Export NOCs for Unapproved Drugs Made Simple
- Old System
- NOC was an application process for exporters for every order, depending on the customer and quantity.
- New System
- A Blanket NOC will be granted on the basis of one year of export history.
- NOC is issued product and country specific and does not tie itself to a single importer.
- The number of NOCs granted will reduce from ~15,000 to 5,000 in a year to lessen the regulatory burden on exporters.
- Companies are supposed to provide customer details and regulatory proof only once every year.
Impact: With reduced bureaucracy, the export becomes fast and cheap for Indian pharma companies.
New Guidelines for Biosimilars, Cell, and Gene Therapy
- Biosimilars
- New guidelines will replace the ones made in 2018, putting India in line with global marking.
- Cell & Gene Therapy
- India is coming up with its first regulatory framework by CDSCO, DBT, and ICMR.
- All of this is aimed towards providing clarity and streamlining of approvals for companies.
Impact: Greater regulatory clarity enabling innovation in biotech emerging sectors.
Strengthening Regulatory Oversight and Digital Integration
- Increased Inspections
- 905 inspections over two years have ensured compliances post approvals.
- Enhanced inspectorial glare after the Aveo case, a recent regulatory infringement incident.
- Digital Regulatory Platform
- The ₹100 crore project intends to synergize all regulatory stakeholders (state regulators, custom, GST, manufacturer).
- It intends to map the supply chain from approval to sale, ensuring transparency.
- It would be up and running in about two years.
Impact: Stronger oversight reduced compliance risks and increased co ordination.
Pharma on the Rise, Hiking Exports but With Challenges
- Indian Pharma exports grew by 9%, nearly double the global growth rate, as per McKinsey.
- Challenges
- Emerging regulatory trends from India and abroad will disrupt growth.
- Increasing regulatory scrutiny in low and middle income countries (LMICs).
Impact: Growth prospects are bright, but Indian firms must adapt to a very fast changing regulatory environment.
The new and simplified process of NOCs will help exports get done in record time. The new guidelines for biosimilars and cell therapy express India’s interest in aligning with global standards. Strong regulatory oversight integrated inspections with digital methods. Pharma exports are rapidly growing, though companies must contend with regulatory roadblocks.
