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Maharashtra FDA serves notices to 3 gamma irradiation units in Vasai, Ambernath & Vashi for running without cold storage facilities
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Shardul Nautiyal, Mumbai
January 18 , 2019
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The Maharashtra Food and Drug Administration (FDA) has served show cause
notices to three Gamma irradiation facilities namely Agro Search in
Vasai, AV Processor in Ambernath and Board of Radiation Isotope and
Technology (BRIT) in Vashi which were running without cold storage
facilities in gross violation of Drugs and Cosmetics (D&C) Act.
These
facilities were sterilising products at 35 degree centigrade
temperature when the products need to be sterilised at controlled
temperature of below - 25 degree centigrade thus affecting the efficacy
of the medicines or products.
The show cause notices were served
based on the inspections done over the past one month. There are around
14 such private processing plants in the country with 5 in Maharashtra
and BRIT is the regulatory body for the private irradiation processing
plants in the country.
Following manufacture, some medicinal
products need to be stored and shipped at lower than ambient
temperatures to assure their quality and efficacy. These are often
referred to as “cold chain products”.
Cold chain items, such as
vaccines, insulin, biotech products etc can be classified as
particularly high risk because they are at risk from freezing as well as
elevated temperatures.
Wholesalers, retailers and gamma
irradiation plants which have Form 28 as per norms are expected to store
and distribute them in strict accordance with the product labeling
requirements.
Gamma irradiation is a process that sterilises
medical products of harmful micro organisms besides being a mandatory
process to be complied with for export purposes which all the products
have to undergo to meet international regulatory requirements.
With
abrupt shutdown of government run radiation processing ISOMED facility,
drug manufacturers had to rely on private gamma irradiation processing
plants to sterilize their medical products. However, many complaints
came up against private irradiation processing plants for arbitrarily
fixing the price at Rs. 1,500 per unit/carton which earlier used to be around Rs. 300 when processed at BRIT’s ISOMED facility.
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. 1,500 per unit or box, according to All Food and Drug License Holders Foundation (AFDLH).
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.
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