(MENAFN- KNN India)
New Delhi, Aug 12 (KNN) The Drugs Controller General of India (DCGI) has introduced new standard operating procedures and guidelines aimed at improving product traceability across the Pharmaceutical supply chain.
This initiative comes in response to growing concerns over counterfeit and substandard medicines in the market, reported Livemint.
The DCGI's new good-distribution practices seek to address the challenge of ensuring product traceability, which has been hampered by inadequate documentation throughout the distribution network.
These guidelines are designed to help identify the precise point in the supply chain where adulteration or introduction of counterfeit drugs may occur.
This move gains significance as India's pharmaceutical sector faces international scrutiny following allegations linking Indian-made cough syrups to child fatalities in several countries.
The new guidelines, which are aligned with World Health Organisation standards, mandate adherence to good distribution practices for all parties involved in the pharmaceutical supply chain.
They also require the implementation of procedures to ensure a safe, transparent, and secure distribution system.
A key aspect of the guidelines is the requirement for comprehensive documentation to facilitate product traceability and potential recalls.
This includes maintaining detailed records of batch numbers, expiry dates, and distribution channels from manufacturer to end-user.
The guidelines also emphasise the responsibility of senior management in establishing and maintaining effective quality systems within their organizations.
The draft guidelines have been opened for stakeholder feedback for a 30-day period before finalisation. Once implemented, these rules will be integrated into the Drugs and Cosmetic Rules, 1945, as a formal Schedule.
This regulatory update is expected to have a significant impact on India's pharmaceutical industry, which is currently valued at USD 50 billion and projected to reach USD 65 billion by the end of 2024, with further growth to USD130 billion anticipated by 2030.
With approximately 3,000 drug companies and 10,500 manufacturing units, India plays a significant role in the global pharmaceutical market.
These new regulations represent a crucial step in addressing quality concerns and enhancing India's reputation as a reliable pharmaceutical manufacturer and exporter.
By improving supply chain transparency and traceability, the guidelines aim to bolster confidence in Indian pharmaceutical products both domestically and internationally.
(KNN Bureau)
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