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Lupin, Granules shares slip; street worried USFDA may recall diabetes drug Metformin

Updated : May 28, 2020 06:12 PM IST

The carcinogen found in the drug is the chemical compound NDMA or N-Nitrosodimethylamine

Over the last couple of years, NDMA has gained attention over concerns of its presence in commonly used drugs

Shares of Lupin and Granule drifted lower in a firm market, with some players attributing it to concerns that the US Food and Drug Administrator may shortly recall diabetes drug Metformin in the US. This follows the drug regulator finding elevated levels of carcinogens or cancer-causing substances in some versions of Metformin.

Lupin is one of the prominent manufacturers of Metformin in the US with 7-9 percent of their estimated earnings for this year expected to be from the drug. Other manufacturers include Granules India, where 30 percent of its total sales comprise of Metformin and Metformin related products. Most Metformin related products are in the form of finished dosages, of which 70-75 percent is exported to the US. The company recently received a communication from the US drug regulator stating that their batches of Metformin met acceptable limits. Other companies that manufacture Metformin include Sun Pharma, Aurobindo and Heritage Pharma amongst others.

The carcinogen found in Metformin is the chemical compound NDMA or N-Nitrosodimethylamine. NDMA is feared to be toxic to the liver and capable of causing cancers of the stomach and bladder.

NDMA, the chemical once used to manufacture pesticides and rocket fuel is mainly a by-product of industrial processes and water disinfection. The chemical is found in many processed foods and drinks such as cheese, meats and whiskey.

Over the last couple of years, NDMA has gained attention over concerns of its presence in commonly used drugs such as Valsartan for blood pressure and Ranitidine for stomach acidity.

Consequently, the US drug regulator last month decided to withdraw all over the counter (OTC) and prescription Ranitidine drugs from the market. The move came seven months after the USFDA had first flagged concerns about the drug.

Companies such as GlaxoSmithKline recalled Zantac, its popular version of Ranitidine, globally in October. Dr Reddys, Sandoz and Apotex too were among the firms which decided to initiate recall of the drug before the formal USFDA ban.

Discovered in 1922, Metformin is a first in line treatment for Type 2 diabetes. It has been in use for over 50 years and is a part of World Health Organisation's list of Essential Medicines.

Concerns on Metformin were brought up late last year with some countries such as Canada and Singapore initially recalling specific lots of drugs. Concerns about NDMA in Metformin, however, abated, after the US drug regulator said they were not recommending recalls of the drug and that NDMA levels were 'not detectable to low’.

Companies that manufacture Metformin have said they have been sending batches to the US drug regulator for testing of NDMA levels. However, the concern is that even if lots produced by companies might be matching requirements, the US drug regulator might still issue a blanket ban on the drug, something they eventually did with Ranitidine.

Lupin, Granules shares slip; street worried USFDA may recall diabetes drug Metformin

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