Drug Cos Hit By Hike In Irradiation Charges To Sterile Medical Products With Shutdown Of ISOMED

Mumbai, 8 Oct 2018: Drug manufacturers have written to the Board of Radiation Isotope and Technology (BRIT) to control the sudden hike in charges by private gamma irradiation processing plants to sterile medical products with abrupt shutdown of government run radiation processing ISOMED facility.

The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of products. Processing with gamma irradiation yields quick turnaround time, easily penetrating packaging and product and is ideal for many types of materials.

BRIT, which is a unit of the Department of Atomic Energy (DAE) headquartered in Navi Mumbai, used to offer irradiation processing to its customers through its Mumbai based ISOMED facility located in Chembur for the past 44 years. As per a recent notification, BRIT stated that it had to resort to prolonged shutdown of the facility to address ageing related degradation particularly with respect to safety critical systems of the facility. 

The notification further stated that round the clock operation of the facility will be kept in abeyance with effect from October 1, 2018 for at least 24 months. It may be noted that resumption of the operation of the facility would depend upon the restoration of the health of degraded safety systems subject to regulatory approval.

All the stakeholders have been advised to make suitable arrangements at their end for terminal sterilisation of their products. 

All Food and Drug License Holders Foundation (AFDLH) president Abhay Pandey said, “We have received many complaints in the past two months for arbitrarily fixing the price at Rs. 1,500 per unit/carton by private irradiation processing plants which earlier used to be around Rs. 300 when processed at BRIT’s ISOMED facility.

There are around 14 such private processing plants in the country with 5 in Maharashtra and BRIT is a regulatory body for the private irradiation processing plants in the country. 

Gamma irradiation is a process that sterilises medical products of harmful micro organisms besides being a mandatory process to be complied for export purposes which all the products have to undergo to meet international regulatory requirements.

Compounding the problem further AFDLH pinpoints that majority of product manufacturers are small scale units and therefore it is not feasible for them to install their own in-house gamma irradiation processing unit which alone costs Rs. 1 crore. The body has contested that because of this sudden hike in processing charges of gamma irradiation it is creating problems to sustain small scale units 

Due to such sudden hike in processing charges, this will also lead to hike in price of products due to demand supply gap in the market besides hampering the export market. 

It has been given to understand that private irradiation processing plants have connived with each other to set in monopolistic trade practices through mutually agreed charges of upto Rs. 1500 per unit or box. Therefore, it is high time to resolve the issue for betterment of small scale manufacturers. 

As of today, BRIT besides offering isotope applications in industry and radio-analytical services also supplies a vast array of high quality radioisotope products for medical and industrial use that include therapeutic and diagnostic radio-pharmaceuticals, labeled compounds and nucleotides, radio-chemicals, sealed radiation sources and radiation technology equipment including gamma chambers, blood irradiators and radiography exposure devices. Pharmabiz