BioAsia 2023: Experts call for improving drug, device quality

From the challenges India is facing regarding drug and device quality to the initiatives the country has to take to increase the quality

Hyderabad: From the challenges India is facing regarding drug and device quality to the initiatives the country has to take to increase the quality, to be on par with Global drug and devices, and many others, the panel of seven eminent speakers from the field shared their views at BioAsia 2023.

Mark Abdoo, Associate Commissioner for Global Policy and Strategy, US FDA; Dr Carmelo Rosa, Director, Division of Drug Quality, CDER, US FDA; Dr Sarah McMullen, Country Director, India, FDA; Prof Sarfaraz K Niazi, Adj. Professor of Pharmaceutical Sciences, University of Illinois, Chicago, USA; Ian White, Executive Director, NSF Health Sciences and Former GMDP Inspector, MHRA UK; Pavan Kumar Mocherla, EVP & President Greater Asia, BD, and Michael Cutter, Chief Quality Officer, Biocon Biologics, participated in the panel discussion on ‘India for India and India for the world: Where does quality stand?’ moderated by Ekta Batra, Anchor & Associate Editor Research, ‘CNBC-TV18’.

---

Speaking about improving resource quality and her perception of India as a pharma hub, McMullen said, “Investing in quality will give you the best ROI. We are hoping for a more proactive model than a reactive one. You need strong regulations – Regulators should grow as the industry grows.” When it comes to regulatory standards among drug regulators, the push is for global harmonisation of quality standards, McMullen added.

Addressing India’s role in importing medical devices to other regulated countries, Kumar explained that there were a couple of MedTech companies that are adhering to the quality standard and the country was still progressing in this regard.

Adding to this, Abdoo remarked that there was certainly an interest in moving the manufacturing of drugs and devices back to the US. “The interest is there but there is going to be a considerable length of time before we get there. We will facilitate an enabling environment as a government,” he added.

While Cutter expressed that there is a huge generational change in India, which provides a huge opportunity for youth to embrace, and for the country to be the pharmacy of the world, Abdoo remarked that the government has to increase its budget in that space to support India’s aspirations.