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The drug regulators may look at adapting a risk-based approach, focusing on high-risk products while providing fast-track approvals for reputed exporters, to bring in a more balanced approach between international regulatory responsibility and domestic trade interests, says a regulatory technology expert.
The focus should be on enhancing domestic quality standards rather than over-relying on international certifications, NOCs, and licenses, which are often expensive, time-consuming, and difficult to obtain, said Rishi Agrawal, CEO and Co-Founder of Teamlease Regtech, a leading regulatory technology company focusing on compliance solutions.
In order to ensure a balanced approach between international regulatory responsibility and domestic trade interests, the country must ensure quality without creating barriers.
"India, as the 'pharmacy of the world', must uphold global regulatory standards. However, mandating prior approvals could delay shipments, disrupt supply chains, and make Indian pharmaceutical exports less competitive. A risk-based approach, focusing on high-risk products while providing fast-track approvals for reputed exporters, could be a more balanced alternative," said Agarwal.
Micro, small and medium enterprises (MSMEs), already facing rising compliance costs and regulatory complexities, should be supported to meet the compliance standards. Instead of imposing blanket restrictions, the government could provide capacity-building support, subsidised registration assistance, or phased implementation to ensure smaller players are not disproportionately affected.
The industry should be offered with clearer transition timelines, since a sudden policy shift can create uncertainty. A well-structured transition plan, including stakeholder consultations and a grace period for existing contracts, would ensure smoother adaptation without disrupting trade.
To safeguard India's pharmaceutical sector, the focus should be on enhancing domestic quality standards rather than over-relying on international certifications, NOCs, and licenses, which are often expensive, time-consuming, and difficult to obtain.
Agarwal stated that strengthening internal regulatory mechanisms will ensure greater transparency and accountability in manufacturing while preventing delays that could compromise product integrity. Strict compliance must be met through robust reporting mechanisms, frequent batch-level inspections, and randomized testing to detect and eliminate substandard, non-standard, or spurious drugs.
"Severe penalties should be imposed on violators to serve as a deterrent, making non-compliance an unviable option. The cost of poor compliance must be so high that pharmaceutical standards remain uncompromised," he added.
Currently, India fulfills over 60% of the vaccine needs and 40% of the generic drugs in the United States, alongside 25% of the UK’s generic drug requirements. It has around 3,000 companies and over 10,563 industrial units and is expected to grow from $50 billion in 2024 to $450 billion in 2047, he pointed out.
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