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

June 5, 2023

India is poised to strengthen the quality of its medical products and improve market access by joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This decision comes in response to incidents such as the tragic deaths of 66 children in Gambia, which were linked to toxic Indian-made cough syrups, as well as market access challenges faced by Indian medical products in quality-conscious regions like the UAE and Gulf Cooperation Council. Joining PIC/S will enable India to adopt global standards and pave the way for enhanced cooperation and regulatory practices among countries.

Improving Medical Product Quality and Industry Standards

Under PIC/S, India’s industry, particularly micro, small, and medium enterprises, will be required to adopt global standards, specifically focusing on good manufacturing practices. This step will not only help avert tragedies similar to the Gambia incident but also 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.

Resolving Market Barriers

Certain countries, including the UAE, Gulf Cooperation Council, and other advanced economies, employ reference prices from developed markets to set their own prices. This approach inadvertently acts as a barrier for affordable Indian drugs, despite their 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.

The Role of PIC/S

The PIC/S serves as a platform for harmonizing, educating, and updating aspects related to Good Manufacturing Practice among member countries. Additionally, it plays a pivotal role in fostering relationships and coordination between regulatory authorities and governments. By participating in PIC/S, India will align its manufacturing protocols and quality control measures with international standards, ensuring uniformity and compliance across member countries.

Global Collaboration and Membership

PIC/S boasts a prominent membership base that includes countries like the United States, the United Kingdom, Switzerland, Japan, Germany, France, and others. This collaboration allows participating countries to share best practices, exchange knowledge, and collectively enhance the quality and safety of medical products. India’s membership in PIC/S will strengthen its ties with these nations, leading to a broader exchange of expertise and ensuring the country remains at the forefront of international healthcare standards.

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