General Principles of Law, History and various Acts related to Drugs and Pharmacy profession

General Principles of Law

The legal system in India is influenced by constitutional provisions. Some general principles that are fundamental to the Indian legal system include:

• 1. Rule of Law: The Constitution of India establishes the supremacy of the rule of law. All individuals, including government officials, are subject to the law.

• 2. Equality before the Law: Article 14 of the Constitution guarantees equality before the law and equal protection of laws to all citizens. It prevents discrimination on grounds of religion, race, caste, sex, or place of birth.

• 3. Presumption of Innocence: The criminal justice system in India operates on the principle that every person is presumed innocent until proven guilty.

• 4. Fait Trial: The right to a fair trial is considered a fundamental right. This includes the right to legal representation, the right to be heard, and the right to present evidence.

• 5. Natural Justice: The principles of natural justice include the right to be heard Administrative actions are expected to adhere to these principles.

• 6. Higher court Decision; The decisions of higher courts are binding on lower courts. It creates a precedent that should be followed in similar cases.

• 7. Judicial Review: The judiciary system reviews the actions of the executive and legislative branches to ensure they are within the constitutional framework.

• 8. Protection of Fundamental Rights: The Constitution of India guarantees certain fundamental rights to its citizens, such as the right to life and personal liberty, freedom of speech and expression, and freedom of religion.

• 9. Separation of Powers: The Indian Constitution establishes a separation of powers among the executive, legislative, and judicial branches of government to prevent abuse of power.

• 10. Public Accountability: Government officials are held accountable for their actions, and transparency in governance is encouraged to ensure public trust.

History and various Acts related to the Drug and Pharmacy profession

History

Ancient Indian society is the oldest civilization in the world. Indian system of medicines declined during Muslim rule. Almost all scientific traditions to treat disease through the Indian system were destroyed by invaders. Arabic or Unani, Tibbi system flourishes during Muslim rule in India. British traders enter into India. They become ruler in India in the second half of the 19th century. They introduced the Allopathic system to treat ruling races suffering from diseases. Slowly it became popular among people at the end of the 19th century. Arabic, Unani, and Tibbi systems faced a decline in their popularity.

Late 19th and Early 20th Century: Drugs were imported from abroad into India. The motto of pharmaceutical industries was to earn profit not to provide service. Pharmaceutical industries abroad started to manufacture substandard and spurious drugs, especially in India. India became the top dumping ground for dumping fake, quack, adulterated, and inferior-quality medicines. Allopathic systems in India were also full of quack unqualified practitioners. There were no administrative controls to stop unhealthy practices and to control the pharmaceutical business.

Indian Medical Gazette published the articles between 1927 and 1929. The abstract of these articles stated “India is land of quack medical practitioners, quack dentists, quack opticians, quack medicine dealers, quack medicines. Most Western countries especially the United Kingdom, the United States of America, etc have strict rules and regulations to control medicine practices. In India, there are no such laws to control substandard activities related to medicines. There are rigorous regulations for strict control over the quality of medicines supplied by manufacturers in other countries. In India, no such laws exist to control imports or manufacturing. and sale of medicines”

At the start of the 20th century, the Council of State passed a resolution on 9th March 1927 regarding pharmaceutical conditions in India. This resolution was to recommend Provincial Government do needful to control the uncontrolled use of medicines and to frame the legislature to regulate quality control of medicines and their sale in India.

Drug Enquiry Committee: The British government of India constitutes a drug inquiry committee on 11th August 1930 under the chairmanship of the late Col. R. N. Chopra. A Drug Enquiry Committee was constituted to find out the availability and use of medicines and to submit recommendations to improve conditions that exist in medical professions.

The Drug Enquiry Committee submitted its report in 1931 after a thorough investigation throughout India. The Drug Enquiry Committee stated the following facts regarding the conditions of the pharmacy profession and the availability of medicines in British India. “No recognized pharmacy professions exist in India. The pharmacy profession in India is represented by compounders whose functions and duties are not well defined. They carry out compounding, dispensing, and selling of medicinal substances. There are no restrictions and regulations to control the handling of drugs and poisons. They do not know the properties and potency of medicinal substances they handle. They work as a laboratory assistant, dressers, operation theatre assistant, anesthetists, physicians, surgeons, etc”. Their educational qualification is very low with almost nil practical training to handle all these specialized practices related to human health and life.”

