Major repair may be needed to fix quality culture in some firms

Written by Pallavi Ail | Updated: Jan 18 2014, 05:55am hrs
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 Indias 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 needed for the quality cultures in certain companies. Any attempts to cut corners by compromising GMP place patients at risk and will damage the reputation and prospects of the company concerned. The responsibility for developing and maintaining a quality culture lies primarily with the most senior management.

The message needs to cascade loud and clear from the CEO to the whole organisation that nothing less than good practice and integrity are acceptable.

What do you think of the skills of the workers employed in the Indian units Do you think they are adequately trained

In general, there is an adequate level of skill work force in most Indian facilities. MHRA have noted that there is a higher percentage of casual/temporary staff vs permanent employees used within Indian facilities when compared to those in the UK. On occasions the MHRA has noted that the training of these staff is not as detailed as expected with them receiving a lower level of training than permanent employees.

Have you observed any shortcomings on management of companies to keep themselves updated on the latest compliance rules and regulations

This is an issue for some companies but not others. It very much depends upon how a company has established its quality system and management structure to keep on top of regulatory change. Clearly it is harder for companies based outside of the UK/EU to keep on top of changes in the UK/EU. The MHRA is committed with other international regulators through publications, presentations and training programmes to provide as much help as possible. An example of this is the MHRAs major contribution to a forthcoming series of WHO training events at the end of January in three major Indian cities.

Compared with the US FDA, UKMHRA is not seen to be stepping up its inspections in India. Are there plans to increase the scrutiny

The MHRA has a risk based inspection programme which schedules sites according to risk this frequency is not determined on geographic locality. We continue to undertake around 50 inspections each year in India. We do not have any permanent employees based in India, however, we are able to get inspectors to India rapidly if needed.

Have the violations made UKMHRA wary of granting approvals to new facilities Will you be more strict with new facility approvals

The MHRA has always inspected against compliance with EU GMP and if sites from anywhere in the world are found to be failing we will take necessary regulatory actions. This action includes not initially approved for supply to the EU or restricting or removing their ability to supply into the EU.

Can you please give the number of inspections conducted in India since 2010 on an yearly-basis

The numbers of MHRA inspection performed are, 54 in 2010, 50 in 2011, 57 in 2012 and 43 in 2013. In addition to MHRA inspections, approximately 120 GMP certificates were issued by other EU member states in 2013.