Indian Pharmaceutical Industry is the third largest in the world in terms of volume. The legal framework concerning the industry is generally under the microscope, from the actual effects of a certain product to the IPR. There are rules and regulations encompassing the intricate relationship between law and science. This sector is now being called the ‘Sunrise sector’ for its expectancy to expand tremendously over the next few years, moreover, it has been one of the most flourishing industries throughout the Covid-19 pandemic.
Though the healthcare system in India has several vulnerabilities, it goes beyond regulation to the matter of funding and the creation and maintenance of infrastructure.
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Right to Health is not a separate fundamental right but a part of the Right to Life under Article 21 of the Constitution of India, thereby a fundamental right guaranteed to every citizen of India. It is concerned with access to medical services required by people in times of need despite their financial restrictions. Furthermore, It’s a part of the Directive Principles of State Policy under Part IV of the Constitution.
Pharmaceutical laws are concerned with the regulation of acts conducted by the pharmaceutical industry like manufacture, sale, distribution, and use of pharma products, research, and studies across the National and International bases.
The Pharmacy Act, of 1948 provides provisions to regulate the profession and practices of pharmacy. It also provides registration guidelines and specific information for the formation and conduct of the Pharmacy Council of India.
The Department of Pharmaceuticals has been created in 2008 to tackle the issue of lack of affordable medicines, therefore it’s entrusted with the formulation and implementation of policies related to drugs, pharmaceuticals, dyestuff, and other intermediaries. The National Pharmaceutical Pricing Authority (NPPA) enforces Drugs (Price Control) Order 1995 and other orders such as recovering overcharged amounts from manufacturers. The Central Drugs Standard Control Organization (CDSCO), developed under the Ministry of Health & Family Welfare, provides regulatory requirements in India such as responsibilities of the states and centre, approval for drugs, and uniformity in enforcing the drugs and cosmetics Act.