Generic drug manufactures to pay more for registration in US

US FDA recently made amendments to introduce a generic drug user fee. According to the new law, The Generic Drugs User Fee Amendment (GDUFA) of 2012 — companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.

According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File companies are required to pay $21,340.

OTC sale of around 92 antibiotic and anti-TB drugs will be clamped down in India soon

Resistance to antibiotics is becoming a serious threat to Indians because of popular habit to pop pills at will which is an irrational use.  A recent study by the Centre for Disease Dynamics, Economics and Policy, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

In order to avoid such irrational use, DCGI has written to the Union health minister to notify a new schedule H1 in the Drugs and Cosmetics Rules. Once notified and following the clearance from the law ministry, these drugs cannot be sold without prescription. These drugs will also have to carry a prominent label in red colour with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

This is a very welcome news as we and world, staring at a post-antibiotic era, when common infections will no longer have a cure.

Source : Media reports