All your translation are belong to us

From the quality control page of Shanghai Ju Peng Translation Co., a representative sample:

★1．We have a sound and stable pool of translation team, tasks of translation are strictly selected and assigned in accordance with languages and specialty fields.

★4．We track up and monitor text pieces in the course they are being translated, and deal with and resolve all the way those key points and pitfalls involved; project team is so created whenever for any large project of translation work and senior translators, professors or foreign experts are initiated to be in charge of jobs of aligning, tuning glossary and of ensuring texts consistent to the style of overall work translated.

★5．Once pieces of translation completed, there are other translators assigned to conduct follow-up proofreading in order to eliminate occurrences of usual errors as letter omission, mistranslation, wrong figures and improper typeset.

If you need work, offer to clean up their copy....

Ranbaxy? Wow.

The effluent has finally hit the fan. Ranbaxy has stonewalled the FDA for ages to keep records relating to quality audits at its manufacturing facility in Paonta Sahib secret, but the FDA seems to have lost patience: yesterday it banned the importation of anything produced at Ranbaxy's plants at both Dewas and Paonta Sahib. From an FDA press release:

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States....

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products.

That's shocking. As the FDA's press release says, Ranbaxy is one of the biggest importers of generics into the US. The action casts doubt on the standards of all Indian drug manufacturers, who have worked for years to improve their reputation. It was only months ago that the heparin disaster raised the possibility that offshoring might be proceeding to quickly. Anyone considering outsourcing the manufacture of their API to India will factor this example into their calculation of risk. They will already be considering the rising costs of India and China, where inflation is over 10%.

I wonder how Daiichi Sankyo feels about their acquisition now-- as if it hadn't been hard enough to get Japanese to use generics....

"It's in the national interest"

It's no secret that Beijing's primary objective for the Olympics is to show the world how far it has come. However, the country's efforts to present a "perfect" event ironically highlight exactly what continues to hold China back -- a systemic focus on appearances over substance. The opening ceremonies offered an interesting example. The organizers wanted a child to sing "Ode to the Motherland," but while 7-year-old Yang Peiyi was judged to have the best voice, she did not have the best looks, so they had 9-year-old Lin Miaoke lip sync the song. "The audience will understand that it's in the national interest," said Politburo member Chen Qigang, expressing the delusion, common to the totalitarian mindset, of complete control of perception. Apparently the fireworks weren't good enough for the Politburo, either, according to the same piece:

The news follows reports that some footage of the fireworks exploding across China's capital during the ceremony was digitally inserted into television coverage, apparently over concerns that not all of the 29 blasts could be captured on camera.

As a friend of mine who sent me the piece observed, the philosophy of development in China seems to be "just look the part". He added: "This is evident every time you hear about lead poisoning, food poisoning, water poisoning etc. They even think they can get away with mimicking drugs because one chemical *appears* to have properties like another completely different chemical."

The problem is fundamentally one of leadership. Until the Politburo rewards substantial value and rejects mere appearance, "made in China" will continue to inspire suspicion.

Up-and-coming Chinese CROs

Seeking Alpha today notes an interesting development that highlights two up-and-coming Shanghai CROs. Morningside Venture, Lilly Asian Ventures and Pfizer Venture Investments have all put their money behind the Shanghai-based, bio-focused CRO HD Biosciences Inc. HD seems to have a close relationship with Sundia, another Shanghai-based CRO that focuses on drug discovery chemistry. The two announced a service alliance with Novasecta in February, and with United PharmaTech in 2007.

Lonza's new engineering business

Lonza is starting up a new engineering business that will focus on China. It'll offer engineering, design and maintenance. Quite an interesting way of embedding the company in an expanding market and supplier base. Lonza will raise the production standards of any company they work with. They'll know exactly how the Chinese customer does business, and whether they'd make a good partner (or even acquisition...) for the Swiss fine chemicals leader. It'll be interesting to see how widely the service is engaged. Considering Lonza's reputation, compared with that of Chinese producers, I would think that the main limiting factor will be the price tag. Being able to point to a relationship with Lonza should be a valuable selling point for Chinese companies looking for business in abroad, particularly in the West & Japan.

“This new business unit is a very logical expansion of our existing strengths in manufacturing of complex products. We have built chemical and biotech plants around the world, at very high levels of quality and regulatory compliance,” remarked Lukas Utiger, Head of Life Science Ingredients. “We have built strong project management and maintenance experience in China since the mid 1990’s for the construction and maintenance of cGMP and Food GMP plants which have been certified by global regulators. Our talented and highly qualified staff of 130 technical experts has a strong drive to capitalize on this new business opportunity.”

The elephant in the pill bottle

A US Senator is hot and bothered about outsourcing by big pharma, says a piece at Outsourcing-Pharma, and the Congressional Record may shortly feature some interesting info:

Sen Brown has asked for specific information on the mechanisms Merck uses to track the chain of custody for reach ingredient used in its products, procedures to check that each facility in the supply chain adheres to its operating procedures and standards, and whether the US Food and Drug Administration (FDA) “periodically inspect every facility” that makes ingredients for the company.

He also asks for a detailed breakdown on the percentage of production that is outsourced to US providers, a ranking of the top 10 countries the company outsources to, and the estimated average and median wages paid at companies producing active pharmaceutical ingredient s(APIs) for Merck in each country.

He's done the same thing to Pfizer, apparently scandalized by something he found in the 2Q results, specifically a big hike in profits “due in part to cost-cutting measures,” Outsourcing-Pharma notes. Maybe he can't be blamed. According to the website, an FDA official made a serious accusation.

In April at a meeting of the Senate Health, Education, Labor and Pensions (HELP) Committee, says Brown, an FDA official “acknowledged that American drug companies outsource operations due to cost factors and the existence of weaker drug safety standards abroad.”

Or maybe Brown just didn't understand what he was being told at the time. He certainly doesn't seem to understand the drug industry. He seems to think that Pfizer's 17% outsourcing should be called "heavy reliance". Has he looked at the generics industry? Obviously no, because he probably would have had a stroke over 100% outsourcing.