Chennai DTL will soon be notified by CDSCO to test medical devices

Chennai, January 4, 2023:

The drug testing laboratory (DTL) under the department of drugs control in Tamil Nadu is likely to be certified soon by the government of India to carry out test and evaluation for medical devices (MDTL).

However, the DTL is currently not eligible for notification as MDTL because it has not yet been accredited with NABL certification. According to sources from the Chennai DTL, only NABL accredited laboratories are eligible to be notified as facilities to test medical devices.
 
Sources form the DTL informed Pharmabiz that they are waiting for the inspection of assessors from the National Accreditation Board for Testing and Calibration Laboratories next week. The lab had applied for NABL certification in the month of December last year.
 
Talking to Pharmabiz, the chief analyst Ra. Siva said although the Central Drug Standard Control Organisation (CDSCO) is taking steps to notify government DTLs in each state as approved MDTLs, the problem of NABL accreditation becomes a hurdle for most of the state DTLs. However, government laboratories in certain states have already been approved by the CDSCO. Since the number of approved government labs (MDTL) is less, the government has notified six NABL accredited private labs in the country for testing and evaluating medical devices.
 
Siva said the Chennai DTL has all the technology and machinery to test medical devices and its capacity to test is 10,000 samples per year. The second DTL established in Madurai will be ready for functioning from next month. Latest machineries bought by the TN Medical Services Corporation (TNMSCL) are being installed now. The work will be completed within one week. He said the assessors from NABL coming to Chennai to inspect the DTL will be taken to Madurai to see the new lab also.
 
Considering the slow process of the CDSCO in conducting inspections and notifying government DTLs, the Drug Control Officers India Welfare Association (DCO India) has wanted the union health ministry to direct CDSCO to speed up the process. DCO India’s president Koteeswara Rao has alleged that poor manpower of the CDSCO is the problem for the delay in conducting inspections as there are a lot of NABL accredited labs in several states. He said the central drug control administration is weak and lackadaisical in giving training to state regulators in medical services rules, but they have trained their staff soon after the rules came in force. Pharmabiz