The Kerala Health Department's recent decision to mandate quality assurance certification from the Central Institute and Research Laboratory (CIRL), Kassouli for participating in the annual tender process for the supply of surgical sutures have caused acute shortage of surgical sutures in government hospitals, following the delay in feedback from the institute and completion of the tender process, it is learnt.

According to informed sources, the Central Purchase Committee (CPC) of the health department had sent the samples produced by the firms in the tender process for 2004-'05 to the CIRL, Kassauli, following the government decision during early period of April, this year. However, the institute has not been able to process the samples and give the feedback so far, mainly because of the lack of facilities to test synthetic sutures, which constitute majority of the samples, according to sources. Lack of follow up and procedural delays on the part of the health department have further compounded the problem.

The delay in new supplies to the government hospitals has caused acute shortage of surgical sutures, and the respective hospital authorities are now forced to purchase sutures locally from private players as a contingency measure. In some of the major government hospitals, relatives of the patients are forced to purchase sutures from outside for conducting some emergency surgical procedures. The government hospitals in Kerala require about Rs 5 crore worth various surgical sutures annually.

As per the Drugs and Cosmetics Act, the CIRL is the authorized agency to certify the quality of surgical sutures. In the earlier CPC procurement system, a committee appointed by the doctors was the authority to certify the samples submitted for scrutiny during the tender process. There were complaints that many of the patients had to be operated again as the sutures were of low quality and stitches broke away before the normal period of healing. As per the practice, the sutures have to last from one week to one month depending on the types of surgeries, and the stitches should worn out after the prescribed period.

There were allegations that the monitoring committee of the doctors lack technical knowledge to judge the quality of medical sutures. There were reports that huge quantities of surgical sutures were lying idle in the various stores of the medical colleges, district and taluk level government hospitals in the state as they were found to be of poor quality.

Various level enquiries, including vigilance probe, are going on into the matter. A few cases are also pending before the Kerala High Court related to the irregularities in purchase of surgical sutures and medicines.

Following the developments, the health department brought in a rule with immediate effect during April this year to mandate quality assurance certification from the Central Institute and Research Laboratory (CIRL), Kassouli for participating in the annual tender process, also applicable for the current year purchases.