CDSCO commitee warns against repacking of Active Pharmaceutical Ingredients into smaller packs by Wholesalers

New Delhi : Taking into consideration, the proposal on measures need to be taken to address the issue of repacking of Active Pharmaceutical Ingredients into smaller packs by wholesalers for sale, the DCC committee of the CDSCO reiterated that the same cannot be allowed to protect the integrity and quality of the products

Active Pharmaceutical Ingredients (Bulk drugs) can be manufactured and sold directly to the formulator or through the wholesaler in accordance with the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under.

It has been observed that in some cases the wholesalers repack the Active Pharmaceutical Ingredients into smaller packs and sale the same to the formulators for manufacturing the finished formulation.

The matter was recently brought up before the DCC committee of the CDSCO.

After detailed deliberation, DCC recommended that repacking of Active Pharmaceutical Ingredients by wholesaler is as such not allowed under the Drugs and Cosmetics Rules, 1945 and it has a potential for breach of integrity and quality of the product.

On the issue of measures that need to be taken to address the issue of repacking of Active Pharmaceutical Ingredients into smaller packs by wholesalers for sale, the committee further noted

Therefore, it was opined that the authorities shall take the information from licensee in their jurisdiction about such activities by issuing letters/notices within 15 days and this compiled information along with executive summary shall be submitted to CDSCO within next 15 days i.e., 30 days after issue of the Notices and then hold national level stakeholders consultation with the representatives/ associations of these licensees by involving the states where such activities are happening, prominently to decide further course of action in consultative manner by understanding the views of stakeholders and spreading the awareness about the provisions of the Rules .