Mumbai: Drugs Controller General of India (DCGI) has directed all state drug controllers (DCs) to keep a strict vigil on illegal import of Ansell Encore Underglove Latex Surgical Gloves manufactured by US based Ansell without registration certificate (RC).
Central Drug Standards Control Organization (CDSCO) issues RC for sale in the Indian market as per the provisions of the Drugs and Cosmetics (D&C) Act.
DCGI directive comes in the wake of a letter from Abhay Pandey, president, All India Food and Drug License Holders Foundation (AFDLH) to the CDSCO stating that products of Ansell named Encore Underglove Latex Surgical Gloves with claims like skin moisturising technology that helps retain moisture and rehydrate dry skin is being imported in Mumbai port office without having RC as provisioned under D&C Rules, 1945.
According to the DCGI notice to the state DCs, “This is to inform state DCs that the said product has not been registered by CDSCO and therefore state DCs are directed to keep a strict vigil on import of such cosmetic products in India. Action taken in the matter may please be informed to the CDSCO office.”
The ingredients or substances or chemicals contained in Encore Underglove fall in both pharmaceutical and cosmetic categories and product is also being widely used in most medical practices.
For importing such a product into India, it is mandatory to register under the D&C Act and the import law on the basis of end use details.
Continuous import of this product is a violation of the D&C Act 1940 and Rules 1945, Goods and Services Tax (GST) 2017 and import duty respectively which is also badly impacting taxes and duties of related departments.
“It is sold indiscriminately in the open market and in government hospitals,” according to sources.