Good Distribution Practices in the Pharma Supply Chain - Focus on India

In January 2013, The Central Drugs Standard Control Organization (CDSCO) of India, the country's Authority for Medicinal Product, published a draft Guidelines on Good Distribution Practices for Pharmaceutical Products for public opinion.

The objective of these guidelines is to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to procurement, purchasing, storage, distribution, transportation, documentation and record-keeping practices.

The draft guidance does not yet have a date by which it will become effective.

The Indian pharmaceutical market remains attractive and is expected to grow to US$ 55 billion by 2020 according to the McKinsey & Company report titled " India Pharma 2020: Propelling access and acceptance realising true potential".
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Although India is one of the most significant emerging markets, there are challenges around product quality and regulatory complexity. The new guidelines will have a positive impact on the SME industry in India.

The pharmaceutical distribution system in India is undergoing a paradigm shift and we will continue to see improvements, through compliance with the latest standards and the implementation of the latest technologies for supply chain management.

In an interview with Cold Chain IQ, Bhusan Mohapatra, Head-Commercial Indian Immunologicals, noted that the predicted growth in the Indian vaccine market indicates a lot of opportunities for those involved in the cold chain, from the manufacturer to logistics service provider, the technology provider to trace & track and related software provider.

To view or download the draft guidance document, click here