The absence of a regulatory body and proper guidelines for testing labs, coupled with the callous approach of some private labs, are causing immense problems to the ayurveda exporters, especially after the government made testing of heavy metals mandatory for exporting.
The story of Delhi-based Surya Herbal Ltd and a couple of other small-scale firms are some cases in point. These firms had to suffer huge losses due to the faulty testing of samples by the multinational testing company SGS Lab, whose logo incidentally says 'when you need to be sure''. Apart from the financial losses, the companies were robbed of further export possibilities due to the arrogance of the company in redressing the grievances.
"We depended on SGS as our customers relied on its reputation. But their faulty reporting of heavy metals caused us a loss of Rs 80 lakh in 2003-04 and later in 2006-07. And our repeated efforts to get a redressal or an explanation from the SGS also found little response for long. We are at a loss, not knowing where to go now as there is no mechanism like tribunal or regulatory authority to be resorted to," Surya Herbal managing director Inder Setia told Pharmabiz.
As many as 14 batches of one product for which SGS gave certificate as 'not detected' failed heavy metal test in Ukraine in 2003-04 when they were exported. Later when the same samples were sent to another lab in India, tests confirmed the presence of heavy metals as reported by the Ukraine authorities. Again similar incidents happened with their consignment to Norway where the authorities found heavy metals in the product beyond the permissible limit though SGS had tested them as 'not detected', he explained.
After three years of constant efforts through letters and meetings with the representatives and the managing director of SGS India, Surya Herbal got the terse reply - they could not be held responsible as the samples were not drawn by them.
The multinational lab chain meted out the same treatment to the media too, claiming that they could not share any information. When contacted by Pharmabiz, SGS compliance officer and national quality manager S Suresh claimed that the Surya case was prima facie not acceptable, but assured to explain the matter on a written request as they believed in transparency.
"SGS is not in the habit of disclosing information about our customers and we do trust in our values of ethics and confidentiality as SGS is the world's leading inspection, testing and certification company," Suresh said in his short e-mail reply to Pharmabiz.
"Small SSI units cannot fight the might of such multinationals. And the system of addressing a grievance by a customer is also tiring. We are planning to take up the issue with industry bodies and Pharmexcil," Setia said.
Crown Pharma, another exporter of ayurveda products, also faced similar problem when their consignment failed the heavy metal tests in East Europe in 2003-04, though they also had an ND certificate from SGS. Crown Pharma managing director Nitin Kapur said that he escaped the loss as the heavy metals were under permissible limit. His company also received different results about the presence of heavy metals different times from SGS and now they were sending samples to other labs.
One more small scale firm also came in for similar kind of crisis, it is learnt. Industry experts felt that it could be the difference in methodology that caused such variation in tests. SGS, a reputed multinational, may be lacking expertise in herbal formulation tests and must be changing their methodologies, according to experts.
However, in the absence of a regulatory body or an agency to monitor such complaints, the small scale units are left with just one option of going to legal redressal which is time consuming. There are also no guidelines to monitor the private labs in such cases and no common rules exist with regard to fee structure too.
Keeping in view the study report published in the Journal of the American Medical Association (JAMA) and subsequent actions taken by US and Canada regarding the allegedly high contents of heavy metals (lead, mercury and arsenic) present in some ayurveda products exported to those countries, Ministry of Health had made the heavy metals tests mandatory for herbal, ayurvedic, siddha and unani medicines from January 1, 2006.