Cough syrup linked deaths: need for revised production norms

Cough syrup linked deaths: need for revised production norms

Subject : Schemes

Key points:

• Pharma industry is demanding that global level production norms may urgently be brought into practice. The specific demand is for Schedule M norms to be aligned with:
  • PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)
    • Pharma MSME’s, will be required to adopt global standards, specifically focusing on good manufacturing practices (GMP).
    • Will facilitate market access in advanced economies. By aligning with international norms, India’s medical product quality will be enhanced, providing assurance to consumers and regulators.
  • ICH (International Council for Harmonisation of technical requirements for pharmaceuticals)
• Significance:
  • India is a leading supplier of drugs all over the world.Even US has significant generic and biosimilar drug supply from India.
  • UAE, Gulf Cooperation Council, and other advanced economies, employ reference prices from developed markets to set their own prices. Because of this Indian medicine are left out even if of superior quality.
  • By becoming a member of PIC/S, India’s prices will also be considered for referencing, allowing the country to overcome these market barriers and gain better access to these regions.
  • PIC/S will be a platform for harmonizing, educating, and updating aspects related to Good Manufacturing Practice among member countries. It also helps in coordination between regulatory authorities and governments.