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DCGI introduces guidelines for product traceability in pharma supply chain
Industry News- Aug 16,24
The introduction of these guidelines is particularly timely, as the Indian pharmaceutical industry has come under scrutiny following reports linking spurious cough syrups from India to children's deaths in Gambia, Cameroon, and Uzbekistan.
The Drugs Controller General of India (DCGI), the nation's top drug regulator, has introduced new guidelines to ensure product traceability throughout the pharmaceutical supply chain, addressing the growing challenge of counterfeit and substandard medicines. The guidelines, rooted in good distribution practices, aim to tackle the issue of inadequate documentation across distribution channels, which has made it difficult to trace products effectively.
The introduction of these guidelines is particularly timely, as the Indian pharmaceutical industry has come under scrutiny following reports linking spurious cough syrups from India to children's deaths in Gambia, Cameroon, and Uzbekistan. In a recent meeting of the DCGI's drugs consultative committee, it was decided to incorporate these good distribution practices into the Drugs and Cosmetic Rules, 1945.
These draft guidelines, aligned with World Health Organization (WHO) standards, will be open for public comment for 30 days before they are finalised. They emphasise the importance of maintaining the original quality of pharmaceutical products throughout the distribution chain, involving all parties such as manufacturers, wholesalers, distributors, and logistics providers.
The guidelines highlight the significant threat posed by substandard and spurious products to public health and safety. They call for strict adherence to procedures that ensure a safe, transparent, and secure distribution system, with comprehensive documentation that allows for traceability from the manufacturer to the final point of sale. This documentation includes records of expiry dates, batch numbers, and dispatch details, which are crucial for facilitating product recalls and investigating cases of counterfeit products.
Senior management within each entity involved in the supply chain is tasked with implementing and maintaining an effective quality system, with periodic reviews to ensure compliance. The move is part of a broader effort to protect the pharmaceutical supply chain from the infiltration of spurious products and to enhance the integrity of India's rapidly growing drug manufacturing industry, which is projected to expand to $130 billion by 2030.
(MSN)
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