This is the first in a three-part series on regulatory requirements for clinical trials in India.


When it comes to regulating clinical trials in India, change is afoot. G.N. Singh, the Drug Controller General of India (DCGI) recently announced that his government would soon unveil a new clinical trials policy. The announcement he made at the India BioPharma and Healthcare Summit in Boston promised greater transparency and better patient safety checks – welcome news to industry stakeholders who had been awaiting updates in regulations.

The Indian pharmaceutical market is worthy of attention. It’s the third largest globally by volume and 13th largest by value. The country is also the biggest producer of generic drugs, accounting for 20% of global exports in volume.

Recently, consolidation has been the hallmark of the highly fragmented , where only 1.4% of global clinical trials are conducted despite the country being home to 16% of the world’s population and 20% of the world’s disease burden. However, a series of blemishes in clinical research has shaken worldwide confidence. As a result, the last few years has witnessed a slowdown in the amount of clinical trials in India amid tedious litigation and rising protests from health activists over informed consent and compensation norms.

To help you understand where its reforms are headed, we’ve outlined India’s early history of regulations and existing laws below.

History of clinical trials in India

In 1995, India signed the World Trade Organization’s Trade Related Intellectual Property Rights (“TRIPS”) agreement that was aimed at harmonizing intellectual property rights and patent protection globally. A decade later it introduced the Patents (Amendment) Act and revised its weak process patent to a stronger, TRIPS-compliant product patent system for pharmaceutical products. These legislative changes not only provided foreign companies access to the Indian market, but also allowed the introduction of internationally-funded clinical trials.

From 2005 to 2009 clinical trials sprang up throughout the country, thanks to an overwhelming torrent of contract research organizations and trial sponsors. Multinational pharmaceutical companies increased their Indian drug discovery, contract manufacturing and clinical research. They were enticed by the sheer size of the domestic market, as well the potential to minimize costs and maximize efficiency, while still adhering to international standards for clinical research quality.

Other factors also played in India’s favor. Along with a large population and genetic pool, the country offered highly skilled medical investigators and related professionals like physicians, nurses, clinical research assistants and clinical practitioners. On top of that, India had a reputation for completing timely trials.

How India has governed its clinical research

Similar to its counterparts such as the FDA, Health Canada and the European Medicines Agency, the Central Drugs Standard Control Organization (“CDSCO”) is the national regulatory authority in India. As an official of the CDSCO, Mr. Singh is the final regulatory authority for the approval of clinical trials in India. The Indian Council of Medical Research (“ICMR”), meanwhile, is the regulatory body that is responsible for the formulation, coordination and promotion of biomedical research in India.

Below, find details about India’s current regulatory framework and guidelines governing clinical research:

  1. Drugs and Cosmetic Act, 1940 revised in 2005 (“DCA”) and Drugs and Cosmetics Rules, 1945

The DCA regulates the import, manufacture and distribution of drugs in the country to ensure that drugs and cosmetics sold are safe, effective and conform to essential quality standards. The Schedule Y of the Drugs and Cosmetics Rules, 1945 (“Schedule Y”) along with rules 122A, 122B, 122D, 122DA, 122DAC and 122E, establish a set of guidelines and requirements for clinical trials.

However, Schedule Y was written with the generics industry in mind. The entry of foreign pharmaceutical companies into India (as discussed above) led the government to introduce many changes and adapt ethical and regulatory guidelines. A change in the Schedule Y removed a phase-lag in clinical trials: Pharmaceutical companies could conduct trials of new drugs in India at the same time that trials of the same phase were being conducted in other countries.

  1. Ethical Guidelines for Biomedical Research on Human Participants (“EG”) published by the ICMR, 2006

The ICMR first issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000. The revised guidelines released in 2006 are called the Ethical Guidelines for Biomedical Research on Human Participants and they remain valid today. These guidelines cover the general principles that need to be followed by every biomedical researcher and offer guidance regarding special areas of research, such as that involving children or herbal medicine. Researchers are expected to be familiar with both of these documents and abide by the requirements in the former and the guidance in the latter. ICMR is expected to release revised guidelines in 2017.

  1. Good Clinical Practices for Clinical Research in India (“GCP”)

Good clinical practice guidelines were released in 2002 by the CDSCO with the goal of being India specific. However, unlike the International Conference of Harmonization GCP guidelines (“ICH GCP”), India’s version has not been revised since they were first adopted. Meanwhile, ICH GCP guidance provides a unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

The bottom line

Although India’s clinical trial regulations have evolved considerably to match global standards, many issues still remain.

Keep an eye out for our second instalment of Clinical Trials in India, which will examine the issues and why better regulations are necessary.