News

India’s population is growing rapidly—as is its economy—creating a large middle class with the resources to afford western medicines. This fact has seen a spate of western companies stepping forward to make agreements with Indian generics manufacturers in order to get a foothold in this developing market.

General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of branded statins in favour of cheaper generic alternatives according to a report in Pulse.

The UK’s Health Secretary, Mr Andrew Lansley, has issued a GBP 220 million (Euros 246 million; US$360 million) lawsuit against French drug company Servier for allegedly ‘abusing’ its dominant position and delaying rivals from launching generic versions of its angiotensin-converting enzyme inhibitor, perindopril (Coversyl).

Drug shortages are at a record high, and some blame the policies of the FDA for causing some of these. However, good news is on the horizon as US drugmaker APP Pharmaceuticals has decided to boost its manufacturing capacity for injectable generic drugs. This could help to fight against the growing list of drug shortages reported by the FDA.

The US Supreme Court has decided that generics makers cannot be sued under state law for not changing their labels to warn of possible side effects. That is a big victory for Actavis, Mylan and Teva, which had faced appeals against court rulings that would have allowed them to be sued under state law.

Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent exclusivity expired in Spain, Ranbaxy Laboratories announced that it had launched its generic version of the treatment.

In response to an article by Professor Philip Clarke in the Australian Financial Review titled Time to slash cost of generics, Medicines Australia Chief Executive Dr Brendan Shaw hit back saying that ‘the price of generic medicines on the Pharmaceutical Benefits Scheme (PBS) is already being reduced by as much as 70%.’

While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Zentiva.

On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.

Dispute with EU resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.