India’s CDSCO to Enhance Quality Oversight for Nutraceuticals

At the Indian Pharmaceutical Alliance’s (IPA) 9th Global Pharmaceutical Quality Summit, held in Mumbai in 2024, India’s Central Drugs Standard Control Organization (CDSCO) Drugs Controller General, Rajeev Raghuvanshi spoke about the efforts to strengthen quality oversight in India. He addressed:

• regulatory non-compliance and quality issues
• capacity building projects in the CDSCO pipeline
• approval timelines in different divisions, and
• potential areas of weakness.

The potential regulatory changes in India’s nutraceutical sector, were discussed at an interview with Karthik Kondepudi from Herbochem, headquartered in Hyderabad, India.

Herbochem is a manufacturer, exporter and supplier of Plant Extracts, Phyto Chemicals, Protein hydrolysate, herb powders which are ingredients in Nutraceuticals, pharmaceuticals, and the cosmetics industry 

Here are the key points:

1. Regulatory Impact:
– The move to CDSCO oversight will bring pharmaceutical-grade standards to nutraceuticals
– Initial challenges include increased operational costs and longer product launch times
– Long-term benefits include improved global competitiveness and quality standards

2. Consumer Trust and Global Competition:
– Stricter regulations will enhance consumer confidence through better safety and efficacy standards
– Indian nutraceuticals can gain better positioning in international markets
– Improved standards may facilitate more international partnerships and export opportunities

3. R&D and Innovation:
– Companies will need to increase R&D investments to meet compliance standards
– This will drive innovation in formulation techniques and extraction processes
– Enhanced focus on scientific capabilities combined with traditional knowledge

4. Challenges for Small Manufacturers:
– Smaller companies will face significant financial pressure from compliance costs
– Operational adjustments include upgrading facilities and training staff
– May lead to industry consolidation or strategic partnerships among smaller players

5. Market Impact:
– Regulatory changes will create a more transparent market
– Expected to improve product accessibility and diversity
– Will ensure that quality-verified products reach consumers

While these regulatory changes present initial challenges, they’re expected to benefit the industry in the long term through improved quality standards, global competitiveness, and consumer trust.

Last updated: December 26th, 2025