The Food and Drug Administration, Maharashtra may take action against Wockhardt Ltd. for discrepancy in description on the label of its human recombinant insulin mixture Wosulin 50:50, within a week. With the results from drug testing laboratories in possession of FDA, the punishment for the offence could be suspension or cancellation of the product license, according to FDA sources.

According to test reports, the insulin product, which should be in suspension form, was found to be a clear solution. The FDA informed that the product violates a single parameter on description, while all the other parameters claimed on the label are perfect as per the result. "We are considering the level of action to be taken, as the Administration is handling a serious issue. The action will be decided within a week, by consulting the higher officials," an official told Pharmabiz.

Earlier, by the end of November 2006, the Maharashtra FDA had asked the company to suspend manufacturing and sales of the product for investigation after receiving complaints from consumers. Though the samples were sent to the Central Research Institute, Kasauli in Himachal Pradesh, the Institute reverted the samples stating lack of facilities to conduct the certain tests. The Administration has sought explanation from the company on the issue and had a meeting with the company officials prior to taking action, added sources.

However, the FDA refused to reveal whether the action would be on the particular mixture of Wosulin or on the whole product. The Administration had conducted tests of a number of samples drawn from various batches and out of that six samples were tested at Aurangabad, where the company's manufacturing facility is located, they said.

Meanwhile, the company officials refused to respond or comment on the issue, including on the new developments. "As we have already informed, there were some issues with the product, which we are currently investigating on our own. However, the product has been withdrawn from the market all over India instantly after receiving the complaints from the market and the notice from the FDA," informed the company spokesperson.

According to experts on diabetes treatment, there are chances that the regular insulin would have filled in the mixture bottle in some batches, which were seized by the officials. The issue may also occur if there is some issue with the mixing or manufacturing of the mixture, in which a particular quantity of regular clear solution is added with the suspension form. The use of clear solution instead of longer acting mixtures or suspension solutions would be harmful for the patient as the former occupies double the strength than the suspension drug, added expert specialists from the field.

Wockhardt, by introducing the Wosulin by August 2003, is claimed to be the first in Asia and fourth in the world to develop, manufacture and market the product. The product has been developed with an effort of its state based entity for 10-12 years while major companies, from United States and Europe were controlling the global market for human recombinant insulin valued at over $3 billion, according to sources. The company also have a mixture product, Wosulin 30:70, in the market. The FDA's report on the product comes when the company is planning to move towards new insulin analogues, to be developed, manufactured and marketed indigenously, it is learnt.