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A Guide to India Clinical Trial Regulations (Part 1): History & Overview

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. In 2017, the Drug Controller General of India announced a new clinical trials policy. This policy provided greater transparency and better patient safety checks. 

India is home to 16% of the world’s population. 20% of this population is disease burden. India conducts clinical trials at a very low rate (1.4% of global clinical trials). A series of blemishes in clinical research has shaken worldwide confidence. There have been fewer clinical trials in India due to tedious litigation. Another cause is rising protests from health activists over informed consent and compensation norms. 

To help you understand the regulations, we’ve outlined India’s early history of governing bodies 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. The purpose was to harmonize intellectual property rights and patent protection globally. A decade later, it introduced the Patents (Amendment) Act. India revised its weak process patent to a more robust, TRIPS-compliant product patent system for pharmaceutical products. 

These legislative changes gave foreign companies access to the Indian market and allowed internationally-funded clinical trials.

From 2005 to 2009, clinical trials sprang up throughout the country. This is 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. The sheer size of the domestic market enticed these companies. The potential to minimize costs and maximize efficiency while still adhering to international standards for clinical research quality was attractive.

The country offered a large population and genetic pool. This includes highly skilled medical investigators and related professionals. For instance, physicians, nurses, clinical research assistants, and clinical practitioners. On top of that, India had a reputation for completing timely trial research.

How India Has Governed its Clinical Research?

Like the FDA, Health Canada, and the European Medicines Agency, India has its own national regulatory authority. India’s equivalent is the Central Drugs Standard Control Organization (“CDSCO”). As an official of the CDSCO, the Drug Controller General is the final regulatory authority for approval of clinical trials. The Indian Council of Medical Research (“ICMR”) is another important regulatory body. This body is responsible for the formulation, coordination, and promotion of biomedical research in India.

India Governing Regulations

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

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. The DCA ensures that drugs and cosmetics sold are safe, effective, and conform to essential quality standards. Specific provisions establish a set of guidelines and requirements for clinical trials. First, the Schedule Y of the Drugs and Cosmetics Rules, 1945 (“Schedule Y”). And, the second, the rules 122A, 122B, 122D, 122DA, 122DAC, and 122E. However, the regulators wrote Schedule Y with the generics industry in mind. The entry of foreign pharmaceutical companies into India led the government to introduce changes and adopt ethical and regulatory guidelines. A change in the Schedule Y removed a phase-lag in clinical trials. Pharmaceutical companies could conduct tests of new drugs in India as similar trials were conducted in other countries.

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. Released in 2006, the revised guidelines are the Ethical Guidelines for Biomedical Research on Human Participants. These guidelines still remain valid today. They cover the general principles that need to be followed by every biomedical researcher. Also, they offer guidance regarding select areas of research, such as those involving children or herbal medicine. Researchers are expected to be familiar with both of these documents. Additionally, they are expected to abide by the requirements in the former and the guidance in the latter.

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

Good Clinical Practice Guidelines were released in 2002 by the CDSCO. Unlike the International Conference of Harmonization GCP guidelines (“ICH GCP”), India’s version has not been revised since the initial adoption. Meanwhile, ICH GCP guidance provides a unified standard for the European Union, Japan, and the United States. This standard facilitates the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

What Clinical Trials in India Look Like Today 

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

Check out Part II to learn more about the issues and why better regulations are necessary.

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