‘Qualiminds Hopes To Improve The Indian Drug Industry’s Image’

K. Anand, CEO and managing director, Qualiminds, tells BW Businessworld that the pharmaceutical industry’s attitude to compliance with regulatory norms has to change

What hampers quality compliance in the Indian drug industry?
Several factors have caused compliance failures in recent years. Means to achieve quality through an integrated and robust quality systems management has been absent in several companies. These factors include poor development of processes in research and development, poor culture of adhering to quality, inadequate training of employees to consistently perform as per stated procedures, poor stress on ‘contemporaneous’ data recording of events pertaining to manufacturing and testing, over-dependence on manual operations, lack of periodic oversight on quality, etc.

Do you see quality standards turning more stringent in future?
Even though quality standards, or guidelines of the United States’ FDA or European Union agencies, have not changed significantly in recent years, the agencies have become more vigilant about data integrity issues in Indian companies. Data alteration or change without valid justification, and inability of employees to preserve or demonstrate the trail of all supporting primary data related to manufacturing and testing, have led to enforcement actions by US FDA in recent years

The inspection process has certainly become more stringent too. Now we have more ‘unannounced’ inspections, which are more investigative than before.

What kind of constraints deter the industry from following quality standards consistently?
Indian industry needs to change its mindset towards compliance. Although pharma managers are knowledgeable about the standards and guidelines for compliance, poor application of that knowledge in day-to-day work and lack of emphasis on training operating personnel, causes serious issues. Shop floor managers also need to overcome pressures from senior management on delivery targets...

How costly are remedial measures for non-compliance with regulations?
Remedial measures are not really expensive or costly. At a nominal increase in cost, companies can improve the level of automation wherever possible, for facilitating the audit trail of events or records and minimize human elements in data entry errors. Measures should be taken to protect primary data, be it automated or manual, and that is not expensive. All it takes is – building more accountability into the system and empowering QA personnel at sites to take hard decisions.

Will the scenario change now that skillsets for remedial measures are available locally in India?
We need to bring about a change in mindset towards compliance at all levels at this stage. The promoters and senior management of the companies have to be sensitive and concerned about day-to-day operational issues in manufacturing and quality assessment processes.

What is Qualiminds’ vision and how will you make your presence felt in the market?
Qualiminds hopes to improve the Indian drug industry’s image in the eyes of international regulators on quality of products, processes and practices. With the help of an experienced and competent team at Qualiminds, we aim to strengthen awareness of various quality management systems, train personnel to write simple and practical SOPs, create awareness of how to undertake validations of equipment and processes, assist in creating understanding of failure investigations, among others. Our key strength will be the relevant experience of our team members, each one of whom have gone through dozens of FDA and EU inspections across 25 odd years in the industry.