The Indian pharma industry needs to learn from mistakes and develop innovative solutions for a foolproof quality standard mechanism to give a fitting reply to the regulators. According to Shudhanshu Pandey, Joint secretary, Department of commerce, Government of India, the Indian pharma industry needs to inculcate a culture of openness and give space to commit mistakes and learn from them to give fitting reply to the regulators.
With western regulators eyeing high on the Indian pharma industry, the global generic maker is facing stiff challenges in terms of regulatory blockade for Indian pharma exports abroad. Particularly, the recent warnings from the United States Food and Drug Administration (FDA) and export hurdles from EU have become stumbling blocks in the way of India’s smooth drug exports to the western world.
Advocating that the Indian pharma industry should inculcate the habit of learning from mistakes, Pandey said, “Indian pharma industry should learn from the mistakes and inculcate a culture of openness. It should allow space to commit mistakes and learn from them. New and innovative solutions to these mistakes will not only help the industry to have a foolproof quality system but can also help it give fitting reply to the regulators.” Pandey was interacting with industry leaders at chief executive officer, conclave in Hyderabad recently.
Particularly the western world, EU and USA are looking at the Indian pharma industry with suspicion on various pretexts. Of late, the recent warnings from the US FDA to various drug companies in India and regulatory strictness from European Union to Indian imports have had great impact on the Indian exports. Be it IP, proper documentation, packaging and drug quality in every segment, the industry is facing a lot of pressure from the western world.
Though some industry experts viewed that US and EU governments are pressurised by their Industry leaders not to allow Indian products into their market because of huge pricing competition, a few others pointed out that Indian industry should not give chance for the western regulators to point fingers.
“Indian pharma industry has shown tremendous resilience and flexibility in the past. We need to accept the criticism positively and rebound back with foolproof standards. This will help us to become more robust and continued efforts in this direction will help bring a positive change about India’s perception among the west,” said the joint secretary.