Maha FDA takes action on illegal import of drugs meant for therapeutic purpose

The action was taken based on the information that Pioma Chemicals has imported Lactitol Monohydrate USP / EP, a drug illegally without registration and import license, as required under provisions of Drugs and Cosmetics Act 1940. 

Primary investigation has revealed that Pioma Chemicals has given the undertaking to the central government about the import of this dual use drug for the purpose of “not for medicinal use”. Although this raw material can be used as bulk sweetner for manufacture of low calorie food products, it is also used as an active ingredient in manufacturing of drug. 

The said drug is used for treatment of constipation, prevention of encephalopathy, fissures, hemorrhoids, hyper cholestrolaemia, anorectal disease, etc. Pioma Chemicals has also given the undertaking to the Central Drugs Standard Control Organisation (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 of said product. 

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

Investigation has also revealed that Pioma Chemicals has imported more that 3 lakh kilograms of said drug worth Rs.10 Crore. 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. 

It also requires import license for import of drug to be issued by licensing authority of the Central Government. 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. 

Since, the said drug has been supplied to the manufacturers located in various states of the country, Maharashtra FDA Commissioner Dr Harshadeep Kamble informed the concerned state drug controllers to verify and investigate the matter with respect to stock received by manufacturer located in their jurisdiction. 

Dr. Kamble said, “Notices have been issued to the users and manufacturers of said Lactitol Monohydrate USP / EP, namely Sun Pharmaceuticals Ltd., Medley Pharma Ltd., Tirupati Medicare, Akums Drugs and Pharmaceutical Ltd etc. Sample of the said drug has been drawn for test and analysis to ascertain the quality of the drug imported illegally”. 

He further added that the matter has been appraised to the Drugs Controller General of India (DCGI) to conduct further enquiry, if necessary separately in the said matter 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.

Maha fda, illegal import, drugs meant, therapeutic purpose