Western regulators have increased scrutiny of Indian drug manufacturing manufacturing plants to check if they adhere to good manufacturing practices. Apart from the US FDA, which has banned several facilities of Ranbaxy from exporting drugs, recently the Medicines and Healthcare Products Regulatory Authority, United Kingdom (UKMHRA) shot into prominence after its action against Mumbai-based Wockhardt. Both regulators repeatedly state inadequate documentation and poor hygiene standards at India’s manufacturing facilities. Edited excerpts from an interview by Pallavi Ail with Gerald Heddell, director of inspection, enforcement and standards, UKMHRA.
What are the issues you believe occur frequently in Indian manufacturing facilities?
There have been a number of critical GMP failings found during recent inspections of certain major Indian companies. These have been well publicised in the press. The most serious recurring issue is evidence that analytical data relating to batch release and ongoing stability testing has been falsified. The most obvious explanation for falsified data would be that there is an understandable desire to present clean and tidy documents and that paperwork which has been spoilt has been rewritten. Unfortunately, evidence discovered by our inspectors indicates that it is sometimes not as simple as that and in some cases, the data has been fabricated or altered. Needless to say, any falsification of data is entirely unacceptable. When discovered, the MHRA has taken steps to remove the products from the UK market and has issued a statement of non-compliance which effectively stops supply to the whole European Union.
Are you concerned with the state of affairs at Indian drug manufacturers?
Indian pharmaceutical companies are very important suppliers of medicines and active substances to the UK. No less than a quarter of all UK medicines are made in India and almost 40% of all product licences for UK medicines cite an
Indian sources of active substance.
The majority of Indian drug companies which supply the UK operate to internationally acceptable standards and are a reliable source of quality medicines. This is evidenced by our inspections which have a generally good outcome for 90% of sites. However, the MHRA has become increasingly concerned about a minority of key suppliers quality systems and practices fall below the standard we expect.
Do you believe there are systemic manufacturing problems in the Indian pharma industry?
We have no evidence that there are systematic manufacturing problems in the Indian pharma industry. However, there are worrying signs that a major repair job is