Why India Needs Stronger Regulation

When I joined the national standards body in 1980—then called the Indian Standards Institution (ISI), now the Bureau of Indian Standards (BIS)—we underwent extensive classroom training in standardization and certification. One of the concepts we learned was the distinction between voluntary and mandatorystandards. The latter referred to those enforced by law.

At the time, aside from food and drug regulations, only a few products—like mild steel tubes and LPG cylinders—were subject to mandatory standards based on Indian Standards, with ISI involved in enforcement.

The landscape changed dramatically in 1995 with the establishment of the World Trade Organization (WTO) and the signing of agreements like the Technical Barriers to Trade (TBT) and Sanitary and Phytosanitary Measures (SPS), to which India is also a signatory. These agreements replaced the term “mandatory standards” with “technical regulations” for goods, and “SPS measures” for agricultural and food products. Voluntary standards remained under the umbrella of "standards" in the new terminology.

Additionally, the General Agreement on Trade in Services (GATS) introduced similar concepts for services, distinguishing between voluntary standards and mandatory regulations.

Unfortunately, this shift has caused significant confusion in India—among policymakers, industry leaders, and even the general public. We often continue to conflate standards and regulations, despite their distinct roles in the global system.

Why Regulate?

Globally, it is well accepted that products or services that pose risks to health or safety should be regulated. For example, food and drugs are regulated for health reasons, while LPG cylinders, valves, and electrical appliances are regulated for safety.

The TBT Agreement outlines the justifications for regulation—health, safety, environmental protection, prevention of deceptive practices, and national security. The use of the phrase “such as” allows for additional grounds to be added, and they have been—such as climate action, sustainability, and energy efficiency.

Cement was regulated in the early 1980s due to rampant adulteration. Today, gold jewellery is regulated for the same reason. Chemicals and fuels like petrol and diesel are regulated to protect the environment. Telecom products, due to potential national security concerns (e.g., spying), also require regulation.

Under GATS, similar justifications exist for services, with the addition of data privacy and public order. Healthcare, which clearly warrants regulation, remains mostly unregulated in India. Education is regulated primarily to prevent fraud and malpractice.

India’s Digital Personal Data Protection Act, 2023, is a recent step in the right direction, acknowledging the importance of privacy and regulation in the digital space.

The Role of Government

Regulation is fundamentally the responsibility of the government. Citizens have a right to expect the state to safeguard public interest by regulating products and services that could affect their health, safety, or well-being.

Think back to the onset of COVID-19 in early 2020. Products like PPE kits, masks, oximeters, and ventilators were widely discussed—but none were regulated at the time. Consequently, the market was flooded with products of uncertain quality and safety. Thankfully, medical devices are now regulated.

Despite frequent claims that India is “overregulated,” especially after economic liberalization, the reality is quite the opposite—particularly in terms of technical regulation. Until recently, chemicals, telecom, medical devices, and most electrical equipment were largely unregulated. Machinery still isn’t fully regulated, though notifications have been issued.

In mid-2017, the government finally acknowledged the dangers of weak regulation and began a structured effort to address it. At that time, only about 125 BIS standards were notified for mandatory compliance. Today, that number has grown to around 800.

A Crisis in Service Regulation

The situation in services is even worse. Healthcare remains mostly unregulated. Even the minimum standards for hospitals under the Clinical Establishments Act have not been notified. Though medical laboratories are covered, enforcement is weak.

This is further complicated by India’s federal structure. Many services, including healthcare, fall under the State List, requiring individual states to enact regulations. In contrast, product regulation falls under the Central List.

Despite having a dedicated Department of Consumer Affairs, India has lacked a comprehensive and coordinated approach to regulation. Weak consumer movements and limited awareness among stakeholders—whether policymakers, industry, or civil society—have contributed to this gap.

Time for Change

India must prioritize the regulation of products and services that have implications for public health, safety, the environment, or fair trade practices. This is not merely a bureaucratic necessity—it is a matter of protecting the common man.