Regulatory Focus™ > News Articles > India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

India's CDSCO Finalizes Guideline on Good Distribution Practices for Biologicals

Posted 23 October 2012 | By Alexander Gaffney, RAC

India's Central Drug Standards Control Organization (CDSCO) has finalized and released a new guideline on good distribution practices for biological products manufactured in the country.

Regulators said the guideline, originally released in late September 2012 in draft form, is intended to, "Assist in ensuring the quality and identity of biological products during all aspects of the distribution process." 

Guidelines on Good Distribution Practices for Biological Products would, among other things, place equal responsibility on all supply chain entities to ensure that biological products are maintained in a quality-controlled, secured and adequate environment. The principles of GDP will be required to be upheld from site to sale, wrote regulators.

One of the core components of GDP will also be the establishment, definition and maintenance of a quality control structure complete with specific delegations of authority. These personnel should be adequately trained in product handling, product testing, sanitary procedures and supply chain integrity procedures, wrote CDSCO.

[For Regulatory Focus' previous reporting on this topic, please see, "India's CDSCO Releases New Draft Distribution Guidelines."]

An analysis of the documents shows regulators adopted the draft version of the guideline without making or adopting any changes.

The guideline went into effect as of 8 October 2012.


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