Express Pharma

The quest for quality continues

It is considerably more difficult to live up to these professed codes of conduct off stage, as it needs to flow right from the CEO/promoter to every employee at every location of the company

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Quality was once again in the spotlight at two recent industry meets. While regulators kept their sights on raising the compliance bar, industry chiefs pledged adherence to these codes. Not surprisingly, most speakers focused on the importance of trust. At the Indian Pharmaceutical Alliance’s (IPA) virtual 9th Advanced Good Manufacturing Practices (GMP) Workshop Dr Rajeev Raghuvanshi, Drugs Controller General of India, CDSCO, Government of India commented, “At the heart of the pharmaceutical industry lies one unwavering principle: Quality. It’s not just a goal; it is the foundation of our global leadership, and the trust placed in us. The world is increasingly looking towards India, not just for our contributions to generic medicines, but for our growing leadership in advanced areas like biologics, medical devices, and digital health.”

Nilesh Gupta, Chair, Quality Forum, IPA and Managing Director, Lupin spoke about how “our industry’s reputation, and more importantly, the trust of millions of patients worldwide, are built on the cornerstone of quality. It is encouraging to see that the Indian pharmaceutical sector is making significant strides towards becoming a global benchmark for quality through capability building, process improvements, talent development, digitalisation, and fostering a quality-first mindset.” A few days later, IDMA’s 23rd Pharmaceutical Analysts Convention (PAC), had the theme: “Quest for Sustainable Quality – IDMA Leads the Way.” Chairing a session titled, CEO’s Vision on Sustainable quality, Mehul Shah, honorary Secretary General, IDMA and CMD, Encube Ethicals alluded to the ”power of compounding” in India’s pharma industry but also made the point that quality is a challenge, unless the sector transitions from reactive to proactive regulatory compliance, both seen and unseen. Therefore if companies demonstrated a quality mindset on a voluntary basis, it would build trust. 

Bhushan Akshikar, MD, GSK Pharmaceuticals India’s comment that the company’s 100 years in India landmark coming up this November, is because the company is now not just “a trade mark but a trust mark” made the point that trust requires time to build up, but also needs consistency through the decades.

Dr Viranchi Shah, national president, IDMA and Director, Saga Laboratories’s comment about the need for “smart/optimal regulation” as “under regulation puts patients at risk, over regulations could weaken industry” reiterate the need to balance the economic viability of compliance measures with patient safety. Mid-size companies have often seen more stringent regulations as an unfair business practice, as it strains their resources, while larger counterparts can absorb compliance related capex much better.

Pranay Godha, MD, & CEO, IPCA’s analysis that “the quality journey is about leaders asking uncomfortable questions …seeking discomfort. The standards that you walk past, are those that you accept ” also struck a chord with the audience. 

But it is considerably more difficult to live up to these professed codes of conduct off stage, as it needs to flow right from the CEO/promoter to every employee at every location of the company.

DCGI Raghuvanshi summed it up best when he advised, “Quality should be at the core of strategy. The moment we shift from quality to profitability the company suffers. Quality is not episodic, it should be part of the DNA of the company. Quality is one of the ingredients of the product. Due to competition, we have started compromising quality with cost. It is actually a fight between Saraswati (the goddess of knowledge) and Lakshmi (the goddess of wealth). Keep Saraswati in front, Lakshmi will follow. It is never vice versa. Keep quality in front, profits will follow.”

That is an apt message to reflect on this Deepavali. The Express Pharma team wishes all readers a happy and safe Deepavali. May the light of knowledge mark our continuing journey along the path of quality affordable medicines.

VIVEKA ROYCHOWDHURY, Editor

 [email protected] 

[email protected]

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