Policies & Legislation
Generics may be allowed to change drug labelling
FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers.
Fourth US state rejects law restricting biosimilar substitution
Maryland has become the fourth US state to reject legislation that could restrict pharmacists’ ability to substitute cheaper biosimilars for their reference biologicals.
Lundbeck and 4 generics makers fined for pay-for-delay deals
The European Commission (EC) announced on 19 June 2013 that it had fined Danish pharmaceutical company Lundbeck and four generics makers for pay-for-delay deals in Europe.
India lists API exporters with written confirmation
The Indian drugs regulator has published a list of manufacturers for which it has granted written confirmation that the active pharmaceutical ingredients (APIs) comply with the European Union’s (EU’s) good manufacturing practice (GMP) requirements.
EU lists Japan as having equivalent GMP standards
Japan is the latest country to join Australia and Switzerland on the European Union’s (EU’s) list of countries that comply with its good manufacturing practice (GMP) requirements.
US Supreme Court backs FTC in pay-for-delay case
On 17 June 2013 the US Supreme Court ruled 5-3 in favour of the Federal Trade Commission (FTC) in the case of FTC versus Actavis with respect to reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.
Indian Government moves closer to complying with EU API rules
On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutical ingredients (APIs) into the EU that takes effect on 2 July 2013.
EU to fine 9 drugmakers over pay-for-delay deals
The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.
Ireland passes bill to encourage generics use
On 22 May 2013, the Health (Pricing and Supply of Medical Goods) Bill 2012 was passed by both Houses of the Oireachtas (Irish Parliament).
India introduces new drug pricing control
On 15 May 2013, India’s Directorate of Food and Drugs Administration announced the introduction of a new Drug Price Control Order (DPCO), which is expected to lead to price reductions of up to 80% in ‘essential drugs’.
