CBI arrests 5 for taking bribe to exempt Biocon drug from trial

CBI arrests 5 for taking bribe to exempt Biocon drug from trial

Subject: Polity

Section: National Organisation

The Central Bureau of Investigation (CBI) has arrested a Joint Drug Controller (JDC) of the Central Drugs Standard Control Organisation (CDSCO) on charges of accepting a ₹4 lakh bribe from biopharmaceutical company, Biocon Biologics, for waiving off the third phase trial of Insulin Aspart Injection.

Aspart 

• The originator of Aspart, Novo Nordisk, promoted this insulin as an innovative product that enters the bloodstream in about 2.5 minutes to help control blood sugar at meal times.
• Novo Nordisk’s insulin injection Aspart has been available in India under the brand name Fiasp and Novorapid within the price range of Rs 678 to Rs 3,872.
• Bio-similar drugs are known for potentially reducing the price of medicines.
• Biocon, in February 2021, had announced its own bio-similar insulin Aspart named ‘Kixelle’, which had received marketing authorisation approval from the European Commission.

Bio-Similar

• A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company.
• Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires.
• Unlike generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes.
• Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.

CDSCO

• CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
• The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
• CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
• Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.
• Drug Controller General of India within CDSCO is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera