Norms should've been followed: Mahesh Zagde

Interview with FDA commissioner, Maharashtra

Maharashtra's Food & Drugs Administration (FDA) commissioner Mahesh Zagde spoke to Sanjay Jog on the cancellation of J&J's licence for making cosmetics at its Mulund plant. Excerpts:

What prompted FDA to initiate action against J&J?

J&J had licence to manufacture baby powder at Mulund plant. The company was following the process of steam sterilization. During the internal investigations in 2007, the company found that some of the batches had very high micro flora and therefore the company decided to sterilize those batches again.

However, the baby powder was packed in the containers. The company decided to sterilize by Ethylene Oxide for which the standard operating process was not submitted to FDA. In my view, J&J should have strictly followed stipulated norms.

Was the company's action unilateral without keeping FDA in the loop?

J&J did not carry out sterilization process using Ethylene Oxide at its Mulund plant but got it done from some other company which did not have licence to do this kind of process. The company thereafter released sterilized powder packs in the market.

The company did not have data to check whether traces of Ethylene Oxide did not remain in the powder as it is highly carcinogenic. The company released about 1,60,000 small packs in the market and in effect exposed equal number of babies to carcinogenic substance. This is highly objectionable irresponsible and illegal.

Was there delay in taking action against company by FDA?

FDA as a regulator would have failed had it not taken action against the company and failed in its duty. FDA is supposed to protect the lives of people and health of the people. The batches were manufactured in 2007 and FDA acted upon on a complaint but investigations dragged on and on. Subsequently, FDA ordered the re- investigation and arrived at this conclusion.

FDA has started inspection of each and every manufacturing unit every year as mandated in the law which was not there earlier. The inspections will be scrutinized at the FDA HQ whether they were really perfunctory or serious.

What the lessons consumers should learn from this episode?

Consumers should not go just blindly by brand or by mere advertisements. But the consumers should carefully look at contents. If they found something wrong they should immediately approach FDA.