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Drugs controller clarifies on fixed dose combination of streptomycin 

Anju Ghangurde  
Mumbai, July 10: The Drugs Controller General of India has, in line with a ruling by the Supreme Court, maintained that an earlier notice aimed at phasing out the fixed dose combinations (FDC) of streptomycin and penicillin will not be applicable the veterinary version.

The Supreme Court of India had considered a host of review petitions in this regard and allowed the use of FDC for veterinary use. In its order, the apex court says, "Pending further orders, we direct our order dated April 15, 1996, will not be applicable to the FDC of streptomycin and penicillin for veterinary use. It is made clear that any FDC of streptomycin and penicillin which is sold for veterinary purposes must contain explicitly and in bold letters on the packaging that the said medicine is meant for veterinary purposes and would be dangerous/hazardous for use by human beings and it is not permissible for use by human beings".

The government of India, ministry of health and family welfare had earlier, in a gazette notification dated February 25, 1997 ordered the phasing out the FDC of streptomycin and penicillin by January 1, 1998 as per directions of the Supreme Court. The key drug brands in this segment include Sarabhai's Dicrysticin S, Alembic's Pistrepen, Hindustan Antibiotics Streptopenicillin and Vysali's Streptocillin.

Meanwhile, in another notice the DCI has also decided to "keep in abeyance till further direction," a notification regarding streamlining of drug formulations of iron tonics and enzyme preparations by August 31, 2000 as per the recommendations of the Drugs Technical Advisory Board (DTAB).

The DCI said that a number of representations had been received from manufacturers explaining the rationality of the higher dose of elemental iron in iron tonics and the justification for the addition of zinc in such preparations.

"Following a preliminary examination of representations by experts, it has been considered appropriate to examine such representations in consultation with the DTAB. The matter is being referred to the expert committee of the DTAB. The recommendations of this committee would then be examined by the DTAB for taking a final view," the DCI said. The latest position on this could, however, not be got.

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