New Delhi: Azim Premji's Wipro Enterprises has approached the drug regulator of India's office seeking exemption from the applicability of revised Schedule M after the Karnataka State Drugs Control Department issued it a notice for compliance of Schedule M for their Tumkur facility that manufactures their disinfectant floor cleaner brand-Maxkleen.
India's top drug advisory board will take up the matter in its upcoming meeting and give its recommendations regarding the case.
Wipro has sought relaxation in requirement of Schedule M for specific categories like disinfectants.
The product, Maxkleen, has been registered as a drug. The company has asked to allow them to manufacture the product without a drug licence.
"We state that this product does not kill insects or vermin. The product purports to repel the insects but not kill the insects. As per Section 3(b)(ii) of Drugs & Cosmetics Act, 1945, the drug includes a substance used in destruction of vermin or insects. Our product has a claim of killing 99.9 percent of germs but does not claim to the insects and vermin as per the definition of drug," said the letter to the Drug Controller.
It further said that in case the authorities believe that they can continue to manufacture Maxkleen under a drug license, "We humbly submit that the requirements of Schedule M are not applicable for the manufacture of a floor cleaner/ disinfectant. Schedule M title itself states that it governs pharmaceutical products," the letter further said.
According to Wipro their product Maxkleen is a "simple floor cleaner" and doesn't aim to cure any disease in humans or animals.
India's top drug advisory board will take up the matter in its upcoming meeting and give its recommendations regarding the case.
Wipro has sought relaxation in requirement of Schedule M for specific categories like disinfectants.
The product, Maxkleen, has been registered as a drug. The company has asked to allow them to manufacture the product without a drug licence.
"We state that this product does not kill insects or vermin. The product purports to repel the insects but not kill the insects. As per Section 3(b)(ii) of Drugs & Cosmetics Act, 1945, the drug includes a substance used in destruction of vermin or insects. Our product has a claim of killing 99.9 percent of germs but does not claim to the insects and vermin as per the definition of drug," said the letter to the Drug Controller.
It further said that in case the authorities believe that they can continue to manufacture Maxkleen under a drug license, "We humbly submit that the requirements of Schedule M are not applicable for the manufacture of a floor cleaner/ disinfectant. Schedule M title itself states that it governs pharmaceutical products," the letter further said.
According to Wipro their product Maxkleen is a "simple floor cleaner" and doesn't aim to cure any disease in humans or animals.