Regulatory Practice

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Medicines and Healthcare Products Regulatory Agency (MHRA) 

The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989.

Registration, Evaluation Authorisation and Restriction of Chemicals (REACH) program 

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006.[ REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union’s history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.

Central Drug Standard Control Organization (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed. 

Though the CDSCO has a good track record with the World Health Organization, it has also been accused of past collusion with independent medical experts and pharmaceutical companies. CDSCO plans to open international offices in Beijing, China.

The Environmental Protection Agency (EPA)

The United States Environmental Protection Agency (EPA or sometimes U.S. EPA) is an agency of the federal government of the United States which was created for the purpose of protecting human health and the environment by writing and enforcing regulations based on laws passed by Congress.President Richard Nixon proposed the establishment of EPA and it began operation on December 2, 1970, after Nixon signed an executive order. The order establishing the EPA was ratified by committee hearings in the House and Senate. The agency is led by its Administrator, who is appointed by the President and approved by Congress. The current Administrator is Scott Pruitt. The EPA is not a Cabinet department, but the Administrator is normally given cabinet rank.

The EPA has its headquarters in Washington, D.C., regional offices for each of the agency’s ten regions, and 27 laboratories. The agency conducts environmental assessment, research, and education. It has the responsibility of maintaining and enforcing national standards under a variety of environmental laws, in consultation with state, tribal, and local governments. It delegates some permitting, monitoring, and enforcement responsibility to U.S. states and the federally recognized tribes. EPA enforcement powers include fines, sanctions, and other measures. The agency also works with industries and all levels of government in a wide variety of voluntary pollution prevention programs and energy conservation efforts.

In 2016, the agency had 15,376 full-time employees. More than half of EPA’s employees are engineers, scientists, and environmental protection specialists; other employees include legal, public affairs, financial, and information technologists. In 2017 the Trump administration proposed a 31% cut to the EPA’s budget to $5.7 billion from $8.1 billion and to eliminate a quarter of the agency jobs.

Central Insecticides Board

Although most of the dangers from unregulated and indiscriminate use of pesticides were brought into focus as early as in the year 1958 when the Government of India appointed a Commission of enquiry to suggest Inter-alia remedial measures following a number of deaths in Kerela and Madras (Tamil Nadu) by poisoning through the consumption of imported wheat contaminated by pesticide accidentally which was shipped together with food grains. The whole question of pesticide use and legislation was studied in 1964-67 by an Expert Committee of Indian Council of Agricultural Research headed by Prof. M.S. Thacker. Based on the recommendations of the Expert Committee a comprehensive Insecticides Act was passed in 1968 to regulate the import, manufacture, sale, transport, distribution and use of insecticides with a view to prevent risks to human beings and animals and for other matters connected therewith. The enforcement of Act was tranferred to the Ministry of Agriculture in the year 1970 by the Ministry of Health and family Planning. The department of Agriculture of this Ministry took immediate steps to frame the Rules and constituted Central insecticides Board and Registration committee. The states were simultaneously advised to appoint all functionaries mentioned in the Act. After the stage was fully set, all the provisions of the Insecticides Act was brought into force with effect from 1st August, 1971. In the Act and the Rules framed there under, there is compulsory registration of the pesticides at the Central level and licence for their manufacture, formulation and sale are dealt with at the State level. With the enforcement of the Insecticides Act in the country pesticides of very high quality are made available to the farmers and general public for house-hold use, for protecting the agricultural crops from the ravages of their pests, humans from diseases and nuisance caused by public health pests and the health hazards involved in their use have been minimised to a great extent. For the effective enforcement of the Insecticides Act, the following bodies have been constituted at the Central level.

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