CAG Raps FDA Over Poor Functioning Of Drug Control Labs

Mumbai, 5 April 2018: “Food and Drug Administration (FDA) working under the Medical Education and Drugs Department (MEDD) in Maharashtra have failed in ensuring the quality of drugs supplied due to inadequate testing and failure to follow-up effectively. This can have serious consequences for the health and welfare of the public,” slams Comptroller and Auditor General of India (CAG) in its recent report.

CAG has expressed a serious concern over the functioning of Drug Control Laboratories (DCL) in the State.

After auditing the records of all three DCLs at Mumbai, Aurangabad and Nagpur, CAG has mentioned that the DCLs in Aurangabad and Nagpur did not have facilities to conduct microbiological test on drugs and cosmetics.

As a result, all the samples were being sent to DCL, Mumbai, where they were unable to cope with the volume of work. Opportunity to strengthen and upgrade the DCLs by purchasing different modern equipment was lost despite availability of funds due to non-receipt of approvals from MEDD/Finance Department to the purchase proposals of the FDA, a report stated.

Nagpur DCL is non-functional

The Drug Control Laboratory (DCL) started functioning in Nagpur city, since July 2016 has tested only 88 drug samples during the financial year 2016-17. The DCL has received 140 drug samples from the drug inspectors but 52 samples were pending without testing. This means within 12 months, DCL Nagpur has tested only 88 samples. Thus, it tasted about 7 drug samples a month.

No facility of Microbial testing at DCLs in Aurangabad, Nagpur

The DCLs in Aurangabad and Nagpur did not have facilities to conduct microbiological test on drugs and cosmetics requiring such tests. DCL, Mumbai alone has the facility.

DCL Nagpur is without head

“Despite starting functioning since July 2016, no posts have been sanctioned by the Government at DCL Nagpur. The work was done by officials on deputation from DCL Aurangabad,” a report said.

Juniors handling affairs at all DCLs

Availability of adequate technical and non-technical manpower, instruments and chemicals is essential for carrying out complete and timely analysis of the drug samples. All DCLs -- Mumbai, Aurangabad and Nagpur -- were working without Assistant Directors till March 2017. 

AD is the head of the laboratory responsible for overall function. All five posts of senior scientific officers sanctioned at DCLs Aurangabad and Mumbai were vacant till March 2017. There were 35 sanctioned posts of Scientific Officers at DCLs in Mumbai and Aurangabad. Out of these posts, only 19 posts are filled while 16 are vacant. There are 32 sanctioned posts of analytical chemists at Mumbai and Aurangabad DCLs out of these eight posts were vacant.

Stating that the shortage in the key posts of Senior Scientific Officers and Scientific Officers was alarming and was one of the reasons for the delay in testing of drugs, CAG also observed that apart from the shortage of manpower, the laboratory staff of Aurangabad and Nagpur DCLs was also not provided training to upgrade their skills. This could affect the ability of the staff to carry out testing properly and on time. 

However, the laboratory staff of DCL, Mumbai was provided training, a report added.

Test reports sans opinion on quality

The Government Analyst to whom a sample of drug or cosmetic has been submitted for test or analysis shall submit to the Inspector a signed report indicating whether the sample is of Standard Quality (SQ) or Not of Standard Quality (NSQ). Audit observed that the test reports issued by DCLs contained three categories -- Standard Quality (SQ), Not of Standard Quality (NSQ) and No Opinion (NOP). 

“Due to non-availability of required infrastructure for testing of these drugs in the laboratory, the complete analysis could not be done and inference could not be drawn for its quality. The fact remained that the issue of test report with no opinion expressed on the quality of drugs tested, was not only in violation of the D&C Act but also handicapped the Licensing Authorities since they cannot take any action on the basis of such test reports,” CAG slammed.

DCLs lack adequate infrastructure, facilities

Audit observed that in none of the DCLs medical devices such as stents, orthopaedic implants, heart valves, were tested/analysed during 2012-17. The exception was a few samples of orthopaedic implants which were tested in DCL, Mumbai in February 2017 for corrosion resistance only.

Deficiencies in sample testing

The DCLs, Aurangabad and Mumbai reported that the content of active ingredients was less than the prescribed limits in 92 (50 per cent) out of 183 NSQ drug test reports test-checked in audit. These samples were, however, not analysed further to ascertain whether the active ingredients were substituted. In absence of further analysis, a drug could be reported as NSQ, instead of spurious drug which as per Section 36-AC of the D&C Act is a cognisable offence.

Question on Standard Quality

Audit also observed that in 193 (23 per cent) out of 835 SQ drug test reports test-checked in audit, as per the laboratory protocol, the samples were declared as of SQ without carrying out various tests such as Microbial content/ limit, related substances and uniformity of weight. This was due to lack of working standards from the manufacturer, technical facilities and sufficient quantity of sample. Thus, complete testing was not ensured by the DCLs before issuing the SQ drug reports.

FDA fails to utilise funds

CAG highlighted, “Budget provision of Rs 53 crore was made for strengthening and upgradation of infrastructure of Drug Control Laboratories (DCL) during 2012-17. The grants received were Rs 40.13 crore, however, FDA was 

not able to spend Rs 30.31crore due to non-receipt of approval of the MEDD/Finance Department to the proposals for purchase of various equipment required for the DCLs. The poor spending in 2016-17 affected the strengthening and upgradation of the Laboratories.The Hitavada