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Good Distribution Practices For Pharmaceutical Products – Food, Drugs, Healthcare, Life Sciences

India: Good Distribution Practices For Pharmaceutical Products

01 February 2021

Nexdigm Private Limited

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Foreward

While COVID-19 has brought global and national healthcare under scrutiny, the world continues to depend on Indian pharmaceutical and vaccine manufacturers substantially for their supply of medications. The Indian pharmaceutical industry has an important role in promoting local and global health goals. Rightly hailed as the ‘Pharmacy to the World,’ Indian pharma is home to over 3,000 manufacturers and ~10,500 manufacturing units, with domestic annual revenue of USD 20 billion as of 2019. The world’s 3rd largest manufacturer by volume, India’s role in manufacturing affordable medicines, particularly generics, makes the industry critical in the global landscape.

An industry with strong continuing growth prospects, Indian pharma still has considerable room to improve in the area of quality standards for domestic distribution practices. With experts suggesting that the pharmaceutical industry could grow to ~USD 100 billion in size by 2025, there is a clear need for strengthening domestic and global supply standards to unlock such potential.

Good Distribution Practices or ‘GDP’ aim to establish standards to help maintain the quality and integrity of pharma products across the supply chain. As GDP would cater to a wide range of products with different storage requirements and shelf lives, this challenging initiative requires close collaboration between policymakers and the industry. India’s complex Supply Chain, which has limited traceability and a highly localized and fragmented last-mile delivery network, further compounds the challenge.

Effective management of product distribution is globally recognized as a critical issue and receives continuing focus and attention from major stakeholders and regulators. Global regulators have identified and addressed it, with the USFDA, WHO, EU, and PIC/S issuing GDP guidelines in their respective jurisdictions. Overall, these guidelines focus on critical areas like quality management, warehouse management and storage standards, product transportation and tracing, and training and manpower development, among others. India’s pharmaceutical GDP initiative was initiated by the Central Drugs Standard Control Organization (CDSCO) in 2018, with the release of draft guidelines. These now need to be rapidly reviewed and finalized, followed by quick well-governed implementation.

Establishing and abiding by detailed and well-structured GDP would go a long way in solidifying the global aspirations of Indian pharma. Not only can GDP help improve patient health outcomes, but it can also help address reputational, litigation, and financial risks for pharma manufacturers. This includes managing product recalls, reducing counterfeiting, or ensuring compliance with local permissions, among others. The supply chain needs an overhaul and a regulatory impetus can certainly catalyze the change.

As India moves to achieve the goal of ‘One Nation, One Drug,’ the quality gap between export and domestic markets needs to be eliminated. While the initiative requires significant monetary and policy investment, the clear and tangible benefits to stakeholders in the medium to long run certainly justify it.

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