1. The Indian Patent and Design Act, 1970

Focused on encouraging innovation, this act initially allowed only process patents, enabling Indian companies to produce affordable generic drugs. Over the years, the act evolved, aligning with international standards to balance innovation with affordability, crucial in the pharmaceutical sector.

2. The Drugs and Cosmetics Act, 1940 and Rules, 1945

As a foundational piece of legislation, this act covers the manufacturing, sale, and distribution of drugs and cosmetics in India. It ensures drugs’ safety and efficacy, setting the groundwork for regulatory compliance in the pharma sector.

3. The Industrial Employment (Standing Orders) Act, 1946

Although not exclusive to pharmacy, this act plays a crucial role in defining terms of employment and labor practices, supporting fair treatment and dispute resolution in pharmaceutical manufacturing and other industries.

4. Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985

To address drug misuse and illegal distribution, the NDPS Act governs the production, trade, and use of narcotic substances. This act enforces stringent regulations to prevent abuse while permitting necessary medical and scientific applications.

5. The Pharmacy Act, 1948

This act was designed to regulate the pharmacy profession, setting standards for pharmacy education and practice. It led to the establishment of the Pharmacy Council of India (PCI), which ensures that pharmacists are well-trained and qualified for their roles.

6. The Drugs Price Control Order (DPCO), 1995

Aimed at making essential drugs affordable, the DPCO capped prices on critical medicines, balancing public accessibility with industry growth. A revised version introduced in 2013 focused on life-saving drugs, reinforcing the government’s commitment to healthcare affordability.

7. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

With a focus on consumer protection, this act prevents misleading advertisements for drugs with exaggerated or magical claims. It emphasizes transparency and evidence-based treatment, safeguarding public health against fraud.

8. The Factories Act, 1948

While generally applied to various industries, this act mandates safe and healthy working conditions in manufacturing units, including pharmaceutical facilities. It provides guidelines on employee welfare, emphasizing occupational safety.

9. The Trade and Merchandise Marks Act, 1958

This act protects brands in the pharmaceutical industry, especially critical for over-the-counter products where brand trust is key. By governing trademarks, it helps maintain brand integrity and prevents consumer confusion.

10. The Poison Act, 1919

The Poison Act regulates the sale and possession of poisons, ensuring responsible handling and preventing misuse. It includes guidelines for labeling and storage, vital in managing hazardous substances often used in pharmaceutical manufacturing.

11. Medical and Toilet Preparations (Excise Duties) Act, 1955, and Rules, 1976

Focused on excise duties, this act governs medical and toiletry preparations containing alcohol or narcotics. By regulating such products, it ensures these preparations are handled safely and responsibly.

12. Medical Termination of Pregnancy (MTP) Act, 1971

The MTP Act provides a legal framework for safe abortion practices, specifying conditions under which medical termination is permitted. This act protects women’s health and autonomy in reproductive decisions.

13. The Industries (Development and Regulation) Act, 1951

Regulating industrial growth, this act requires licensing and sets standards to ensure balanced development across industries, including pharmaceuticals. It fosters a healthy market environment by preventing monopolies and supporting fair competition.

14. The Epidemic Diseases Act, 1897

One of India’s oldest healthcare laws, this act empowers government authorities to control epidemics. Recently used during the COVID-19 pandemic, it provides legal grounds for quarantine and other necessary measures to contain contagious diseases.

15. The Prevention of Food Adulteration Act, 1954

Targeting the quality of consumables, this act overlaps with pharmaceutical regulations, especially in the realm of nutraceuticals and dietary supplements. It safeguards public health by enforcing strict standards against adulterated or contaminated products.

16. The Opium Act, 1978

As part of India’s commitment to controlling narcotics, this act regulates the use, production, and trade of opium. It establishes guidelines for legitimate medical and scientific usage while deterring illegal drug-related activities.

17. New Drug Policy, 1994

This policy promoted innovation in drug development while ensuring that essential medicines remain accessible. It aimed to support both domestic and global competitiveness, fostering growth in the Indian pharmaceutical sector.