Incorporate Good Distribution Practices guidelines as separate Schedule in Drugs and Cosmetics Rules, 1945: DTAB recommendation

New Delhi: In a move to provide quality drugs to patients, the Drugs Technical Advisory Board (DTAB) has recently recommended to include provisions on Good Distribution Practices (GDP) of Pharmaceutical Products in the Drugs and Cosmetics Rules, 1945 to incorporate GDP guidelines as a separate Schedule in the said rule.

The DTAB was apprised that the objective of the quality control over drugs is to ensure that the patients get quality drugs. For this purpose, it is necessary to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process which includes procurement, purchasing, storage, distribution, transportation, and associated documentation/ record-keeping practices. Each activity in the distribution system is required to be carried out in accordance with the principles of Good Distribution Practices (GDP).

The involvement of unauthorized entities in the distribution and sale of pharmaceutical products is a matter of concern as it leads to an introduction of spurious drugs in the supply chain. It is the responsibility of all parties involved in the distribution of pharmaceutical products to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process.

The said matter was deliberated earlier in the Drugs Consultative Committee meeting wherein the report of the sub-committee constituted for the preparation of Guidelines on GDP of Pharmaceutical Products was considered. The matter was also deliberated in the meeting of DCC and the DCC suggested taking necessary provisions to impart legal sanctity to the suggested guidelines as a Schedule to the Drugs and Cosmetics Rules, 1945 to penalize the offenders.

Subsequently, a notice was issued to all State/UT Drugs Controllers and stakeholders inviting comments/ suggestions on the draft guidelines. Comments/ suggestions have been received and are compiled.

DTAB in its meeting deliberated on the issue and agreed to incorporate GDP guidelines as a separate Schedule in the Drugs and Cosmetics Rules, 1945.

Further, this issue of incorporation of GDP guidelines as a separate Schedule was deliberated in the DCC meeting and it is recommended to make necessary provisions for Good Distribution Practice under the Drugs and Cosmetics Rules, 1945.

DTAB deliberated the matter and recommended to amend the Drugs & Cosmetics Rules, 1945 for provisions for Good Distribution Practices (GDP) of pharmaceutical products.

Also Read: Grant of Manufacturing License for Drugs: DTAB recommends amendment of Drugs and Cosmetics Rules, 1945