India Notifies Updated Good Manufacturing Practices for Drug Makers

January 8, 2024

After recent incidents overseas allegedly linked to poor quality India-made drugs, India’s health ministry has notified enhanced Good Manufacturing Practices (GMP) guidelines to govern quality control and production protocols for domestic pharmaceutical companies.

Need to Align With Global Standards

The move comes after the Union Health Minister directed drug makers to adopt GMP protocols on par with WHO-benchmarked norms as deaths possibly tied to contaminated syrups exported from India were reported in Gambia and Uzbekistan.

Recent Audits

Safety audits of Indian facilities revealed deficiencies around quality checks, validation, contamination risks etc. underscoring the urgency of strengthening compliances.

Two-Tiered Deadlines for Adoption

While big companies with over ₹250 crore turnover must implement the new guidelines within 6 months, relatively smaller firms get a 1-year timeline for upgrades to attain compliance.

Increased Investment Needed

With nearly 10,500 manufacturers countrywide, an estimated 2000 large exporters are already WHO-GMP compliant. But the smaller players will require substantial infrastructure and systems overhaul needing capital, so hoped for more transition time.

Core Areas Addressed

The revised protocols prioritize quality control enforced through better documentation, product testing and reliability of manufacturing procedures enabled via digital systems.

Mandating Recalls Protocol

New provisions also introduce mandatory recalls for companies if products seem defective – a vital protocol for safeguarding consumer well-being previously lacking.

Prospective Assessments and Reviews

Through emphasizing prospective quality assessments and data accuracy, the upgraded GMP reinforces reliability and transparency across production cycles.

Elevating Exporters’ Global Perception

Aligning Indian pharma majors with the most stringent safety and quality benchmarks proactively rather than reactively will boost confidence in their exported formulations besides protecting domestic consumers.

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