Scope and Objectives of Pharmaceutical Legislation

Scope and Objectives

The inception of the Drug Bill occurred in 1040 within the Legislative Assembly. After a thorough review by the Select Committee, the Drug Bill of 1940 successfully secured passage. This legislative transition led to the establishment of the Drug Act 1940, which came into effect seven years later in 1947. Over the years, the Drug Act underwent multiple amendments, culminating in its current iteration that encompasses regulations spanning Drugs, Cosmetics, as well as Ayurvedic, Unani, and Homoeopathic medicines.

The contemporary Drugs and Cosmetics Act represents an enhanced and evolved rendition of the original Drug Act from 1940. The principal objective driving this legislation is the meticulous oversight of Drug and Cosmetics importation, manufacturing, distribution, and sales. In line with this, the Central Government has formulated a comprehensive set of regulations, titled "The Drugs and Cosmetics Rules of 1946," which govern the production, distribution, and sales of drugs and cosmetics in India. These statutes and rules are subject to periodic revisions, ensuring their relevance and effectiveness.

Legislative Developments in Pharmacy Regulation in India

Following India's attainment of independence in 1947, a series of vital legislative measures were enacted in alignment with recommendations from the DEC (Drug Enquiry Committee). In 1948, the Pharmacy Act came into existence with the primary objective of effectively overseeing and regulating the pharmacy profession within India.

During the year 1954, the enactment of the Drugs and Magic Remedies (Objectionable Advertisements) Act aimed to exert control over specific categories of drug-related advertisements and, concurrently, to prohibit advertisements promoting magic remedies.

The year 1955 witnessed the establishment of the Medicinal and Toilet Preparations (Excise Duties) Act, which facilitated the imposition and collection of excise duties on medicinal and toilet preparations incorporating substances like alcohol, opium, Indian hemp, or other narcotic drugs. The Central Government introduced corresponding regulations under this Act, recognized as the Medicinal and Toilet Preparations (Excise Duty) Rules of 1956.

Within the framework of the Essential Commodities Act of 1955, and in lieu of the Drug (Prices Control) Order of 1979, the Central Government formulated the Drug (Prices Control) Order of 1987, granting greater control over drug pricing and distribution.

In 1985, the Narcotic Drugs and Psychotropic Substances Act was enacted, which effectively replaced the Dangerous Drugs Act of 1930 and the Opium Act of 1878. The central aim of this legislation was to consolidate and amend existing laws pertaining to narcotic drugs. It also established stringent provisions for controlling and regulating operations linked to narcotic drugs and psychotropic substances. The accompanying Prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances Ordinance of 1988 supplemented this act.

 

Numerous other legislations, either directly or indirectly associated with the manufacture, distribution, and sale of drugs and pharmaceuticals in India, also deserve mention:

 

1. The Prevention of Food Adulteration Act of 1954 and its corresponding rules.

2. The Industries (Development and Regulation) Act of 1951.

3. The Industrial Employment (Standing Orders) Act of 1946 and its rules.

4. The Industrial Disputes Act of 1947.

5. The Factory Act of 1948.

6. The Indian Patent and Design Act of 1970.

7. The Trade and Merchandise Marks Act of 1958.

8. The Epidemic Diseases Act of 1897.

9. Shops and Establishments Acts specific to respective states.