Source: LiveMint
New Delhi: With the Indian pharmaceutical industry increasingly coming under the scanner globally, the Central Drugs Standard Control Organisation (CDSCO) is conducting a major exercise for improving the quality, safety and efficacy of biological products.
The apex drug regulator has come up with the latest guidelines on biological products such as vaccines, biological, and recombinant DNA products that are to be in tune with international guidelines including that of the World Health Organization (WHO) and regulators in other countries.
As part of the exercise, India’s national regulator for cosmetics, pharmaceuticals and medical devices has circulated a draft document reviewed by Mint for consultation. The CDSCO has sought comments or objections from stakeholders by the middle of April.
The latest norms have classified products that need to adhere to the new guidelines such as biological products containing substances that have been produced by using living cells or organisms such as vaccines, genetically engineered DNA products, biotherapeutic products that are off patents, cell and gene therapy products, blood and blood products.
“This would include an emphasis on applying a science-based and risk-based approach to the quality, safety and efficacy assessment of the biological products,” the new guidelines state. The guidelines also specify rules for labelling the products. The products should be classified in categories such as supplements (safety and efficacy), notifiable changes (safety and efficacy) i.e. risk or harm management change, notifiable changes (safety and efficacy) that are not risk or harm management changes, and annual notifications (safety and efficacy).
“Changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the biological product as these factors may relate to the safety and/or efficacy of the product,” the guidelines stated.
The new guidelines also have points to be mentioned on product packages which includes—product monograph such as title page, storage and stability, dosage forms, composition, packaging and revised product labelling information, information on the changed nomenclature of the drug substance, and evidence that the changed name for the drug substance is recognized.
India had a moment of worldwide humiliation in 2022 when Gambia and Uzbekistan released reports on infant deaths in their nations tied to cough syrups that were made in India. Following the event, the Union health ministry and CDSCO stepped up their efforts to monitor drug products and conduct quality checks.
