FDA Notice to Pharmaceutical Firm for Using Imported Sweeteners

After the seizure of chemicals worth Rs 42 lakh from a chemical company in Bhiwandi last week, the Food and Drugs Administration (FDA) of Maharashtra has now sent a notice to a major pharmaceutical company for using imported food sweeteners in medicines without license.

According to information from the FDA, the pharma company, located in Bhiwandi was illegally selling ‘Lactitol Monohydrate’ chemical from China to many pharmaceutical companies. “After receiving a tip off about illegal imports, raid was conducted at the premises of the Bhiwandi company and found that it was importing the chemical as an ingredient for food products, but selling it to pharmaceutical companies for use in medicines,” said official.

A senior official of FDA said that selling the chemicals without license is illegal under provisions of the Drugs and Cosmetics Act 1940. “During the raid 12,730 kg of Lactitol Monohydrate worth Rs 42 lakh was seized,” added official.

Dr. Harshdeep Kamble, FDA commissioner said that the company had also given an undertaking to the Central Drugs Standard Control Organization (CDSCO) saying that the material would not be used or sold for medicinal purposes.

"During the investigation it was revealed that the company had given an undertaking to the Central government saying that they would import the drugs but not for medicinal use. But the company imported the chemical from a Chinese company and sold it to different pharmaceutical companies so that it will be used in medicines," added Dr. Kamble.

Dr. Kamble further stated that the notices has been issued to the pharmaceutical companies and asked them to give the complete details about the products. “The samples which have been seized are sent to the laboratories for analysis,” added Dr.Kamble.