When one imagines a pharmaceutical laboratory, visions of bright lights and gleaming surfaces come to mind. It is an environment associated with precision where clinical research is meticulously enacted within rigorous pharmaceutical quality control guidelines. Much like a doctor’s office, one anticipates a certain degree of sterility. That expectation was dashed during a recent FDA inspection of a Sun Pharmaceuticals Industries drug plant in India. The facility was banned from exporting drugs to the US – their primary market – after inspectors encountered a laboratory they could only describe as “un-cleanable.”
Non-compliance Nightmare
On their tour of the Sun Pharmaceuticals plant, located in the western Indian village of Karkhadi, the FDA team found breaches of compliance that were truly shocking. Sanitary shortcomings were abundant, including numerous rodent traps, a pervasive smell of urine through pharmaceutical quality control areas, bathrooms in “total disrepair,” and evidence of human waste on facility surfaces. In addition to obvious sanitation violations, the Sun plant was also slammed with charges of false reporting. According to an FDA document known as Form 483, some workers tampered with test data and removed undesirable results. Investigators imposed the import ban in March, but the details of their investigation have only recently been made available.
Blind Leading the Blind?
Earlier this month Sun Pharmaceuticals agreed to buy Ranbaxy Laboratories Limited – a move that elicits an alarming vision of the compliance-blind leading the corruption-permissive. Ranbaxy has had its own share of negative attention this year, with 4 of its plants shut down following unfavourable FDA inspection visits. The latest intervention occurred when investigators discovered that Ranbaxy employees were consistently overwriting raw data until desirable results were “achieved.” Speaking for a Mumbai-based life sciences consulting group, Ajit Mahadevan asserts that Indian pharmaceutical quality standards are not the problem – they are for the most part, similar to those adhered to in the West. Mahadevan suggests that the problem is one of execution and oversight: “there’s a lot less intensity, perhaps, and people get away with much more.”
Promises of Corrective Measures
Sun Pharmaceuticals has responded to the FDA ban by taking corrective steps at its Karkhadi factory. Company representatives are ensuring stakeholders that wayward employees have been disciplined and dysfunctional equipment replaced. Some of the FDA complaints were related to garbage and manufacturing waste found in the areas surrounding factory buildings, and Sun officials are seriously considering closing the location altogether. Issues related to non-compliance have plagued Sun for several years – in 2009 its Detroit based factory was temporarily closed after repeated product recalls. On the whole, India’s pharma industry seems to be facing major reputational challenges. Last year alone, the FDA banned over 20 facilities from exporting drugs to the US. Do you think effective oversight of pharma production is even possible in an increasingly globalized marketplace?