The Union health ministry has amended the Drugs and Cosmetics Rules to include zinc sulphate tablets and oral solutions having 10 mg and 20 mg of elemental zinc under Schedule K of the Drugs and Cosmetics Act for exemption from the sale licence provided the drug has been manufactured under a valid licence.
In a gazette notification dated 30th August, 2013, the health ministry through Drugs and Cosmetics (Fourth Amendment) Rules, 2013 exempted zinc sulphate tablets and oral solutions having 10 mg and 20 mg of elemental zinc from the “provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence, subject to the condition that such a product has been manufactured under a valid drug manufacturing licence.”
The Union health ministry's action in this regard comes following a decision to this effect by the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, which deliberated on the issue in its last meeting held on July 24 this year. Earlier, the matter was also considered by the Drugs Consultative Committee (DCC) in its 44th meeting held on July 20, 2012 and it also recommended that zinc tablets of 5 mg and 10 mg should be granted exemption under Schedule K from the requirement of sale licence provided the drug has been manufactured under a valid licence.
Experts in the ministry feel that the use of zinc tablets in childhood diarrhea is considered essential and easily achievable public health goal in India. It has been recommended by the health organizations like UNICEF, WHO, PATH and AIIMS. Like ORS, zinc has the possibility of making a major impact on the health of children in India by controlling the childhood diarrhoea.
Besides, an expert committee in 2006 and a conference organized by Clinical Development Service Agency (CDSA) and Department of Biotechnology (DBT) in 2011 had advocated for the inclusion of zinc products under schedule K to ensure consistent and easy availability and promotion of these products.