Indian Pharmaceutical Legal & Regulatory Environment
The pharmaceutical industry is one of the most regulated industries in India. It not only caters to national but also global demand for medicines and drugs. This article tells you about the legal and regulatory environment of the Indian pharmaceutical industry.
We, as Indians can proudly say that India ranks 3rd as the exporter of drugs and medicines, and is one of the largest providers of generic drugs and medicines in the global market. Since Indian drugs manufacturers cater to the enormous global demand, the drugs have to confer to the acceptable international safety and quality standards.
Regulatory framework
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Drugs and Cosmetics Act, 1940 and drugs and Cosmetics Rules,1945
The enforcement of the Drugs and Cosmetics Acts and Rules is overseen by the Central Government and the State Governments. The Drug Controller General of India heads the Central Drugs Standard Control Organization. The organization is primarily responsible for coordinating the activities of the State Drugs Control Organization, ensuring uniform implementation of the Act and Rules throughout India, and Formulating policies.
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Pharmacy Act, 1948
This Act regulates the profession of pharmacy in India including education and practice of pharmacy and specifies the offenses while practicing the profession of pharmacy by a registered pharmacist, which can lead to penal action under the Act, and even permanent deregistration.
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The Drugs & Magic Remedies Act, 1954 and the Drugs and Magic Remedies Rules, 1955
This Act was passed to regulate the advertisements of drugs relating to diagnosis, cure, treatment, or prevention of certain diseases and conditions in India. The Act prohibits the advertisements of drugs, like antidiabetic agents, and remedies that claim to have magical properties and make doing so, a cognizable offense. These diseases and conditions include AIDS, Asthma, Cancer, and other such illnesses.
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Drugs Price Control Order, 2013
This order was issued by the Government of India under Section 3 of the Essential Commodities Act, 1955; and supersession of Drug Order, 1955. Under this Act, drugs have been declared as essential and accordingly put under the Essential Commodities Act, 1955. This order provides a list of procedures for drugs manufacturers for fixation of drug prices; price-controlled drugs; penalties for contravention of provisions; and method of implementation of prices fixed by the government.
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Narcotic Drugs and Psychotropic Substances Act, 1985
Under this Act, it is illegal for a person to produce, cultivate, manufacture, sell, purchase, possess, store, transport, or consume any narcotic drug or psychotropic substances. The Act is designed to fulfill India's treaty obligations under the Single Convention on Narcotic drugs, Convention on Psychotropic Substances, and United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
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Medical Devices Rules, 2017
These rules aim at bringing the entire universe of devices within its purview, by notifying them as 'drugs' in a phase-wise manner, thus bringing the, within the jurisdiction of the Central Drugs and Cosmetics Organization. Regulatory approvals are required according to the Medical Device Rules and subsequent notification of medical devices.
Conclusion
The pharmaceutical industry in India continues to develop and expand steadily, especially in the field of antidiabetic agents. This is due to the significant overall increase in the research and development expenditure. But the industry continues to be heavily regulated.
Supra Chemicals is one of the largest manufacturers of antidiabetic bulk drugs and drug intermediates in India. These drugs include glipizide, glimepiride, and sulfonamides. They also manufacture diuretics and antihypertensive drugs.
