of companies manufacturing ISM products," feels an industry source.

The companies manufacturing siddha products in the state are sore with the Tamil Nadu government for its Nelson Eye. What has further worsened the situation is that while on one hand the state government is speaking of standardizing the siddha system it has hardly been of any help to companies manufacturing siddha products either by way of policies promoting siddha system that could help them in the long run nor extending any financial assistance to help them comply with the GMP norms that takes effect following the amendment to Schedule M. What has come as a solace to them is the two-year extension granted to comply with the GMP norms.

Says a spokesperson of the Tamil Nadu Ayurveda Small Scale Manufacturers Association (TNASSMA), "Ayurveda and siddha system has hardly been of focus except for big ideas to promote them. The state has a good number of manufacturers of ayurveda and siddha products but there have hardly been helped. The concept of GMP norms have never been discussed such that these manufacturers hardly have any knowledge of GMP. Now they ask them to be GMP compliant. How do we go about." The spokesperson squarely blames the Tamil Nadu government for the pitiable condition of these manufacturers.

Industry experts feel that while there are no Greenfield projects coming up under the ISM aspect, the task of ensuring existing facilities to comply with GMP norms would be horrendous. "There is no aspect of GMP taken into consideration when these facilities came up. Now with new norms stipulated there is unlikely that there would be GMP compliant facility in this segment what with no policies favouring them and the deep financial crisis they are in," an industry expert feels.

Sources in the Department of Indian Systems of Medicine and Homeopathy (DISM&H) feel that the government should take concerted efforts in grouping these companies to face the challenge. "At present the Department has imparted knowledge on the new norms stipulated but the fact is that isn''t enough, we need to help these companies in a big way, specially extending financial assistance. Or else these companies complying with GMP norms is suspect," said the source.

What has grieved the companies is the delay in appointing an expert committee to look into the aspect of manufacturing space as stipulated in the new amendment to Schedule M as part of the GMP compliance norms. This expert committee was to reconsider the mandatory manufacturing space and bring about a reduction so as to help the existing manufacturers.

The Food and Drug Authority of ten states had called upon a reconsideration of the mandatory manufacturing space. Assurances of setting up an expert committee still holds good but the expert committee is still to be constituted. The suggestions brought forward by the FDCA officials before the Department of ISM points out that the 1200 sq. ft area required in the drug manufacturing unit as per the GMP norms will be a major problem for most of the existing small scale units. They feel that it is not necessary to have separate sections for storage, workers and packing and labeling sections, where there is no chance for cross contamination, can be integrated into one. If a single room can be used for these requirements, the space can be saved, the officials suggested in their recommendation