CDSCO proposes norms to improve biologics standards
The Central Drugs Standard Control Organisation has initiated a major initiative to enhance the standards of biological products amid mounting global scrutiny on the Indian pharmaceutical industry.
The apex drug regulator has come up with new guidelines seeking to improve the quality, safety, and efficacy of vaccines, biologicals, recombinants, and DNA products. The guidelines align with international standards, including those set by World Health Organization (WHO) and regulatory bodies of other countries. As part of the initiative, the regulator for cosmetics, pharmaceuticals, and medical devices circulated a draft, reviewed by Mint, for consultation. The CDSCO has invited stakeholders to comment or raise objections by mid-April. CDSCO has classified products under the new guidelines for biological products derived from living cells or organisms like vaccines, genetically engineered DNA products, off-patent bio-therapeutic products, cell and gene therapy products and blood and blood products.
"It will include an emphasis on applying a science-based and risk-based approach to the quality, safety and efficacy assessment of biological products," it added. The guidelines outline regulations for labelling products and classifying them into different categories, such as supplements (safety and efficacy), changes related to risk or harm management, or unrelated to risk or harm management, and annual notifications regarding safety and efficacy.
"Changes that have the minimal potential to have adverse effect on the identity, strength, quality, purity, or potency of the biological product as these factors may relate to the safety or efficacy of a product," it said.
The CDSCO also mandated requirements for information to be displayed on product packages such as the product monograph (including storage, title page and stability details, packaging, composition, dosage form and updated labelling information), besides details on any change in the drug substance nomenclature, and evidence of recognition for the updated drug substance name.
India faced global embarrassment when In 2022 Gambia and Uzbekistan reported infant deaths linked to cough syrups manufactured in India.
In response, the Union health ministry and CDSCO intensified efforts to monitor drug products and implement quality checks.
The CDSCO also mandated requirements for information to be displayed on product packages