Johnson & Johnson has said it will not enforce patents on its HIV drug Prezista (darunavir) in Africa and other poor regions of the world.

The decision will ensure that many patients have access to cheaper generic versions of the drug.

However, J&J insists that generic darunavir must be of high quality, and reserves the right to enforce its patents if this is not the case.

The company has declined to join the new Medicines Patent Pool, which aims to accelerate generic drug production.

J&J came second in the Access to Medicine Index 2012, which scores major pharmaceutical companies on the access to their drugs in poorer countries – seven places higher than its 2010 placing.

Multiple generic manufacturers will now be able to produce generic darunavir for sale in sub-Saharan Africa and other ‘least developed countries’.

The drug is a second-line therapy for patients who have developed resistance to the standard antiretroviral drugs. Demand for it in Africa is increasing rapidly.

Paul Stoffels, J&J’s Head of Pharmaceuticals, said that competition between generic manufacturers would drive down the price of darunavir.

Indian pharmaceutical companies would be particularly quick to bring out generic versions of the drug, he predicted.

Stoffels defended the decision to stay out of the Medicines Patent Pool: “We want to reserve the right to reinforce patents if people are not providing the right quality of product, for example by bringing products to market that under-dose.”

India’s Health Ministry has ordered states to stop licensing branded medicines, aiming to restrict the country’s drug market to generics.

From now, pharmaceutical companies applying for a licence to market or manufacture drugs in India will have to submit the generic name – over which they have no exclusivity.

The policy is a response to a threefold increase in healthcare costs over a decade, and will radically affect the pharmaceutical industry’s footprint in one of the world’s fastest-growing markets.

According to the Drug Controller General, Dr G.N. Singh, “We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public.”

The Government is also seeking to increase the availability of free medicines through public health clinics, reducing the private sector market – which currently dominates drug purchasing in India.

A WHO study found that 20–40% of India’s public health clinics had adequate stocks of generic medicines, compared to 40–60% of private clinics.

About 72% of healthcare expenditure in India is money paid by individual patients for drugs.

Healthcare expenditure tripled between 1994 and 2006, while individual income rose only by two-thirds.

Drug prices rose by 40% between 1996 and 2006, with increased drug consumption having more economic impact than price rises.

India and China are set to become the drug industry’s global hubs for Contract Manufacturing Organisations (CMOs).

The governments of both countries have changed their business and regulatory frameworks to encourage pharmaceutical outsourcing from other countries.

A new report from business intelligence source GBI Research says the global drug CMO market will grow steadily as Western pharma companies outsource their production to Asia.

The global drug CMO market is predicted to grow from $26bn in 2010 to $60bn in 2018, with outsourcing of biologics and generics being the main growth areas.

India and China in particular have benefited from the development of factories that meet global regulatory criteria for drug manufacturing.

In 2005, India’s Biotechnology Policy simplified procedures for regulatory clearance and granted exemptions from import duties and service taxes, while a new patent regime made it easier for pharmaceutical companies to protect their intellectual property rights in India.

China’s State Food and Drug Administration (SFDA) has stated contract drug manufacturing to be a long-term economic goal. The legal framework for contract manufacturing in China on behalf of countries outside China was introduced in 2001 and refined in 2003.

India’s health ministry has claimed that ‘systemic improvements’ in the country’s drug approval procedures are needed, following a report on alleged corruption.

The parliamentary report alleges irregularities in the approval of drugs from major pharmaceutical companies, including major gaps in clinical evidence.

Companies including Eli Lilly and Bayer have challenged the accuracy of the report, which focuses chiefly on the failings of India’s drug regulator.

The Central Drugs Standard Control Organization (CDSCO) lacked adequate staffing or resources, the report found, and there was evidence of a “collusive nexus” between its officials, drug companies and medical experts.

An example cited was CDSCO’s acceptance of three expert opinions on Bayer’s anti-thrombosis drug rivaroxaban that were identical copies. Bayer responded that it had not played “any role in selecting these experts or evaluating their opinions”.

The report also claimed that CDSCO routinely approved drugs that were not approved in the EU or the US due to lack of clinical evidence.

Critically, it said that of 39 CDSCO-approved drugs it surveyed, 11 had not been tested on patients in different ethnic groups – a key requirement of approval in India.

An example was Lilly’s lung cancer drug pemetrexed – but the company insisted the drug had been tested on a large multi-ethnic patient base.

Irregularities claimed in the approval of drugs from Lundbeck, GSK and Novartis were similarly denied by the companies concerned.

The controversy reflects the growing importance of India and other ‘emerging markets’ for the global pharma industry.

Daiichi-Sankyo has agreed a $500m legal settlement with the US Food and Drug Administration (FDA) for manufacturing violations by its Ranbaxy unit.

The Japanese company, which acquired India-based company Ranbaxy at the end of 2008, has halved its net income forecast for this tax year.

