Biotechnology Regulatory Affairs and Ethics

Regulatory Affairs, Bioethics, and Biosafety

• Regulatory affairs in bio-business involve regulatory bodies and their regulations, such as FDA, EU, DSIR, AYUSH, and FSSAI.
• The role of regulatory affairs professionals is to ensure compliance with safety and efficacy regulations, protect human health, and ensure safety, efficacy, and quality of drugs.

Goals of Regulatory Affairs

• Protection of human health
• Ensuring safety, efficacy, and quality of drugs
• Ensuring appropriateness and accuracy of product information

Roles of Regulatory Affairs Professionals

• Acting as a liaison with regulatory agencies
• Preparing organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions
• Ensuring adherence and compliance with all applicable cGMP, ICH, GCP, GLP guidelines, regulations, and laws
• Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans
• Advising companies on regulatory aspects and climate that would affect their proposed activities

Work Profile of a Regulatory Affairs Professional

• Filing NDA/ANDA/MAA of drug products with regulatory agencies for getting marketing approval
• Assessing and filing supplements/amendments/variations to the information in NDA/ANDA/MAA with regulatory agencies for prior approval or after implementation
• Filing annual/biannual reports with regulatory agencies
• Reporting any adverse effects that have occurred/may occur due to the use of drug products
• Maintaining complete history of each drug product

Regulatory Bodies

• FDA: ensures that foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe
• BRAI: a proposed regulatory body in India for uses of biotechnology products, including genetically modified organisms (GMOs)
• CDSCO and DCGI: responsible for approvals of preclinical and clinical trials, new drug applications, and importation of drugs from abroad
• GEAC, RDAC, RCGM, IBSC, SBCC, and DLC: additional approvals required for biologics

Department of AYUSH

• Promotes and propagates Indian systems of Medicine and Homoeopathy
• Committed to infusing wisdom of traditional medicine with methodologies of modern science
• Developed a broad institutional framework to carry out its activities
• Coordinates activities relating to conservation, cultivation, marketing, export, and policy-making for the development of medicinal plants

Research Councils

• CCRAS, CCRYN, and CCRH: responsible for sponsored research activities

Standardisation and Testing of Drugs

• Four different Pharmacopoeia Committees are working in preparing official formularies/pharmacopoeias to evolve uniform standards for single drugs as well as compound formulations
• Drug Quality Control Cell deals with matters pertaining to licensing, regulation, and control of drugs and spurious manufacture of Ayurvedic, Unani, and Siddha drugs and other matters

Food Safety and Standards Authority of India (FSSAI)

• Established under Food Safety and Standards Act, 2006
• Lays down science-based standards for articles of food
• Ensures the availability of safe and wholesome food for human consumption
• Framing of Rules, Regulations, Standards, and Guidelines in relation to articles of food

Biosafety and Biosecurity

• Biosafety deals with containing principles, technologies, and practices to prevent unintentional exposure to pathogens and toxins or their accidental release
• Biosecurity has different meanings in different contexts and refers to safeguarding against invasive species, biosafety is part of the first dedicated guidance policy published on laboratory biosecurity

Test your knowledge of regulatory bodies and their regulations in bio business, public education, and ethical concerns of biotechnology research and innovation.