REGULATORY REQUIREMENTS FOR THE APPROVAL OF ANTICANCER DRUGS AS PER CDSCO IN INDIA COMPARISON WITH AUSTRALIA

Dr. Ashok Kumar P.*, Pallavi J., Punya K. S., Rakshitha B. R., Priyanka M., Sharanya J.

ABSTRACT

In India, cancer is a significant and growing public health concern, with the number of new cases projected to rise substantially in the coming years. The country's pharmaceutical industry mainly focused on developing affordable generic drugs which includes a range of chemotherapeutic drugs and targeted treatments. This has been an important technique for increasing access to vital cancer treatments for a large population. The Indian anti-cancer drug market is experiencing rapid growth, due to increasing prevalence of cancer, enhancing government programs to lower drug costs and healthcare infrastructure. The Central Drug Standard Control Organization (CDSCO) is the major regulator of medications, particularly anticancer therapies. The CDSCO is in charge of approving new drugs and clinical studies as per the Drugs and Cosmetics Act and the New Drugs and Clinical study Rules 2019.[1] In Australia, cancer is still the biggest reason to death where its survival rates have increased to around 71%. The nation's approach to treatment is shifting from traditional chemotherapy to targeted and personalized therapies, including advanced immunotherapies and hormonal treatments. The "Pharmaceutical Benefits Scheme" (PBS) frequently provides incentives for the availability of specific pharmaceuticals, hence boosting patient access. The Therapeutic Goods Administration (TGA) is Australia's regulating body. TGA thoroughly evaluates novel anticancer medications for safety, quality, and efficacy before they are listed on the ‘Australian Register of Therapeutic Goods’ (ARTG).[2]

Keywords: India, CDSCO, TGA, Anticancer, Australia, ARTG.