Gov­ern­ment of In­dia an­nounces Na­tional Pharma Pol­icy draft

BioSpectrum (India) - - POLICY AND REGULATORY NEWS -

With the aim to boost do­mes­tic man­u­fac­tur­ing of drugs, levy cap on trade margin, crack­down on un­fair mar­ket­ing prac­tices and limit

'loan li­cens­ing' by pharma com­pa­nies, the gov­ern­ment of In­dia has con­scripted Na­tional Pharma Pol­icy draft.

The new draft pol­icy also fo­cuses on creat­ing a na­tional list of es­sen­tial medicines with the tar­get of keep­ing the reach­able and rea­son­able. This step could be marked as the be­gin­ning of a new era in In­dian phar­ma­ceu­ti­cal sec­tor. The pol­icy also talks about set­ting up of a Na­tional Phar­ma­ceu­ti­cals Pric­ing Author­ity (NPPA).

The draft also aims to cre­ate an en­vi­ron­ment suit­able for re­search and de­vel­op­ment.

The cen­tre also plans to pre­scribe rules for brand­ing drugs. Com­pa­nies will be al­lowed to put brand names only on fixed-dose com­bi­na­tions. For all other drugs, they will be asked to print only the generic names.

The Author­ity is set to lose its au­ton­omy with in­crease in in­ter­fer­ence from the gov­ern­ment. While the pol­icy says, “The reg­u­la­tor and the gov­ern­ment would be two dis­tinct agen­cies. The gov­ern­ment shall not be the reg­u­la­tor and the reg­u­la­tor shall not be the gov­ern­ment,” yet a gov­ern­ment-ap­pointed ad­vi­sory body, with rep­re­sen­ta­tion from the gov­ern­ment, in­dus­try, as well as civil so­ci­ety, is be­ing pro­posed.

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