Department of Ayush has now permitted use of Gamma Irradiation (GI) to control the microbial quality in preparation of ayurveda, sidha and unani drugs.
The much-awaited order spells a big relief to the ISM manufacturers who have been representing to the Department of Ayush to permit use of GI. The department thus undertook an exhaustive study on chemo-profiling and conducted a bio-efficacy evaluation of herbal and plant-based formulations at the Regional Research Lab in Jammu. The products were pre-treated by GI at the Bhabha Atomic Research Centre (BARC), Mumbai.
The results of the study were evaluated by the Food and Technology Division of BARC, along with experts at the Ayurvedic Pharmacopoeia Committee (APC). A dose of 5-10 KGy is recommended for the prevention of microbial growth of herbal and plant based drugs, considered and referred as "Low dose GI".
The results of the scientific study proved that GI not only was beneficial to thwart the microbial growth but also can increase shelf-life of the products in a safe manner. In fact, a similar study was conducted a few years ago on spices, vegetables and fruits. The efficacy of GI treatment was proved and recommended in the horticulture sector.
According to the department of Ayush, the required dose of GI could be revised in consultation with BARC. Manufacturers of Ayush drugs could also display use of GI on the labels of the container as per the requirement of the domestic and international marketing rules.
Further, the order also called for the support from the Department of Atomic Energy and BARC to facilitate GI for herbal and plant based drugs and extends the applicable concessions. "It is hoped that the companies offering GI would extend these concessions to the Ayush industry that cannot afford high cost of treatment for microbial quality improvement," informed Ayurveda Drug Manufacturers Association.
The order comes in as a big relief according to the herbal industry sources. The sector constantly faced rejection of consignments because of high microbial levels. Several methods including sterilizing and autoclaving were adopted to reduce the microbial content in the drugs but resulted in problems when it is used for herbal based products. In fact these procedures ended up in drastically reducing the flavour, colour and even spoil the product, in some cases.
As a last resort, fumigation with a chemical compound ethylene oxide (EtO) was adopted some years. But the method was banned globally because high levels of residual EtO found in the products, proved to be carcinogenic. "Now the GI has scientifically proved to reduce the number of product rejections. It is affordable and has been already in vogue for fruits, vegetables and spices. India has around 15 approved centres for GI including Bangalore at Rashmi Radiation Centre in Kidwai Memorial Institute of Oncology, Manipal Hospital, and Microtrol which perform GI for non medical purposes," informed Dr DBA Narayana, member, technical committee ADMA.
"With BARC having standardized the GI technology, the government is encouraging entrepreneurs to take on the service and bank loans are offered to companies to commence operations and welcomed the move and wished that ASU industry adopts and improves the quality of medicines", informed Dr Narayana.