Fig. 7.1: Relation between regulatory professionals of company and the government regulatory

authority

Regulatory Affairs and its Role 115

7.2 HISTORICAL OVERVIEW OF REGULATORY AFFAIRS

The quality assurance and regulation of medicines evolved gradually over time. Many

unfortunate incidents have catalysed the development of regulations and guidelines

of assuring quality, safety and efficacy of medicines. In 1947, in United States over

100 died due to sulphanilamide elixir. This event led to the introduction of Federal

Food and Cosmetics Act for new drugs in 1948. In 1956, the introduction of Thalidomide

(a drug prescribed to pregnant women for morning sickness) in 46 different countries

resulted in an estimated 10000 babies born with phocomelia (Deformities related to

limbs). This event results in reshaping of the whole regulatory system. Due to these

types of incidents at different stage regulatory bodies introduce new laws and

guidelines which make norms related to drug approval or site approval stricter than

before. Due to more guidelines and laws, the need for regulatory affairs has been felt.

It led to the emergence of regulatory affairs as a profession (Table 7.1)

Fig. 7.2: The connection of regulatory affairs department with other departments in company

Table 7.1: Chronological evolution of regulatory affairs

Sr. no. Year Content

1. 1540 In England the manufacturers of medicines were subjected to supervision

under an act known as Apothecaries Wares Drugs and Stuffs Act.

2. 1581 The first pharmacopoeia is known as Spanish pharmacopoeia

3. 1618 The London pharmacopoeia

4. 1938 Introduction of Federal Food, Drugs and Cosmetics Act

5. 1940 and 1945 Drugs and Cosmetics Act 1940 and Rules 1945

6. 1962 Drug Amendment Act of 1962 was passed by FDA which for the first

time demanded that:

1. A new drug should be proven to be effective and safe

2. All manufacturing sites are required to comply with CGMP

7. 1963 Establishment of a committee on safety of drugs

Contd.

116 Industrial Pharmacy II

The whole world is divided into three types of countries: Regulated (like United

States, European Union, Australia, Japan, etc.) , semi-regulated (like India, Indonesia),

and not regulated (like Cambodia, Burundi, Burkina Faso etc.) depending upon the

organisation structure of government regulatory authority, availability of resources

and execution of guidelines.

7.3 REGULATORY AUTHORITIES

For every country, the health of its people is of utmost importance. To maintain the

health of the people, country has to ensure the quality of medicines and other

pharmaceutical products as well as devices. So, every country has its regulatory

authority which regulates the following: (Table 7.2)

1. Import of drugs from another country

2. Export of drugs to another country

3. Manufacturing of drugs in the country

4. Establishment of manufacturing companies in the country