''Nitrosamines''-Is this compound a blow to Pharma Industry..??

 If you go back to 2018, Nitrosamines presence in the drug product were not known to the World. But since then, when  USFDA found the presence of Nitrosamines in the drug Products like Valsartan and Ranitidine, It became talk of the year in Pharma field. 


                          Nitrosamines are the class of compounds which are usually found in the meet. This compound is considered as cancer causing agent in a research conducted by International Agency for Research on Cancer( IARC). Nitrosamines are probable cancer causing agent to humans.It was first found by USFDA in a valsartan Active Pharmaceutical Ingredient(API) manufacturer from china.

             The game started when, All the regulatory authorities like FDA, EMA, WHO,Health Singapore and even Indian CDSCO started to issue orders to the manufacturers to recall their products from the market and submit the products for analysis. All the hypertensive drugs, Anti diabetic drugs were recalled from market. The major companies which got blow are Sanofi Pharmaceuticals, Strides Shasun LTD, Aurobindo Pharma, Dr. Reddy's and many more..

                    These companies recalled their drug from market and sent the batch for analysis, but till then they were already had incurred with a huge loss and reduction in share price. The Authorities have tested batch and clarified that the Nitrosamines are present within the limit. The drugs list goes like; Valsartan, Losartan, Irbesartan,Candesartan etc. These developments have made the Authorities very stringent in regulation of drugs and taken strict measures in testing and approval for market. Meanwhile the Pharmaceutical companies also have become alert about the advancement and from the ground state, i.e from sourcing raw materials to final stage testing and packaging they are giving dew care. In-fact these are the good signs for health of population.

                              In the end its better to say a few words on what should be known by the people who takes medication. FDA states that patient safety is their top priority. They have said in their recent update that dont be panic, FDA is doing their job and checking for Nitrosamines in the drug. If the medication which is being consumed by you is been recalled, Please check for alternative medicine and nothing to worry. OTC prescriptions shall be changed to alternative medication. To know if your drug has been recalled, contact the nearest pharmacies, ask pharmacists or even can mail the FDA.

                               

                                

Comments

Popular posts from this blog

Types of Registration Application for Pharmaceuticals in Japan: In a nutshell

Association of South East Asian Nations CTD( ACTD)- A overview

Tools and Technologies used in eCTD submission