Their report again stated “There is no availability of basic qualifications for these health workers except Compounder course in Bengal and Chemist Druggist course in Madras. Their ability to read prescriptions in English and write down dictation in English is sufficient to perform all activities stated above.”

Just after the publication of this report, Professor Mahadev Lal Schroff started pharmacy education at Banaras Hindu University in 1932. Then various other universities also introduced pharmaceutical courses. The United Provinces Pharmaceutical Association was organized in 1935. This organization became The Indian Pharmaceutical Association in United India. Journal “The Indian and Eastern Chemist” published in London, “The Pharmaceutical Journals” and “The Chemist and Druggist” supported for better pharmaceutical services in India. Professor Mahadev Lal Schroff published The Indian Journal of Pharmacy in 1939 and organized the All India Pharmaceutical Conference in 1940. Individuals, organizations, and print media played their important roles and slowly pharmaceutical legislations were framed in British India and United Free India.

Acts related to the Drugs and the Pharmacy profession

In India, the drug and pharmacy profession is governed by several acts and regulations that establish the legal framework for the manufacturing, distribution, sale, and use of drugs and pharmaceuticals. The following are some acts related to drugs and the pharmacy profession in India:

• 1. Drugs and Cosmetics Act, 1940:

  • It governs the import, manufacture, distribution, and sale of drugs and cosmetics in India.

  • It establishes the regulatory framework for the licensing and registration of manufacturers, distributors, and sellers of drugs and cosmetics.

  • It Prescribes standards for the quality, safety, and efficacy of drugs and cosmetics.

• 2. Pharmacy Act, 1948:

  • It regulates the pharmacy profession in India.

  • It establishes the Pharmacy Council of India (PCI) and State Pharmacy Councils to regulate pharmacy education and practice.

  • It outlines the qualifications for pharmacists, their registration, and professional conduct.

• 3. Narcotic Drugs and Psychotropic Substances Act, 1985:

  • It regulates the production, manufacture, possession, sale, purchase, transport, warehousing, use, consumption, inter-State, and intra-State trade, import, export, or transshipment of narcotic drugs and psychotropic substances.

  • It aims at preventing the abuse of and illicit traffic in these substances.

• 4. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954:

  • It Prohibits the advertisement of certain drugs and remedies for the treatment of certain diseases and disorders.

  • It aims to prevent misleading advertisements related to the efficacy of drugs.

• 5. Medical Termination of Pregnancy (MTP) Act, 1971:

  • It regulates the termination of pregnancies by registered medical practitioners.

  • It establishes conditions under which pregnancy may be terminated.

• 6. Insecticides Act, 1968:

  • It regulates the import, manufacture, sale, transport, distribution, and use of insecticides to prevent risk to human beings or animals.

  • It enforces the registration of insecticides.

• 7. Poisons Act, 1919:

  • It regulates the import, manufacture, sale, and possession of certain poisons.

  • It aims to prevent the misuse of poisonous substances.

• 8. Indian Pharmacopoeia Commission Act, 2010:

  • It establishes the Indian Pharmacopoeia Commission (IPC) to set drug standards in the country.

  • The IPC publishes the Indian Pharmacopoeia, which serves as a book of standards for drugs.

• 9. Essential Commodities Act, 1955:

  • It empowers the government to control the production, supply, and distribution of essential commodities, including certain drugs, in the interest of the public.

• 10. Consumer Protection Act, 2019:

  • It protects the rights of consumers, including those purchasing pharmaceutical products.

  • It establishes consumer commissions at the district, state, and national levels to address consumer grievances.

• 11. FSSAI (Food Safety and Standards Authority of India) Act and Rules

  • It ensures the safety and quality of food products in India.

• 12. Drugs Price Control Order (DPCO) - 2013.

  • It aims to control and regulate the prices of essential medicines to ensure their affordability and availability.

• 13. Biomedical Waste Management Rules 2016.

  • It aims for proper and environmentally sound management of biomedical waste generated from healthcare facilities.

• 14. Disaster Management Act 2005.

  • It aims to provide for the effective management of disasters, including natural and man-made catastrophes.

Alok Bains