If it isn’t bad enough that, thanks to regulatory changes including the new drug policy, the growth of India’s pharmaceuticals sector is down to sub-10%, the US FDA action against Wockhardt has further dented its global image. The immediate impact, of course, will be financial—among the drugs that can’t be exported from the Chikalthana plant is the bestseller blood pressure medicine Metropol that accounts for a seventh of Wockhardt’s revenues. But given this is Wockhardt’s second brush with the FDA in the last six months, there is a lot more at stake. Indeed, given that India is the biggest supplier of medicines to the US—at $4.23 billion, FY13 exports jumped a third over FY12—the FDA is stepping up its presence in India in a big way. It has three offices in India and is reportedly planning a fourth to keep tabs on the 526 FDA-approved facilities India has.
One way to look at the FDA action is to say that just 9-10% of Indian sites are under threat and, given the number is comparable to China and much lower than for countries like even Canada and the UK, there isn’t much cause for worry. The other, more realistic view, is that with more such actions, India’s ability to capture the huge US market looking to outsource relatively inexpensive medicines is getting badly hit.
Even more worrying is what this says about the quality of medicines that are being supplied in India. As compared to the US FDA’s over 10,000 staffers, India’s Central Drugs Standard Control Organisation (CDSCO) has just 124 staffers versus its sanctioned posts for 1,375 people; and while various state government agencies have 3,200 drug inspector posts sanctioned, the actual number is under 900—to oversee 10,500 manufacturing sites and over 6 lakh retail sales outlets. At current staffing levels, just to visit a plant/chemist, let alone doing a detailed audit over months, will take a few years. Hardly surprising then that, as per industry estimates, anywhere between 20% and 30% of India’s pharmaceuticals are fake.