Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

India has decided to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). With India’s decision to join the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the quality of medical products is expected to improve in the country. In this article, you can learn what the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are all about and also how membership in it will benefit India. This topic is significant for the IAS exam health and polity segments.

Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments.

• The PIC (Pharmaceutical Inspection Convention) was founded by the European Free Trade Association (EFTA) in 1970.
• The Pharmaceutical Inspection Co-operation Scheme was started in 1995. 
• PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S.
• These are between countries and pharmaceutical inspection authorities. 
• The primary objective of PIC/S is to establish and maintain Good Manufacturing Practices (GMP) for pharmaceutical products, which involves setting standards and guidelines for manufacturing, quality control, and regulatory oversight.
• These are designed to promote cooperation and harmonization in the field of pharmaceutical inspections.

Benefits of Joining PIC/S

India’s decision to join PIC/S reflects its commitment with regards to improving the quality of medical products, enabling it to adopt global standards, making imports competitive and international cooperation.

• Enhancing Good Manufacturing Practices (GMP) and Regulatory Cooperation:
  • This decision is in line with the government’s efforts to enhance regulatory cooperation and improve the quality of medical products in the country.
• Enable adoption of global standards:
  • The decision to join PIC/S will enable the Indian medical industry to be in harmony with global standards and practices.
• Addressing Market Access Challenges and improving exports:
  • India’s entry into PIC/S is motivated by the market access challenges faced by Indian medical products in quality-conscious regions such as the UAE and the Gulf Cooperation Council. The price mechanism in the Gulf nations is tilted towards higher prices due to the absence of India and China, where prices are comparatively lower. 
  • This situation acts as a barrier for Indian exporters of affordable medicines. 
  • PIC/S will help overcome such barriers and promote cooperation among regulatory authorities and governments.
• Preventing Tragedies and Ensuring Patient Safety: The tragic deaths of 66 children in the Gambia due to toxic Indian-made cough syrups highlight the importance of quality control in the pharmaceutical industry. 
• Promoting Affordable Medicines and International Cooperation: India’s participation in PIC/S is expected to facilitate market access in advanced economies and promote affordable medicines. By aligning its prices with global referencing mechanisms, India aims to eliminate barriers that hinder the export of affordable drugs. 

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