DCC Approves Proposal to Include GDP in Drugs Regulation

Drugs Consultative Committee (DCC) has also sanctioned a proposal to amend the Drugs Rules, 1945, with the inclusion of Good Distribution Practices (GDP) guidelines as a standalone schedule. The action is in line with comprehensive stakeholder consultations and is a move towards giving India's pharmaceutical supply chain legal strength.

The initial proposal in January of 2024 and then the second proposal in June of 2024 were to align the regulation in India with the new Technical Report Series (WHO TRS) of the World Health Organization. The DCC stressed enforceability under law of GDP for the appropriate storage and distribution of drug products from the manufacturer to the retailer.

Earlier, the DCC had postponed action on the proposal in light of consultation with members of industry. On such consultation, the industry put forth issues, which were discussed and are now acted upon by the committee by way of granting clearance to proceed in order to insert GDP into the schedule after amending the Drugs Rules. The minutes of the committee reveal that the decision has been taken after "detailed deliberation" of the feedback received.

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The need for actionable GDP guidelines is also echoed in the recommendations in the first half of this year by the Parliamentary Standing Committee on Chemicals and Fertilisers. The committee called for strong legal action by the Department of Pharmaceuticals to stem the flood of spurious and substandard drugs.

Before this, the Central Drugs Standard Control Organisation (CDSCO) had prepared GDP guidelines in 2018 and released them for stakeholder comments. Here, the DCC observed that voluntary compliance was not occurring, specifically on storage conditions during drug transport.

The new regulations should ensure improved drug quality control and responsibility throughout the chain of drug distribution.