India is taking significant steps to combat the proliferation of counterfeit medicines by proposing mandatory registration for manufacturers and suppliers of printed pharmaceutical packaging materials. This initiative aims to enhance the traceability and authenticity of pharmaceutical products, thereby safeguarding public health and reinforcing the credibility of India's $50 billion pharmaceutical industry, which supplies 20% of global generic medicines and 60% of vaccines to over 200 countries.
The Central Drugs Standard Control Organisation (CDSCO) has initiated internal discussions to amend the Drugs Rules, 1945, to include an online registration framework for entities involved in the production and supply of printed pharmaceutical packaging materials. This move follows investigations that uncovered the diversion and misuse of genuine packaging materials in the manufacturing and distribution of counterfeit drugs, including products like Semaglutide and anti-rabies vaccines.
Under the proposed framework, manufacturers and suppliers would be required to obtain a Packaging Registration Certificate through a centralized online portal, receiving a unique Packaging Registration Number. This number would be printed on all pharmaceutical packaging materials, facilitating traceability and accountability. Registered entities would also be mandated to maintain comprehensive records of artworks, customer orders, production, supplies, purchaser credentials, and the disposal or destruction of excess or obsolete packaging materials. Additionally, packaging materials could only be supplied to licensed drug manufacturers after verification, and registered premises would be subject to inspections by regulatory authorities.
Industry stakeholders have expressed mixed reactions to the proposal. While some acknowledge the intent to strengthen the pharmaceutical supply chain's integrity, they also highlight the challenges in implementing such a framework. The packaging industry, which has not traditionally been under direct regulatory oversight, may find the new requirements complex and potentially burdensome. Moreover, there is concern that illegal operations operating outside the formal framework could continue to bypass licensing requirements, potentially undermining the effectiveness of the proposed regulations.
Despite these challenges, the initiative represents a significant shift in regulatory oversight, aiming to close existing gaps in the pharmaceutical packaging supply chain. By bringing manufacturers and suppliers of printed pharmaceutical packaging materials under formal registration, the government seeks to enhance the traceability and authenticity of pharmaceutical products, thereby protecting public health and maintaining the global reputation of India's pharmaceutical industry.