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Rules to be amended to include zinc sulphate tablets in Sch K for exemption from sale licence

Ramesh Shankar, Mumbai
Friday, September 14, 2012, 08:00 Hrs  [IST]

The Union health ministry will soon amend the Drugs and Cosmetics Rules to include zinc sulphate tablets and oral solution IP of 5 mg and 10 mg 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.

A decision to this effect has been taken 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.

Drugs Controller General of India (DCGI) Dr GN Singh informed the members of the DTAB in the meeting that the use of zinc tablets in childhood diarrhea has been 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.

Dr Singh also informed the DTAB meeting that 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.

After detailed deliberations, the DTAB agreed to the proposal of the CDSCO to amend the Drugs and Cosmetics Rules to include zinc sulphate tablets and oral solution IP of 5 mg and 10 mg 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.

 

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