FDA seizes chemical worth ₹42 lakh from pharma company near Mumbai

FDA officials said that in 3016-17, the illegal drug import scam ran into Rs10 crore. It has sent notices to several other firms too.

The Food and Drugs Administration (FDA) of Maharashtra has sent notices to a major pharmaceutical company for using imported food sweeteners in medicines, after it seized chemical stock worth Rs42 lakh from another company in Bhiwandi.

After receiving a tip off about illegal imports, FDA officials recently raided 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. (Representational picture)

FDA officials said that in 3016-17, the illegal drug import scam ran into Rs10 crore. It has sent notices to several other firms too.

After receiving a tip off about illegal imports, FDA officials recently raided 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.

This is illegal under provisions of the Drugs and Cosmetics Act 1940, FDA said. During the raid 12,730kg of Lactitol Monohydrate USP / EP (sugar alcohol used as a low calorie sweetener in food) worth Rs42 lakh was seized.

“Primary investigation has revealed that the company had given an undertaking to the central government saying that they would import the drugs but “not for medicinal use”. Although this material can be used as a sweetener for the manufacture of low calorie food, it is also used as an active ingredient in drugs,” said Dr Harshdeep Kamble, FDA commissioner.

Officials revealed 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. The company imported the chemical from a Chinese company and sold it to different pharmaceutical companies to be used in medicines.

“We have issued notices to the pharmaceutical companies and asked them to submit details about the batches of products made from the particular chemical. A sample of the said drug has been sent for analysis,” said Dr Kamble.

When HT contacted the pharmaceutical company, its spokesperson did not want to comment on the issue immediately and asked for some time