Malaika U Shenai
19th October 2020
Sun Pharmaceutical Industries Limited (Sun pharma), the Indian pharmaceutical company, hit a wedge with their generic diabetic drug in the United States after the Food and Drugs Administration (FDA) claims that they deviated from the current acceptable manufacturing practices.
Sun Pharma (Source: Livemint)
Sun Pharma’s drug contains N-nitrosodimethylamine (NDMA). According to the FDA, impurities in them probably are a carcinogenic substance in a human body based on lab results. There are no adverse effects caused as of yet due to the presence of NDMA. They also found environmental contamination found in water and food, including meat, dairy products, and vegetables. NDMA, when released to soil, is highly loose and has the potential to leach into groundwater. Overexposure to NDMA indicates headache, fever, nausea, vomiting, abdominal crunches, enlarged liver, and reduced function of the liver.
There are no adverse effects caused as of yet due to the presence of NDMA. The Hindu reported that The tDA has classified it as a class-2 recall, which is initiated ‘due to the usage of, or exposure to a violative product that may create temporary or medically reversible adverse health consequences or raise the probability of serious adverse health consequences or where the probability of serious adverse health consequences is remote’.
Due to the raised contamination of NDMA, in 2018 and again in 2019, multiple valsartan brands were recalled. Also, in 2019, ranitidine was recognized across the world due to contamination with NDMA. The drug that has been under question is Riomet ER. It is metformin hydrochloride and is usually prescribed as an oral medication for people with type-2 diabetes. This drug is used to improve their blood glucose control. According to the FDA, elevated levels of NDMA are shown in the extended-release of metformin formulation but not in the immediate-release formula.
As reported by the Hindu, Manufactured at Sun Pharma’s Mohali plant, these products are a United States-based subsidiary that recalls it. Sun Pharma has recalled 747 bottles of this drug from the market to stop circulation. Sun pharma started recalling this drug from the market on September 23, 2020. After the FDA claimed that the drug was harmful, many multi million companies started identifying their products. Lupin and Granules India recalled almost 9.71 lakh bottles of generic diabetes drugs in the United States, reported Economic Times. Sun Pharma’s stock price has been seen to fall after the news broke out. It is seen to go down by 2.12 per cent to ₹513 at 8:30 pm on October 11.
(Sources: The Hindu, India Times, Economic Times)
Edited by: Keyuri