The Union Ministry of Commerce will publish a draft Export Inspection Certification Scheme with proposals, schedules and rules for enhancing quality of Ayurveda, Siddha and Unani drug exports from the country. The Scheme, for which the draft is ready for publication, also proposes Export of Ayurvedic Siddha and Unani (Quality Control, Inspection and Monitoring) Rules, 2007 to specify the type of quality control and inspection.
According to the draft rule, the Export Inspection Agency (EIA), which is currently handling the quality control and inspection of food substances and marine products will issue the health certificates for the ISM drug products based on reports of the unit, in the prescribed format or other required format based on the requirements of the importing country. A Health certificate may be issued on conformity of satisfactory results tested in Export Inspection Council (EIC) and Department of Ayush approved laboratory.
The certificate will mainly have the laboratory tests confirming to the parameters described in the standard together with microbiological tests, the laboratory tests for the additional parameters to be indicated in the health certificate clearly indicating about compliance of the consignment as per the requirement of importing country and the field inspection report (FIR). The EIA, which have a network of laboratories across the country will either utilize their resources for testing the drugs or will equip their laboratories for conducting the drug tests, according to sources close to the development.
The EIA will levy fees at 0.4 per cent of FOB value of consignment for Level 1 certification and 0.2 per cent of FOB value of consignment for Level 2 certification of Ayurveda, Siddha and Unani export products. The necessary instruction on fees for Level 3 certification is to be decided by the council in a later stage.
The standards of products to be exported will be recognized with the national standards of the importing countries or contractual specifications agreed to between the foreign buyer and the exporters provided the same is satisfying the health requirements of the importing countries. An expert committee constituted under the Department of Ayush consisting of eight members including the director of EIC as the group head has set out a schedule of standards with specifications on permissible limits on various contents products.
The draft proposes to recognize the specifications formulated by the committee, with members from industry and Pharmexcil, as the standard specification for Ayurvedic, Siddha and Unani products. The schedule, appended to the draft order, specifies permissible limit of heavy metal content, pesticides residues, Aflatoxins and microbial contamination limits in these products.
The proposal is also to authorize the EIA to prohibit the export of these products in the course of international trade unless they confirm to the standard specifications applicable to it. It also suggests that the a certificate should be issued only for units which produce a certificate of inspection or a certificate that such unit is approved and monitored by any approved and monitored sub offices established under relevant act. The applicant can appeal to the director of I&QC, EIA, within 10 days.
Pharmexcil, which has played a role in furnishing the draft of certification, is planning to conduct a special meeting to discuss the proposed draft to bring in some more changes in the draft from the industry response, before publishing it for public opinion. The meeting, a roadmap for promotion of exports of herbal/ayurvedic products will also discuss about the barriers and constraints in the exports of ASU products and expectations of the industry from central government.
"The idea of setting up a certification procedure for herbal medicine exports was not realized for all these years. Now, we have supported the department to furnish the draft and to make it perfect, we need the response from the industry. The meeting is also designed to bring in a roadmap for herbal products promotion, which is an idea put forward by the department of Ayush," Dr P V Appaji, executive director, Pharmexcil told Pharmabiz.
He added that the draft of the Scheme will be published soon after making the adequate changes through considering the views and opinions of the industry representatives in the meeting.