The Drugs Controller General of India (DCGI) has rolled out new standard operating procedures and guidelines designed to enhance product traceability within the pharmaceutical supply chain. The move addresses growing worries about counterfeit and substandard medicines.
The updated good distribution practices aim to tackle the issue of product traceability, which has been hindered by insufficient documentation across the distribution network. The new guidelines will help pinpoint where counterfeit or adulterated drugs might enter the supply chain.
The development is particularly important as India’s pharmaceutical industry faces international scrutiny following reports linking Indian made cough syrups to child fatalities abroad. The guidelines, which align with World Health Organisation standards, require all stakeholders in the pharmaceutical supply chain to adhere to good distribution practices.
The new rules also mandate the implementation of procedures to create a safe, transparent, and secure distribution system. A central feature of the guidelines is the requirement for detailed documentation to ensure product traceability and enable effective recalls. This includes recording batch numbers, expiry dates, and distribution routes from the manufacturer to the end-user.
Additionally, the guidelines emphasize the role of senior management in establishing and maintaining robust quality systems within their organizations. The draft guidelines are open for stakeholder feedback for thirty days before they are finalized. Once adopted, the rules will be incorporated into the Drugs and Cosmetic Rules, 1945, as an official schedule.
The regulatory update is poised to significantly impact India’s pharmaceutical sector, valued at $50 billion and expected to grow to 465 billion by the end of 2024, with projections reaching $130 billion by 2030. With around 3,000 drug companies and 10,500 manufacturing units, India is a key player in the global pharmaceutical market.
The new regulations represent a critical step towards addressing quality concerns and enhancing India’s reputation as a trustworthy pharmaceutical manufacturer and exporter. As reported by knnindia.co.in, by improving transparency and traceability in the supply chain, the guidelines aim to strengthen confidence in Indian pharmaceutical products both domestically and globally.
