Quality improvements at Johnson & Johnson was the focus of last week’s news about the company. This week, unfortunately, it’s back to recalls and warning letters. Read more »

With strong R&D capabilities and a highly educated workforce at the right price, India presents an attractive alternative to European manufacturers facing increased costs at home. Add the growing domestic pharmaceutical market and India looks like the perfect location for a partnership. Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

It was her first port of call and it was steeped in symbolism.

At 7:30 am in Mumbai on July 18, Hillary Rodham Clinton’s private, cosy tete-a-tete with 10 of India Inc’s most sought-after billionaires, was a power breakfast the likes of which the city’s corporate czars had not seen in a long time. The meeting was anything but cozy, with participants hungry to take in every morsel. Read more »

Reading the news sometimes gives me a disorienting sense of déjà vu. I know I wrote that last week, but it’s true again for a different reason. Today, French heavyweight sanofi aventis (Paris) announced that it was acquiring a majority stake in Shantha Biotechnics (Hyderabad, India). This new development follows a now-familiar pattern. Read more »

Reading the news sometimes gives me a disorienting sense of déjà vu. I felt it again when I read that Ranbaxy (Gurgaon, Haryana, India) had recalled a batch of its acne drug isotretinoin after the US Food and Drug Administration found that the product’s dissolution-test results were out of specification. Didn’t this happen once before? Read more »

The first-ever BRIC Economic Summit was held this week in Yekaterinburg, Russia, further signaling the importance of Brazil, Russia, India, and China, collectively known as the BRIC countries, in the current and future direction of the global economy. Some predict that the BRIC countries will surpass the leading economies by 2050, according to a recent New York Times article. The seeds of change already have been planted in the pharmaceutical industry, where pharmaceutical market growth in emerging economies is projected in the double-digits in 2009, compared with declining to anemic growth in established markets. Big Pharma is attuned to the shifting market dynamics. Many companies have clearly stated their strategic intent to enhance their positions in emerging markets. But what are the implications for pharmaceutical manufacturing? We may have gotten a glimpse into the future with some recent moves by Pfizer and GlaxoSmithKline (GSK). Read more »

There is a phrase in India that has become not so much a commonplace as a vulgar truism, one that people reach for quickly to describe India’s financial capital’s indomitable nature: the spirit of Mumbai. The terror attacks of November, that ripped asunder the very fabric of this resolute city, has dented that spirit. Somewhat. Read more »

Just as the ICH steering committee and expert working groups are discussing next steps for the implementation of Q10 Pharmaceutical Quality System and possible adoption of the Q8 annex to Pharmaceutical Development in Brussels this week, ASEAN’s* harmonization scheme is taking another divergent turn. Read more »

Last week’s post highlighted pharma deals that haven’t been working out due to rejected bids and stalled negotiations. On a more positive note, the past several months have also seen some successful acquisitions. This past week produced updates to some of Big Pharma’s pending pacts. Read more »