Clinical trials for generics proposed

EVEN AS INDIAN drug-makers have heaved a sigh of relief with the United States' decision to shelve the plan to extend the tariff hikes to generic medicines, a key change is in the offing in domestic regulations that will spell trouble for them.

- MANU KAUSHIK

The country's drug regulator - Central Drugs Standard Control Organisation (CDSCO) - has proposed to close the easy route for pharmaceutical companies to quickly launch generic versions of "new drugs" by just proving that these are bio-equivalent to the innovators' drugs.

Experts said that the move has come in the wake of growing pressure from the Donald Trump administration to reduce the non-tariff barriers for US companies in India.

IF THE PROPOSAL, made in a "note for public comments" released by CDSCO, is converted into a rule, the launch of generic drugs will also require submission of separate data on clinical trials, just as the "new drugs" do. Clinical trials are much more expensive and time-consuming than the bioequivalence studies. Currently, once a new drug is approved based on clinical trials and BE data, the generic companies simultaneously submit the BE study report with the regulator, and obtain approval for their version of the drug.

However, this puts the innovator company at a disadvantageous position as there is a lack of level-playing field, the CDSCO said in the note.