Health Min­istry dis­tin­guishes stem cell-ther­apy from drugs

BioSpectrum (India) - - POLICY AND REGULATORY NEWS -

To en­sure un­hin­dered ac­cess of ‘stem cell ther­apy’ for treat­ment by physi­cians, the Union Health Min­istry has pro­posed to statu­tory dis­tin­guish it from ‘stem cell drugs,’ mak­ing the lat­ter alone li­able to the usual screen­ing and trial runs stip­u­lated for new drugs.

Ap­pris­ing an in­ter­na­tional con­fer­ence on stem cells of the govern­ment’s move, Drug Con­troller Gen­eral of In­dia S Eswara Reddy stated that the Union Health Min­istry has pro­posed amend­ments in the Drugs and Cos­met­ics Rules, 1945 to reg­u­late the Stem Cell-based drugs.

The pro­posed amend­ments would de­mar­cate ‘stem cell- based drugs’ from the ‘stem cell ther­apy’ and en­sure that the physi­cians us­ing the lat­est med­i­cal tech­nique in treat­ment is not legally in­con­ve­nienced. The pro­posed amend­ments to the Drugs and Cos­met­ics Rule, 1945, de­mar­cat­ing ‘stem cell drugs’ from the ‘stem cell ther­apy’ have been in­cor­po­rated in the Gazette of In­dia pub­lished on April 4.

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