Maha FDA raids chem co; Rs 40 lakh worth illegal drugs seized

Maharashtra's Food and Drug Administration (FDA) seized illegal drugs worth Rs 40 lakh during raids at premises of Pioma Chemicals in Mumbai and Thane.

The raids were carried out at the company premises in Vile Parle (East) and at their godowns at Prerana Complex, Anjur Road, Bhiwandi, in Thane district after a tip-off, FDA Commissioner Dr. Harshadeep Kamble, told PTI.

"Pioma Chemicals imported Lactitol Monohydrate USP / EP, a drug illegally without registration and import license, as required under provisions of Drugs and Cosmetics Act 1940 and rules," Kamble said.

"Acting on this information the premises were raided and stock of 12,730 kg of Lactitol Monohydrate USP / EP which is prohibited and worth Rs 40 lakh, was seized," the senior IAS officer said.

"Primary investigation has revealed that Pioma Chemicals gave an undertaking to the Centre about the import of this dual use drug for the purpose of 'not for medicinal use'", he said.

Though this raw material can be used as bulk sweetener for manufacture of low calorie food products, it is also used as an active ingredient in drug manufacturing, he added.

This drug is used for treatment of constipation, prevention of encephalopathy, fissures, hemorrhoids, hyper cholestrolaemia, anorectal disease, etc, said Kamble.

Pioma Chemicals also gave an undertaking to the Central Government agency, CDSCO, that the said material will not be used or sold for medicinal purpose and that they will take similar undertaking about 'not for medicinal use' from the purchaser on said product, he said.

The drug is imported from Shandong Lujian Biological Technical Co. Ltd., China and is sold to various pharma companies like Sun Pharma, Medley Pharma Ltd., Tirupati Medicare, Akums Drugs and Pharmaceutical Ltd., he said.

Investigation has also revealed that Pioma chemicals have imported more than 3 lakh kilograms of the drug worth Rs 10 crore, he said.

According to the IAS officer, as per provisions of Drugs and Cosmetics Act and Rules, import of drug requires registration of the manufacturer.

In this case since the manufacturer is based in China, registration for import will make their manufacturing facility available for audit and inspection by the Indian authorities, he added.

It also requires import license for import of drug to be issued by licensing authority of the Centre. The import of drugs without license is prohibited as per provision of sec 10 (c) read with rule 23, 25, 25 (b), 26 of the Drugs and Cosmetics Act and Rules, informed Kamble.

As the drug has been supplied to the manufacturers located in various states of the country, I have informed the concerned State Drug Controllers to verify and investigate the matter with respect to stock received by manufacturer located in their jurisdiction, said Kamble.

He also said that notices were issued to the users/ manufacturers of Lactitol Monohydrate USP/EP, namely Sun Pharmaceuticals Ltd., Medley Pharma Ltd., Tirupati Medicare, Akums Drugs and Pharmaceutical Ltd.

Sample of the drug has been drawn for test and analysis to ascertain the quality of the drug imported illegally, he added.

The Drugs Controller General of India, New Delhi has been informed about the issue to conduct further enquiry, if necessary separately, and for reviewing the policy of issuing no objection certificate for import of dual use drugs, particularly for Lactitol Monohydrate USP / EP by Pioma Chemicals, Mumbai, said the officer.