The Maharashtra Food and Drug Administration (FDA) is in the process of setting up first of its kind microbiological testing lab at a cost of Rs.4.5 crore at the Mumbai FDA headquarters.
The facility will have a capacity to test 100 samples in a day and detect pathogenic organisms in drugs which will help manufacturers cater to the global regulatory requirements. It will also have the capacity to detect and confirm specified micro organisms as per harmonized pharmacopoeia, trend analysis of microorganisms isolated from the environment and products, bio- burden testing of non-sterile products, antimicrobial efficacy testing, disinfection efficacy testing, preservative efficacy testing and challenge test among others.
French company bioMérieux has also signed an MoU with Gujarat Food and Drug Control Administration (FDCA) to help set up microbiological testing lab which will bring turnaround time for drug testing from 14 days to just 4 hours.
Meanwhile, Maharashtra FDA has recently operationalised a National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited drug testing lab in Nagpur.
Funds to the tune of Rs.17 crore were allocated for the Nagpur project. With this, Maharashtra now boasts of 3 testing labs at Mumbai, Aurangabad and Nagpur. The Centre has sanctioned Rs.138 crore for strengthening drug regulatory system in the state.
The Maharashtra FDA through its routine inspections last year collected 2,760 drug samples and found 205 not-of-standard quality (NSQ) drugs in the state. Out of the samples collected, 317 samples drawn were of cosmetic products.
Complete drug recall of NSQ drugs is the major objective of the inspections conducted across the manufacturing units, retail supply chain and wholesalers.
Union health ministry is also in the process of starting three of the eight mini drug testing labs at Nhava Sheva at Jawaharlal Nehru Port Trust (JNPT) in Navi Mumbai, Ahmedabad Airport and in Mumbai Airport to control exports and imports of spurious drugs.
According to the plan, labs will be equipped with advanced analytical modalities like AAS, GC, HPLC, IR and NIRS among others for effective detection, analysis and reporting on drug quality.
Estimated to cost around Rs.25 crore, the mini-labs will be manned by a team of nine technical personnel led by a senior scientific officer. Health ministry plan includes setting up of mini-drug testing labs at Kolkata, Hyderabad, Bengaluru, Delhi and Chennai.