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Pharma exports to surge as Revised Schedule M norms poised to enhance quality: Pharmexcil DG

Shardul Nautiyal, Mumbai
Tuesday, April 2, 2024, 08:00 Hrs  [IST]

In a decisive move towards bolstering quality standards, India's stringent regulation in the form of Revised Schedule M norms is poised to cultivate a culture of excellence within the pharmaceutical industry adding heft to the growth of pharma exports from India. This landmark development underscores India's unwavering commitment to ensuring the highest standards of safety and efficacy in pharmaceutical manufacturing, paving the way for sustained growth and global credibility, said Uday Bhaskar, director general (DG) of the Pharmaceuticals Export Promotion Council of India (Pharmexcil).

He was speaking on the sidelines of a comprehensive one-day capacity building workshop organized by Pharmexcil in collaboration with Goa Food and Drug Administration (FDA) and Central Drugs Standard Control Organisation (CDSCO) at Panjim in Goa on March 27, 2024.

Heralding the revised Schedule M norms as a transformative milestone in the industry's quest for quality supremacy, he emphasized that these regulations would serve as a catalyst for nurturing a culture of meticulous compliance and continuous improvement, thereby fortifying India's position as a reliable provider of quality medicines to over 200 countries worldwide.

Against this backdrop of regulatory fortification, India's pharmaceutical exports have witnessed a remarkable ascent, surging by over 9 percent between April and February of the fiscal year 2023-24. Notably, exports to the United States, a pivotal market for Indian pharmaceuticals, have exhibited robust growth, soaring by over 15 percent during the same period.

The confluence of stringent regulation, relentless pursuit of quality, and resilient supply chain dynamics underscores India's unwavering commitment to global healthcare excellence. As India's pharmaceutical exports continue to scale new heights, propelled by adherence to rigorous quality norms and market-driven innovations, the nation reaffirms its pivotal role as a beacon of pharmaceutical prowess on the global stage.

Bhaskar recently delivered a resounding call to action on the occasion of emphasizing the imperatives of quality assurance and strategic market expansion. Reflecting on past incidents, Bhaskar underscored the industry's steadfast commitment to stringent quality standards, stressing their pivotal role in ensuring patient safety and preserving the credibility of Indian pharmaceuticals on the global stage.

Contaminated cough syrups exported from India to Gambia and Uzbekistan have unveiled critical lapses in quality control, igniting apprehensions over the safety of pharmaceutical products emanating from the Indian market. The emergence of tainted batches has thrust the spotlight on India's pharmaceutical industry, prompting urgent calls for heightened vigilance and robust regulatory measures to safeguard global health.

Furthermore, Bhaskar articulated the necessity for industry stakeholders to remain abreast of regulatory dynamics, particularly those pertinent to the Indian market. He advocated for a culture of unwavering quality consciousness, asserting that only through diligent adherence to evolving regulations could the industry sustain its integrity and competitiveness.

Expounding on market dynamics, Bhaskar delineated promising avenues for expansion, with Africa emerging as a cornerstone of growth. He elucidated the region's vast population and conducive economic conditions as fertile ground for pharmaceutical exports, underscoring the need for concerted efforts to capitalize on burgeoning opportunities.

In the wake of the cough syrup contamination crisis, Uday Bhaskar reaffirmed the industry's unwavering resolve to uphold quality benchmarks and fortify India's stature as a bastion of pharmaceutical excellence. His words resonated with a sense of urgency, signaling a collective commitment to rectify systemic shortcomings and reaffirm India's reputation as a trusted provider of essential medicines worldwide.

Moreover, Bhaskar emphasized the need for industry players to stay updated with regulatory amendments, particularly those pertaining to the Indian market. He urged pharmaceutical companies to cultivate a culture of quality consciousness, which would facilitate compliance with evolving regulations and standards.

Discussing market expansion, Bhaskar outlined the emerging opportunities in key export destinations. He highlighted Africa as a crucial market with significant growth potential, citing the region's population size and economic conditions as favorable factors for pharmaceutical exports.

Furthermore, Bhaskar underscored the importance of diversifying export focus beyond traditional markets like the USA and Europe. He noted Latin America and Africa as regions where Indian pharmaceuticals have established a strong reputation, owing to the industry's history of supplying essential drugs at affordable prices.

In response to the crisis of contaminated cough syrups, Uday Bhaskar reiterated the industry's commitment to continuous improvement and global outreach. He emphasized the need for sustained efforts to uphold quality standards, ensuring India's prominent position in the global pharmaceutical landscape.

As investigations into the contaminated cough syrups continue, stakeholders remain vigilant, advocating for transparency, accountability, and continuous improvement in pharmaceutical manufacturing practices. The incident serves as a reminder of the importance of prioritizing patient safety and maintaining the integrity of the global pharmaceutical supply chain.


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