Cough syrup linked deaths: need for revised production norms
- June 22, 2023
- Posted by: OptimizeIAS Team
- Category: DPN Topics
No Comments
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)
- PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)
- 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.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/C)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Note: Harmonization is a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products. It helps in safety, efficacy as well as improving market access. |
Cough Syrup incident in Gambia Around 66 children in Gambia died after consuming cough syrup exported from India. Investigation revealed the presence of high amounts of diethylene glycol and another toxic alcohol called ethylene glycol. Both are used industrially and are harmful to human body, consumption of which leads to kidney problems. Following the incident WHO put out a global warning over four India-made cough syrups. |