In industrial pharmacy, regulatory authorities are government agencies responsible for overseeing the development, approval, manufacture, and distribution of pharmaceutical products to ensure their safety, efficacy, and quality.
Here are some of the key regulatory bodies in India:
1) Central Drugs Standard Control Organization (CDSCO)
Responsibilities: Drug approval, clinical trials, setting drug standards, quality control, and regulatory oversight for pharmaceuticals and medical devices.
Affiliation: Under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
2) State Drug Control Departments of Regulatory Authorities
Responsibilities: Oversight of manufacturing, sales, and distribution of pharmaceuticals within their respective states.
Affiliation: Operate at the state level, complementing the role of CDSCO.
3) Indian Pharmacopoeia Commission (IPC)
Responsibilities: Setting standards for drugs listed in the Indian Pharmacopoeia.
Affiliation: Independent regulatory body.
4) Other Regulatory Bodies
Responsibilities:
Ministry of AYUSH: Oversees regulation of traditional and alternative medicines in India.
Department of Biotechnology (DBT): Involved in the regulatory framework for biotech products and research.
Indian Council of Medical Research (ICMR): Plays a role in clinical research and regulatory policy, particularly for medical research and trials.
Affiliation:
Each operates under specific governmental departments or ministries based on their specialized focus area.
These regulatory authorities collectively ensure that pharmaceutical products are safe, effective, and meet quality standards through a coordinated system of oversight and regulation