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Syllabus of Unit 5 :-

  1. Pharmaceutical Legislations - A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee.
  2. Code of Pharmaceutical ethics Definition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath
  3. Medical Termination of Pregnancy Act
  4. Right to Information Act
  5. Introduction to Intellectual Property Rights (IPR)

Summary of Pharmaceutical Legislations

The role of pharmaceuticals has become more prominent on international agendas as health indicators are increasingly linked with a country’s successful development. In addition, the legal and economic issues that surround pharmaceuticals became more complex and politicized due to the rise in global trade.

Why pharmaceutical laws and regulations are necessary
The use of ineffective, poor-quality, or harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines, and sometimes death. It also undermines confidence in health systems, health professionals, pharmaceutical manufacturers, and distributors. To protect public health, governments must approve comprehensive laws and regulations and to determine effective national regulatory authorities to make sure that the manufacture, trade, and use of medicines are regulated appropriately which the public has access to accurate information on medicines.

Differences between pharmaceutical laws, regulations, and guidelines
Laws today are usually written in fairly general terms to meet present and possibly future needs. Laws usually have language that allows the govt. to issue regulations based on the law. Passing new laws may require a lengthy process, with the country’s subdivision giving final approval. Regulations will be passed earlier and easily than laws, sometimes requiring, as an example, only the approval of one executive on the recommendation of experts. they will even be altered more easily. After approval, a regulation has the identical power because the law itself. Guidelines, which don't carry the force of law, will be more easily modified and updated and offer informal information on what the government’s thinking is regarding the most effective thanks to implement regulations. Following guidelines will help avoid misinterpretation of and facilitate compliance with laws and regulations.