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Maharashtra FDA detects widely prescribed anti-bacterial cream with wrong label of imported ingredient

Shardul Nautiyal, Mumbai
Saturday, February 11, 2023, 08:00 Hrs  [IST]

In a first-of-its-kind case, the Maharashtra Food and Drug Administration (FDA) has detected a case of spurious anti-bacterial cream widely prescribed to treat minor skin or external infections, cuts and burns with wrong label of imported ingredient.

The ingredient being used is neomycin sulphate and is wrongly labeled with the superior quality imported costlier ingredient framycetin sulphate, according to regulatory experts. Such cases were detected long back in 1995 with state drug controller’s inspections having revealed that the spurious cream manufactured had neomycin sulphate content instead of the original framycetin sulphate cream. Indian manufacturers do not have the capability to manufacture the key ingredient used in the cream by the name framycetin sulphate which is generally imported.

The antibacterial cream has a strong brand recall and is known popularly with the brand name Soframycin skin cream which has a legacy of more than 50 years in India with a vast distribution network. Soframycin and its associate brands acquired by Encube Ethicals represented 2.6% or Rs. 60 crore of the total sales of Sanofi India's sales in the year 2020. At present, the brand is sold through a network of over 3,000 distributors and 550,000 retailers across the country.

No pharmaceutical company in India has been authorized to import framycetin sulphate as the major manufacturer Sanofi had sold the brand to Encube Ethicals. Headquartered in Mumbai, Encube Ethicals was founded in 1998. With its facility in Goa, Encube is the largest single site facility dedicated for dermatology products globally.

The spurious cream is marketed by Aarti Life Science LLP, Mumbai, Maharashtra and manufactured by Swiss Garnier Life Sciences, Baddi, Himachal Pradesh. Samples were drawn by the Maharashtra FDA from Milton Genext LLP, Kalher Village, Bhiwandi, Thane with Batch Number 2310SF001, manufacturing date – August 2022 and expiry date July 2024.

The sample drawn and tested by the Maharashtra FDA gave additional identification test for the presence of neomycin sulphate. Content of neomycin sulphate found in the sample is 1.198% w/w. The sample has been declared as spurious vide section 17-B of the Drugs and Cosmetics (D&C) Act 1940 and Rules, 1945.

 




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