Ensuring Pharmaceutical Integrity: The Impact of India's Drugs and Cosmetics Act Relating to Spurious Drugs on Public Health
Battu Vaishnavi
Department of Pharmaceutics, Centre of Excellence in Regulatory Sciences, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, India.
Balamuralidhara V *
Department of Pharmaceutics, Centre of Excellence in Regulatory Sciences, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, India.
Deeksha K S
Department of Pharmaceutics, Centre of Excellence in Regulatory Sciences, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015, India.
*Author to whom correspondence should be addressed.
Abstract
The Drugs and Cosmetics Act, 1940, plays a vital role in regulating drugs and cosmetics in India. It encompasses various chapters, each addressing specific aspects of quality, safety, and effectiveness. Notably, the Act defines spurious drugs explicitly in different contexts, with stringent penalties for violations. These provisions are designed to protect public health by ensuring the authenticity and quality of pharmaceutical and cosmetic products, thus preventing the distribution of counterfeit or adulterated items.
Over the years, the Act has undergone several amendments to adapt to changing needs and advancements in the pharmaceutical and cosmetic industries. These amendments have strengthened the regulatory framework and addressed emerging challenges.
A case study from the Rajasthan High Court in 2012 illustrates the Act's practical application. In this case, an individual was accused of manufacturing and distributing fake life-saving injections. The court's decision to reject bail emphasized the gravity of the accusations and the importance of considering the nature of the offense. The Drugs and Cosmetics Act, 1940, with its amendments, is a cornerstone of pharmaceutical and cosmetic regulation in India, prioritizing public health and product quality.
Keywords: Drugs and cosmetics act, pharmaceutical regulation, spurious drugs, public health, amendments, regulatory framework, drug quality, counterfeit drugs, India, pharmaceutical integrity