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Regulatory Compliance Improving in Indian Pharma

Indian pharma industry has seen improved approvals and regulatory compliance over the years. The industry has understood the regulatory expectations and has invested significantly in strengthening its infrastructure to match the regulatory needs, noted Indian pharma industry leaders at the CEO Conclave held at the second day of BioAsia here. Speaking at the conclave, Zydus Cadila chairman Pankaj Patel said, “Industry has crossed the stage when its data integrity was questioned. Companies in India have taken action to become fully compliant. We are comparable to any regulated nation in the world.” He further added, “Indian pharma industry’s share of regulatory observations is much lesser than companies of other nations taking into account the country has second largest number of US FDA approved facilities.” Satish Reddy, chairman, Dr Reddy’s Labs said, “Quality culture is improving steadily. The mindset on quality has seen transformation with top management sensitizing the entire hierarchy within the organisations.”

Disease management

With the increasing incidence of non-communicable diseases/chronic diseases (cardiovascular, cancer, chronic respiratory and diabetes), the industry leaders said there needs to be a comprehensive mechanism to manage these diseases. India should move from its reactive health policy approach. The nation is becoming an acute healthcare nation and chronic diseases need to be handled differently. Samir Mehta, Torrent Pharma, executive chairman, said, “Diabetes and cardiovascular diseases are going to be high in the coming years both in India and China. India has also seen the life expectancy going up from 46 years in 1947 to 67 now. To manage chronic diseases, the country should come out with a national task force. Patient care pathways have to be well defined in order to have a comprehensive healthcare system. India has done well in the vaccines.”

Generics segment

Experts pointed out that generics space will see severe completion and pharma companies will experience continued price pressure. China is commoditising generics and India should evolve its own strategy to sustain generics business globally. – Telangana Today