In response to increased scrutiny of India’s pharmaceutical sector on a global scale, the Central Drugs Standard Control Organisation (CDSCO) is taking significant steps to enhance the quality, safety, and efficacy of biological products. The regulatory body has introduced new guidelines for biological products, including vaccines, biological and recombinant DNA products, aligning with international standards such as those of the World Health Organization (WHO) and other international regulators.
The CDSCO’s initiative involves disseminating a draft document for feedback, inviting comments or objections from stakeholders by mid-April. These updated guidelines categorize products that must comply, encompassing those derived from living cells or organisms, such as vaccines, genetically engineered DNA products, biotherapeutic products that are off patents, cell and gene therapy products, and blood and blood products.
A key focus of the guidelines is the adoption of a science-based and risk-based approach to assess the quality, safety, and efficacy of biological products. They also outline specific rules for product labeling, differentiating between supplements (safety and efficacy), notifiable changes (safety and efficacy) for risk or harm management, notifiable changes that do not involve risk or harm management, and annual notifications (safety and efficacy).
Furthermore, the guidelines detail the requirements for product packaging, including the need for a product monograph, storage and stability information, dosage forms, composition, packaging, revised product labeling information, changes in the nomenclature of the drug substance, and evidence that the new name for the drug substance is recognized.
This move comes in the wake of incidents that cast a shadow over India’s pharmaceutical exports, such as the unfortunate reports of infant deaths in Gambia and Uzbekistan linked to cough syrups manufactured in India. These events prompted the Union health ministry and CDSCO to intensify their monitoring and quality assurance processes for drug products.