The FDA charges include falsification of data to cover up inadequate and potentially dangerous manufacturing controls at two Ranbaxy factories in India making generic drugs.

To help compensate for the company’s income loss, Daiichi’s board of directors have agreed to cut their individual pay for the next six months, with directors losing between 5% and 30% of their salaries.

The settlement is subject to approval by the US District Court for the District of Maryland, but Daiichi expects that it will resolve all civil and criminal charges raised by the FDA.

The FDA investigation into Ranbaxy’s at Ranbaxy’s Dewas and Paonta Sahib plants in India began in September 2008, when the FDA warned the company that ‘serious manufacturing deficiencies’ could be affecting over 30 generic products.

Problems reported included inadequate protection against cross-contamination of drugs; inadequate control records; and inaccurate written records of the cleaning and use of equipment.

Daiichi acquired Ranbaxy in November 2008.

In February 2009 the FDA halted reviews of drugs manufactured at the Paonta Sahib site, commenting that that there was a “pattern of questionable data raising significant questions”.

Ranbaxy has said that it will address the issues raised by the FDA by improving its manufacturing and data management practices.

Arun Sawhney, CEO of Ranbaxy, commented: “While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes.”

VistaMed’s investment of €7.2 million in R&D and product expansion will create 79 jobs, nearly doubling its workforce.

The Irish company designs, develops and manufactures catheters and complementary medical devices, exporting to the UK, Europe, US, South America and India.

Paddy Mulholland, Managing Director of VistaMed, said that the company “has continued to develop its capabilities and today we offer a comprehensive design development and manufacturing of innovative catheter solutions”.

The company’s investment is supported by the government through Enterprise Ireland.

Currently, 93 people are employed by VistaMed at its facility in Leitrim.

Sanofi Pasteur has invested $300 million in plans to open a new vaccine manufacturing plant in India by March 2012.

The new plant aims to help expand the company’s vaccine capabilities, following the acquisition of India’s Shantha Biotech for $784 million in 2009.

However, the deal carried manufacturing defects forced by the WHO to cancel pre-qualification of the vaccine Shan5, costing Sanofi hundreds of millions of dollars.

But Chris Viehbacher, CEO of Sanofi, said to the Business Standard: “We have implemented all the corrective measures. And we are quite positive about the relationship with Shantha and will be participating in global tenders once the pre-qualification process is completed for low-cost and high-quality vaccines.”

By 2015, Sanofi expects 30% of its total sales to come from the US, 33% from Europe and the rest from emerging markets.

Andrew Witty, GSK Chief Executive, has said the company is eyeing up new investments in the Indian pharmaceutical market.

In an interview with The Times, Mr Witty outlined plans to purchase assets of up to £2bn as it looks to increase its presence in one of the world’s largest emerging markets.

But Mr Witty ruled out any large-scale takeovers was as the company already has an “enviable” brand in the country.

Glaxo currently employs 5,000 people in India with a turnover in the country of more than £1bn.

The Indian pharmaceutical market in the country was recently reported to reach $55bn a year by 2020. In 2009, the market was worth around $12.9bn.

GSK is not the first company to invest in the Indian market. Sanofi recently announced a deal to acquire Universal Medicare’s over-the-counter unit in the country. India’s The Economic Times also reported that Takeda is in takeover talks with the generic drug manufacturers Cipla and Lupin which are based in the country.

The FDA has approved Lupin Pharmaceutical’s generic version of UCB’s Keppra XR tablets for the treatment of epilepsy in patients aged 16.

The levetiracetam drug is indicated for adjunctive therapy to treat partial onset seizures following final approval from the FDA for its abbreviated new drug application (ANDA) to market the treatment option in the US.

The 500mg and 750mg extended release tablets are the AB-rated generic equivalent of Keppra XR.

Lupin Ltd said in a statement that commercial shipments of the product have now commenced.

Keppra’s annual sales were estimated at $161 million for a twelve month period ending in June 2011, based on IMS Health sales data.

The India-based pharmaceutical company produces a range of generic and branded formulation and APIs for distribution worldwide, involving market shares in cardiovasculars, diabetology, asthma, paediatrics and anti-infectives.

Sanofi’s Indian unit, Aventis Pharma, is in talks over a takeover deal for the over-the-counter (OTC) division of Universal Medicare.

The deal is rumoured to worth around five billion rupees ($109m) and would see Sanofi gain around 30 of Universal Medicare’s brands, worth up to $25m in sales.

A Reuters source says the deal is expected to be completed within a couple of days.

India’s OTC market is growing at an annual rate of between 17-18%.

Sanofi has been branching into emerging markets and strengthening its consumer health business to offset the loss of sales to generic alternatives to its best selling products.

The company is not the first to target OTC markets in emerging markets. Last year Reckitt Benckiser acquired Paras Pharmaceuticals for $726 million, while Johnson & Johnson in May agreed to buy several Russian-market over-the-counter brands from India-based JB Chemicals and Pharmaceuticals.