Weathering the trials of quality and data integrity compliance in the Indian pharmaceutical sector

1_130x130The Indian pharmaceutical sector has seen immense flux in recent times in the form of stricter regulations, price control, contract manufacturing, mergers and acquisitions and foreign investments among others. Regulators around the globe, such as United States Food and Drug Administration (US FDA), the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA), World Health Organisation (WHO) Indian Food and Drug Administration and others have started keeping a closer watch on this sector, given the developments. Particularly in terms of drug safety, quality and compliance, there has been an increase in enforcement action such as surprise inspections on manufacturing facilities and issuance of warning letters by foreign regulators such as US FDA, UK MHRA and others.

Even the regulators are revisiting the current requirements and formulating new guidance and policies to streamline the global pharmaceutical industry. Such action is compelling drug makers in Indiato assess their state of compliance and ensure that they do not come in the line of fire.

Pharmaceutical companies are also facing challenges through various stages in the drug manufacturing process. These range from discovery to clinical trials; noting the data for quality assurance to distribution – everything is now closely watched.

Following are some of the key industry concerns faced by the Indian industry in the area of current Good Manufacturing Practices (cGMP) compliance:

  1. False or incomplete data records – Capturing and recording data real time is a pre-requisite during the drug manufacturing or formulation process and many regulators worldwide have mandated compliance to the integrity of data maintained by the drug manufacturers. Majority of the warning letters or Form 483s issued by the US FDA mention cGMP violation in respect to false or incomplete data recorded by the quality teams. Companies would need to have stricter protocols to ensure data recorded is real time, accurate and reviewed by authorized personnel.
  2. Lack of adequate training –  It has been observed that at times, employees are forced to compromise on the acceptable quality levels in order to meet production targets or despatch timelines of a particular batch or product. This not only raises concerns in the minds of regulators about the quality of the product, but also tends to indicate compromises on the documentation itself – for if the pressure is so high on manufacturing, who takes care of timely and accurate documentation? It is imperative that companies train not just employees but also the management to drive the concept of quantity “over” quality, and instead focus on quantity “with” quality. Further, trainings should have more focus on actual understanding and compliance instead of just a tick in the box to meet training requirements.
  3. Weak IT and laboratory systems:  Companies are required to have robust IT and lab systems so that there is no unauthorised access or potential of manipulation of records in Quality Control (QC) laboratory.  The US FDA has clearly mandated compliance with 21 CFR Part 11 for electronic records of companies to have controls, and ensure that the records and signatures are trustworthy, reliable and equivalent to paper records. A similar guideline has been issued by UK MHRA as well. It is important that the management pays greater attention to these requirements, as failure to do so can invite regulatory and/or penal actions on the company.
  4. Inefficient investigation systems:  Several warning letters issued by US FDA in India have cited insufficient Corrective and Preventive Action (CAPA) programmes to the Form 483s as a major compliance gap seen in many companies.  Hence they need to reassess their compliance frameworks and work on CAPA programmes while dealing with any customer complaints or product deviations or Out of Specifications (OOS) and Laboratory Incident Report (LIR) that have come under the scanner. A successful CAPA should entail proper documents procedures, use of best practices and robust IT systems to track complaints so that there is no room for errors or penal actions.

To mitigate any potential regulatory action, companies should look to initiate proactive data integrity reviews. Data integrity reviews conducted periodically can provide a greater level of assurance around the state of compliance or remediation to all stakeholders involved – customers, investors and regulators as well as reaffirm the management’s commitment toward highest standards of quality. Companies need to rethink their commitment to quality and compliance – and if need be challenge their business, manufacturing and testing processes – all this to build and have a sustainable business in the future.

Click here to download our report, Analyzing the state of Data Integrity Compliance in the Indian pharmaceutical industry

Follow @EY_India and track #EYForensic for regular updates


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