This article on ‘Pharmaceutical Laws in India: All you need to know‘ was written by Ankita Kumari, an intern at Legal Upanishad.
Pharmaceutical is accountable for the discovery, development, removal, secure and efficient use, and regulation of pharmaceuticals and medications at their best use. Pharmaceuticals are the bridge between the Chemistry of the drugs and medical practice. Command in medications along with working mechanisms, health consequences, combinations, and toxicity are prerequisites for practicing pharmacy.
India has a flourishing pharmaceutical and healthcare industry. Enabling the pharmaceutical industry in India, and to take a leadership role in the international market, and ensuring the widespread supply of high-quality, affordable drugs for consumer use, the legislation plays a vital role in that. Therefore, this blooming potential needs to be equipped with laws, thereby, from establishing the councils of pharmacy to regulating the profession of pharmacy.
This article will assist you to understand what pharmaceutical means and what the laws and regulations that regulate the pharmaceutical industries in India.
What do you mean by pharmaceutical?
Pharmaceuticals are the material used to restore, rectify, or improve natural processes as well as diagnose, provide better cures, and thereby reduction of the risk of any disease altogether. For example, sleeping peels, Cyrus, or any other medicine works on the same principles. Pharmaceuticals are often categorized by chemical family, pharmacological activity, and therapeutic application.
What difference between pharmacists and pharmaceutical scientists?
A medical professional who has received special training to be an expert in medications is a pharmacist. Their role holds important responsibilities in informing individuals about the dangers of taking medications and teaching them how to properly self-administer them.
On the other hand, To provide novel therapeutics that are reliable and provide the best treatments for sickness, pharmaceutical scientists research medication action and are engaged in the work of drug development. Professional researchers are employed by biotech and pharmaceutical businesses to conduct trials as part of collaborative data analysis to bring novel medicines to the industry.
Up to the graduate level, pharmacy education and profession are regulated by the pharmacy council of India (PCI). The objectives of PCI are:
- To regulate the pharmacy profession and practice in India.
- To register as a pharmacist under the Pharmacy Act, the country’s pharmacy education is regulated.
Pharmaceutical laws in India:
The International ranking of Indian Pharmaceutical production in terms of volume and value is third and fourteenth respectively. Because of the industry’s capabilities and rising medical standards in the nation, the market pharmacy is continually expanding. The rise of these ranks was witnessed during the period. In such an expansion of the industry, the law sector plays a vital role in that.
The following are some of the important pharmaceutical laws in India:
- The Pharmacy Act, 1948:
Earlier there was no restriction on practicing the profession of pharmacy. People who do not have any knowledge or education are found to be engaged in this profession. This was causing damage to society as people were getting bad or inappropriate medications. Hence, The Pharmacy Act, of 1948 was enacted for a well-regulated pharmacy in terms of its practice and profession.
A Central Pharmacy Council of India is established by the Central Government following the terms of this act, and State Pharmacy Councils are under the State Governments.
- The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945:
Indian Legislature approved the Drugs and Cosmetics Act of 1940, which governs the nation’s importation, production, and drug distribution. The main objective of the Act is to make sure that all medications and cosmetics marketed in India are secure, efficient, and up to par with quality regulations.
The related Drugs and Cosmetics Rules, 1945, provide specifications for classifying medications as well as instructions for each category’s maintenance, distribution, presentation, and prescriptions.
- The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954:
Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 has the following objectives for its enactment:
- To control how medications are advertised,
- To forbid the promotion of cures that are said to possess magical properties, and
- To stop people from using dangerous pharmaceuticals on themselves.
The Drugs and Magic Remedies Act, of 1954 mentions the list of diseases for which advertisement is banned.
- The Narcotic Drugs and Psychotropic Substances Act, 1985:
The Narcotic Drugs and Psychotropic Substances Act, 1985 restricts the following actions considering them illegal. These could be harvesting, manufacturing, owning, selling, buying, producing, consuming, and regulating other operations related to narcotic drugs or psychotropic substances of any kind.
- The Medicine and Toilet Preparations (Excise Duty) Act, 1956
This act is for the estimation of any pharmaceutical as well as toiletry foods that contain alcohol, narcotics, or both. The decided Excise taxes are also collected on mentioned items with the provision of this act.
- The Drugs Price Control Act, 2013:
The joint venture of the Department of Pharmaceuticals and the Ministry of Chemicals and Fertilizers aimed for the affordability factor of medicines. Not all medicines could be pushed to attain the lowest charge possible criteria, but several basic medications can be supplied to the market. When the basic medicines are available to the population at an affordable cost, it would lead to the attainment of the national level healthy status of the population. The main reason to enact this act was to provide patients with medicines at an economical price in India.
The Government of India passed the order following Section 3 of the Essential Commodities Act of 1955 for better control and regulation of the cost prices of medicines in the Indian market. The National Pharmaceutical Pricing Authority (NPPA) holds the authority of the Drugs Price Control Act, 2013.
Regulatory bodies in Pharma and Health Care sector:
The bodies that regulate the Pharma and healthcare sector in India are:
- Ministry of Health and Family Welfare:
Through the Department of Health, the Ministry of Health & Family Welfare oversees the healthcare and pharmaceutical industries in the nation. Central Drugs Standard Control Organization (CDSCO) in association with the Drugs Controller General of India (DCGI) is the main organization of the department that regulate the basic issues of health.
- Ministry of chemicals and fertilizers:
Three departments that together make up the Ministry of Chemicals and Fertilizers are dedicated to the development and regulation of chemicals in the country. This trio is:
- Department of Chemicals and Petrochemicals,
- Department of Fertilizers, and
- Department of Pharmaceuticals
The Indian pharmaceutical industry is a rising competitor. The records, the Pharma production had made during worldwide phenomena of Corona in past two years led the focus of the world shifting towards India. Pharmaceuticals Industry is all about the curing and treatment of diseases through the process of years of research and development, and thereafter large scale production. This industry also works for immunizing a person to deal with any sort of possible risk of any disease.
The prominent provisions are present in the pharmaceutical industries for the proper regulation of the pharmacy and healthcare sectors. Several laws are provided to the pharmaceutical industries for bona fide functioning and providing the best medication and health care services to the citizen of India.
- The Editors of Encyclopaedia Britannica. (pharmaceutical Therapeutic substance). Retrieved: https://www.britannica.com/technology/pharmaceutical
- Pharmacy council of India. Retrieved : https://www.pci.nic.in/GenInfo_About_Introduction.html
- Harman Juneja. (2021, September 20). (Drugs and Cosmetics Act, 1940 : new regulatory regime for eight medical items). Retrieved: https://blog.ipleaders.in/drugs-and-cosmetics-act-1940-new-regulatory-regime-for-eight-medical-items/
- (Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955). Retrieved: https://www.teamleaseregtech.com/resources/acts/article/114/drugs-and-magic-remedies-objectionable-advertisement-act-1954-and-drug/