Indian Pharmacopoeia Commission Joins PDG | 13 Oct 2023
Why in News?
The Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG), a pivotal move to enhance global pharmaceutical standards, regulatory compliance, and international recognition of Indian pharmaceutical products.
- IPC was the only Pharmacopoeia body in the world to be selected for the pilot phase initiated in September 2022. After a year-long pilot phase, IPC's inclusion as a permanent PDG member was confirmed in September 2023.
What is the Pharmacopoeial Discussion Group (PDG)?
- The PDG is an international forum that aims to harmonize global pharmacopoeial standards to reduce the burden on manufacturers and ensure consistent quality.
- The PDG was established in 1989 by the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP), and the US Pharmacopeia (USP).
- In 2001, the World Health Organization (WHO) joined as an observer.
How Will IPC's Membership in the PDG Benefit India?
- IPC's standards will gain international recognition, potentially boosting the acceptance of Indian pharmaceutical products globally. It will position IPC as a forward-looking body that sets drug quality standards in line with global benchmarks.
- IPC can collaborate and harmonize standards with other major regulatory bodies, ensuring global pharmaceutical quality and safety.
- IPC can align its processes with global standards, making it easier for Indian pharmaceutical companies to comply with international regulations.
- Membership in PDG will facilitate increased exports of Indian pharmaceutical products to member countries, reducing trade barriers.
Indian Pharmacopoeia Commission (IPC)
- IPC is an Autonomous Institution of the Ministry of Health and Family Welfare.
- IPC was created to set standards for drugs in India. Its basic function is to regularly update the standards of drugs commonly required for the treatment of diseases prevailing in this region.
- It publishes official documents for improving the Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP).
- It further promotes the rational use of generic medicines by publishing the National Formulary of India.
- IP prescribes standards for the identity, purity and strength of drugs essentially required from the health care perspective of human beings and animals.
- IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP.