Indian Pharmaceutical Firms Focus On Automation & Work Culture To Improve Quality Standards
Indudstry executives at the Indian Pharmaceutical Forum 2017 held in Mumbai saw maintaining quality standards as a key challenge
A long list of regulatory warnings received by Indian pharmaceutical companies has pushed the sector’s top executives to come together and draw attention to the need for stronger quality standards. Collectively and individually, the country’s pharmaceutical firms are working on ways to ensure their processes are in line with expectations set by global drug regulators such as the U.S. Food And Drug Administration (USFDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM).
At the Indian Pharmaceutical Forum 2017 held in Mumbai on February 23-24, the industry association (Indian Pharmaceutical Alliance) issued new Data Reliability Guidelines. The guidelines have been devised as a part of the industry group’s efforts to help domestic drug manufacturers improve quality systems.
Sun Pharma's Dilip Shanghvi said that getting 50,000 Ranbaxy employees on board, after the acquisition in 2014, had presented challenges which pushed the company to strengthen its systems and technology backbone. In addition, the company is also focused on organisation culture, which Shanghvi believes is critical.
“Culture is a critical component. Retention of people, transparency and reporting of incidents are markers of effectiveness of culture”, Dilip Shanghvi said. Sun Pharma has a common organisation policy dictating quality standards, rather than a country or geography-specific policy, he added.
Dr. Reddy’s Laboratories, which has U.S. FDA inspections going on at its three API (Active Pharmaceutical Ingredient) plants, has realized the need to focus on prevention. “We need to focus on preventing things from going wrong”, Chairman Satish Reddy said.
The company has increased communication at various levels about quality and stopped investing in old plants. In fact, it may even consider shutting down some old plants, Reddy added.
He also emphasized the need for training and skill development as a way to improve quality standards.
Cipla’s chief executive officer Umang Vohra highlighted the need for automation in laboratories, just like in manufacturing. The company has increased its efforts related to automation, he said.
To address quality concerns, the company has created a ‘root cause identification’ process and has set up solution finding teams at each manufacturing site.
Vohra also suggested a vendor-audit body to reduce multiplication of efforts across various pharmaceutical companies to audit common vendors that companies may have.
“We have really prided ourselves on our compliance record”, said Lupin’s Nilesh Gupta while emphasizing regulatory and quality challenges facing Indian pharma. He added that there is a need to “use technology and data a lot more”. The company has been trying to build an early warning system, Gupta said.
Zydus Cadila’s Pankaj Patel said that while the company has pushed automation, maintaining quality standards remains a challenge. The company is communicating with employees at all levels to ensure the significance of maintaining such standards is understood.
In a statement to the exchanges on 16 February 2016, the company said the U.S. FDA inspected its Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection, no observations were issued, signalling a clean chit from the agency.
The company has increased automation efforts over the last two years, creating tracking systems. As a way to avoid undue pressure, the company does not allow the marketing teams to directly interact with plant managers.
A summary of key comments made by executives of top pharmaceutical companies:
