Drug regulator finds Alkem Labs drug substandard, again

It's the third alert to be issued in the past one year for the anti-diabetic drug; but no recall this time

The Central Drugs Standard Control Organisation (CDSCO) has found Alkem Labs’ anti-diabetic drug Glimekem to be of substandard quality.

This is the third time in the past one year that the CDSCO has issued an alert for this drug. The regulator had issued alerts in June and July of 2015. The company was then asked by the regulator to recall the specific batches from the market.

This time, however, the company has not been asked to recall the batches. “We have already revised our formulation and started marketing batches from a new formulation. The four batches (two from last year and two from May 2016) which were in the CDSCO list were from the older formulation,” said a company spokesperson.

The drug, which is used to treat type-2 diabetes, has been failing the dissolution test. It is used to identify rate of dissolution of the medicine in the blood stream in a standardised format.

"We had recalled the batches on the earlier instances. Currently, we have not received any formal instruction to recall the current batch (which was in the May 2016). However, we would recall it once we get a formal instruction," clarified the spokesperson.

According to company's earlier statement, this drug constitutes annual sales of a few lakh rupees only, out of its total drug sales of Rs 3,500 crore in India.

The company said there was no issue with the new formulation and the issues were specifically related to old formulation. The recent tests were done in the central drug regulator's Kolkata laboratory.

These two batches were manufactured in February and March last year at the company's plant in Solan, Himachal Pradesh.