After the recent US Food and Drug Administration (FDA) episode involving Ranbaxy
, there is a general apprehension that Indian-made medicines and drugs are sub-standard and that middle-class India is buying and consuming drugs that are questionable in quality. In fact, parents of young children are reluctant to give any drugs to them, fearing that they are sub-standard.
For Piramal Healthcare, quality manufacturing and operational excellence is critical for the safety of patients taking medicines made in our plants. I recall asking my Quality Control Group whether we could face FDA complaints. The clear answer was, "It is highly unlikely." The team cited the multiple times the US FDA and other agencies such as the UK-MHRA (Medicines and Healthcare products Regulatory Agency), have inspected our plant at Pithampur (in Madhya Pradesh) and our Digwal plant near Hyderabad. They recalled the tremendous effort and investment that was made to get them to US FDA standards. We are also audited by our customers, which comprise large pharmaceutical companies, several times a year.
What is important about maintaining the highest quality standards and the highest integrity? It is the ethical culture of the organisation, independent reporting of quality, investment in continuous improvement, training of staff, and getting the values imbibed in each employee, even the lowest in the line function.
In our company, the ethical culture deeply pervades the organisation. The active whistleblower policy goes directly to the board, which goes into great details, on any complaints. The quality operations function reports directly to the Executive Director, and not to any line manager, who is responsible for sales and profits. The quality operation is, therefore, totally autonomous and independent.
The quality standards of global regulators are a constantly moving bar. They change every year and, therefore, education of personnel on continuous improvement, adhering to new standards and training are critical. We have a robust system of training and audits conducted by both internal and external experts. Of course, zero error is difficult to achieve. But it is a mighty goal in the search for excellence.
Integrity is vital in any health-care business, where we are saving lives when patients use our medicines. At Piramal, workers, even at the lowest level, are involved in continuous improvement. Operational excellence is rewarded. At 14 Piramal plants, from where products are exported to over 100 countries, many foreign regulators visit frequently. The quality team takes pride in having no major deficiencies or warning letters in the US FDA audit system. Workers are encouraged to report aberrations and deviations promptly. Such an open culture helps to quickly identify issues, and is less costly, in the long run.