USFDA Doubles Down on its Criticism of Indian Pharma
At a recent ‘Advanced GMP National Workshop’, the USFDA presented a very distressing paper titled “Current Trends in Quality and Data Integrity — Is it a Myth or Just the Tip of the Iceberg?”
The fact that there has been a steady rise in the number of warning letters being issued to Indian Pharmaceutical companies is no longer surprising.
Also not surprising was the fact that India and China are once again the top two countries which have been served the most number of warning letters by the FDA, for yet another consecutive year.
What is particularly significant however, and a little more concerning, about this latest paper, are the detailed specific issues with quality control that were presented.
The seven main issues the FDA paper points out are:
- Releasing failed products as though they have passed Quality Checks
- Testing into Compliance, which essentially means companies would keep testing until a positive result is achieved
- Destroying all hard and soft copy evidence of failed tests
- Disabling audit trails so there would be no way to trace the failures
- Inadequate investigation into “out of specification” issues
- Inadequate Corrective & Preventive Action
- Root cause lacking scientific evidence
Going through these points, there are three glaringly obvious issues at the core of the Pharma industry’s woes — unacceptable work culture, an inability to be proactive, and the motivation of only meeting production goals, no matter the cost.
Work Culture
The work culture problem in the industry is a long time affliction. There are many fundamental reasons why the workforce is uninspired, unmotivated and eventually careless. The culture in the workplace doesn’t seem to encourage group dynamics, and instead creates unhealthy interpersonal competition which forces workers to cut corners and take unnecessary risks.
The work culture needs to be improved from the ground up, using all the tools available to the industry today — from technology to behavioral sciences to help understand what motivates the workforce and encourage them to work towards a bigger organisational goal.
Inability to be Proactive
A large company cannot always protect itself from a crisis, and damage control is sometimes unavoidable. That being said, it is always more beneficial to be proactive and prevent at least those issues that pose a clear and present danger to the organisation either in the short or long term.
Being proactive does involve a little more effort, but the rewards far outweigh any amount of labour that takes. And once the company’s quality culture begins to improve, the crises with compliance and warning letters will be a thing of the past. Most of the companies that have received warning letters could easily have avoided them by choosing to proactively address the issues instead of “getting by”, and then reactively covering their tracks afterwards.
Being Driven Purely By Production Goals
Citing “symptoms and foundational problems”, the USFDA paper goes on to say that there is a very basic “lack of understanding of science” within these organisations. The main motivation for companies seems to be purely meeting production targets, no matter what the cost.
This symptom could once again be attributed to a poor work culture, where quality excellence is not encouraged, and instead employees are pushed only to meet production goals.
The “fix” for this is simple — create a culture of quality excellence — where each and every employee is encouraged to strive for quality over quantity, bringing to them a sense of ownership of the company, and a loyalty to the brand. While this may sound simple, it is easier said than done, and requires well thought out planning and integration of systems that make the employees’ voices heard, making them feel valued at the organization.
This latest USFDA paper, presented to more than 400 delegates from the Pharma and other industries in India, is yet another wake-up call for the industry. It must be taken seriously, and changes to the work culture must be improved industry-wide. While it won’t be an overnight task, the industry finally has access to business solutions consultants like SEEK, who can help them understand the pain points, evaluate the risks and create realistic business goals based on those evaluations.
Eventually, organisations in the Indian Pharma sector need to work towards aligning their people and processes with their business goals, and in doing so, create a work culture that not just meets global compliance and regulatory standards, but far exceeds them, making India a global leader in the Pharmaceutical Industry.
