The Ayurveda, Siddha and Unani (ASU) manufacturers in the country have urged the union health ministry to make necessary amendments in the 'Cluster Scheme', announced by the department of Ayush, to make the scheme feasible and attractive. The manufacturers plead that the scheme in its present form is well nigh impossible to implement as there are several hurdles.
The manufacturers have demanded that the criterion of 15 promoter-manufacturers who are Schedule T certified to form the cluster should be done away with and the manufacturers having manufacturing licences valid for over 3 years should be allowed to form the cluster. This waiver will allow manufacturers with valid manufacturing license but without Schedule T GMP certificate to avail of this cluster scheme.
The manufacturers also urged the government for permission for part processing and packing at the common cluster facilities on the plea that with the inception of the cluster common facilities, manufacturers may rely on sophisticated packaging as well as part processing facilities located in the cluster complex. They asked the Ayush department to direct the state licensing authorities to approve products of manufacturers who do not posses the departments within their own manufacturing premises but rely on the cluster common facilities for such packaging/processing. This direction to state licensing authorities is essential to provide for a change from conventional practice.
Another major demand is that the deemed manufacturers who rely upon loan license system and have such licenses valid for over 3 years may also be considered for the promoter group for the cluster project. This would broaden the scope of eligible manufacturers who can participate in the cluster scheme and allow loan license manufactures to take first step by investing in cluster as part of their backward integration programme.
The manufacturers also urged the ministry to consider other stakeholders like cultivators, collectors, medicinal plant traders, ayurvedic colleges, public testing laboratories, extract manufacturers, ASU practitioners and others to become eligible promoters of the cluster project and their membership may be considered at par with Schedule T GMP manufacturers as it may actually bring in a lot of benefit of working together for overall benefit.
Another demand is in regard to the NABL accreditation which is one of the criteria for forming the cluster. NABL accreditation is very sophisticated and only a few laboratories have this coveted recognition. The standard is also higher than one fundamentally required by the ASU sector. Hence the laboratories set up in the Ayush cluster scheme need not be accredited by NABL, but such laboratories should meet the criteria as prescribed under Part XVI (A) of the Drugs and Cosmetics Rules, 1945, the manufacturers said.
Meanwhile, the Ayurveda Drug Manufacturers Association (ADMA) has taken up the issue. ADMA general secretary Ranjit Puranik said that the association will soon approach the ministry in this regard.
In order to give a fillip to the ASU industry, the Ayush department has proposed to set up clusters in different parts of the country. Under the project three clusters will be set up in Maharashtra one each in Nasik, Pune and Kokan.
The clusters will be useful to the industry, especially the small and medium manufacturers who cannot afford to establish advanced facilities on their own, as there will be all types of common facilities in the clusters. With the government shifting its focus on quality, the clusters will go a long way in upgrading the quality of these products.