Proposed guidelines from Indian health officials aim to bolster the traceability of medicines throughout the supply chain, addressing concerns over substandard and counterfeit drugs. This initiative follows discussions by a committee led by the Drugs Controller General of India (DCGI), focusing on the need for stricter regulations on drug storage during transit.
The draft rules call for a comprehensive system where each packaging stage includes 2D barcodes alongside legible text detailing essential information such as the unique product code (GTIN), batch number, expiry date, manufacturing date, and serial number. This initiative is designed to enhance the ability to track medicines from their origin to end-users, effectively reducing the risk of spurious products entering the market.
Currently, guidelines for storage during transportation are not mandatory, leading to issues around the quality of medicines. Officials expressed concern over reports that hospital medicines, marked “not for retail sale,” have been mixed with regular pharmacy stock, raising alarms over expired or damaged products.
During a recent meeting of the Drug Consultative Committee (DCC), the need for improved drug storage practices was emphasized. “Current guidelines aren’t mandatory, which means drug manufacturers aren’t consistently ensuring proper storage conditions until the products reach wholesale and retail levels,” noted an anonymous official. To address these challenges, the draft guidelines align with updated World Health Organization (WHO) standards, although they will require further discussion with stakeholders before implementation.
The proposed rules also advocate for Good Storage Distribution Practices (GSDP) to ensure the quality, safety, and efficacy of medicines throughout their journey from manufacturer to consumer. Medicines are vulnerable to degradation due to improper handling, exposure to extreme temperatures, and other factors, underscoring the necessity of robust distribution practices to combat counterfeit drugs and facilitate tracking.
The current lack of mandatory adherence to these guidelines underscores the urgent need for reform. The intention is to enshrine these practices in the Drugs Rule of 1945, thereby creating a legal obligation for manufacturers, distributors, and retailers alike to ensure the integrity of the pharmaceutical supply chain. A draft notification will be issued once the guidelines are finalized.
India’s pharmaceutical market, valued at approximately $50 billion, is the third-largest globally by volume and fourteenth by value. The nation leads in the supply of generic drugs, contributing to around 20% of the global market, with approximately 60,000 generic drugs across various therapeutic categories.
Rajiv Singhal, General Secretary of the All India Organization of Chemists and Druggists (AIOCD), emphasized the collective responsibility of all parties involved in medicine distribution. “Wholesalers and distributors need to report any suspicious or counterfeit drugs. Pharmacies should ensure proper storage, regularly check quality and expiry dates, and maintain transparent records,” Singhal stated.
Manufacturers have largely welcomed the initiative for mandatory 2D barcoding and traceability measures. Nikkhil K. Masurkar, CEO of Entod Pharmaceuticals, highlighted the significance of this step in addressing issues such as counterfeiting and ensuring accountability throughout the supply chain. “The long-term benefits in patient safety and quality assurance far outweigh any implementation challenges,” Masurkar affirmed.
The proposed changes reflect a growing commitment to enhancing public health and safety in India’s vast pharmaceutical landscape, reinforcing the industry’s reputation both domestically and internationally.
Original Source: https://www.livemint.com/news/india-drugs-delivery-rules-who-barcoding-traceability-spurious-medicines-ent-dermatology-11751973356612.html
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Publish Date: 2025-07-09 06:00:00
