How medicines and doctors are regulated in India and the US

When you take a tablet or visit a doctor, two systems of rules sit in the background. One decides which medicines may be sold and under what conditions. The other decides who may practise as a doctor. This article explains how medicines are regulated in India and the United States and how doctors are regulated in India, using information from the Directorate General of Health Services in India, the US National Institutes of Health, the US Food and Drug Administration (FDA) and the World Health Organization (WHO). It describes the system of modern medicine, often called allopathy, and is general information only.

1. Introduction

WHO says medicines must meet required standards of quality, safety and efficacy (how well they work), and must also be made, stored, distributed and supplied properly ^[6]. Regulators are also expected to detect and penalise illegal manufacture and trade, and to make sure health professionals and patients have the information they need to use medicines responsibly ^[6]. A WHO Bulletin article explains that regulating health practitioners is designed to address the gap in knowledge between patients and practitioners and to reduce the risk of harm to patients ^[5].

2. Who regulates medicines in India

The Central Drugs Standard Control Organization (CDSCO) is India's central authority for the quality of drugs. It is headed by the Drugs Controller General of India and works under the Drugs and Cosmetics Act, 1940, from New Delhi, with zonal and sub-zonal offices, testing laboratories and port offices ^[1].

Several sets of rules apply, including the Drugs Rules 1945, the Medical Devices Rules 2017, the New Drugs and Clinical Trials Rules 2019 and the Cosmetics Rules 2020 ^[1]. According to the Directorate General of Health Services, CDSCO's work includes ^[1]:

• Approving new drugs and clinical trials.
• Registering and licensing imports.
• Licensing blood banks and vaccines, among other products.
• Banning drugs and cosmetics when needed.
• Pharmacovigilance, which means monitoring the safety of medicines once people use them.

The stated aim is that drugs, cosmetics and medical devices are safe, effective and of good quality ^[1]. Trials of new medicines in India need approval from CDSCO and a registered ethics committee, and CDSCO can inspect trial sites and suspend permission if rules are broken ^[2].

3. Who regulates medicines in the United States

The FDA describes five steps in drug development: discovery, preclinical research in laboratories and animals, clinical research in people, FDA review, and safety monitoring after the product is sold ^[3].

Before testing in people, the company or institution developing a drug, called the sponsor, submits an Investigational New Drug application with animal data and a plan for human testing. The FDA decides whether testing in humans is reasonably safe, and an institutional review board must also approve the plan ^[4]. Trials then run in phases of increasing size, with phase 3 involving several hundred to about 3,000 people ^[4].

The sponsor then submits a New Drug Application containing all the data. The FDA has 60 days to decide whether to file it for review, and its goal is to act on at least 90 percent of standard applications within 10 months ^[4]. After approval, the FDA may require or accept commitments for further studies on safety and effectiveness ^[4]. Sponsors take responsibility for developing the drug, and the FDA reviews their data ^[4].

4. What this means for you

• A medicine that is on sale has gone through review, but it can still cause side effects, which is why safety is monitored after approval ^[3].
• If you have an unexpected reaction, tell your doctor or pharmacist.
• Use medicines only as prescribed, and keep your doctor informed about every treatment, including supplements.

5. How doctors are regulated

WHO describes the usual parts of regulating health practitioners as education standards, registration or licensing, a public register and a process for handling complaints and misconduct ^[5].

In India, the National Medical Commission (NMC) Act of 2019 replaced the Medical Council of India ^[5]. The NMC has a medical advisory council and four autonomous boards. A national entrance exam is required for undergraduate medical programmes, and a common national exit exam is required for registration or licence to practise and for entry to postgraduate training ^[5]. This links registration to a national standard of training.

Because registers and rules change, you can check current details with the official NMC register or your state medical council if you want to confirm a doctor's registration.

Whatever system of medicine you use, ask your practitioner about their registration and tell your doctor about every treatment you use. Other systems, such as the AYUSH systems, are covered in other articles in this library.

6. When to see a doctor

Contact your doctor or pharmacist if a medicine causes a reaction you did not expect, if you are unsure how to take it, or if you have concerns about a product you bought. Do not stop a prescribed medicine on your own. If you have doubts about the care you receive, you can ask for a second opinion. In an emergency, call your local emergency number (112 in India, 911 in the United States).

7. Conclusion

Regulators in India and the United States review the quality, safety and effectiveness of medicines before and after they reach patients. Doctors are held to training and registration standards, which in India are now overseen by the National Medical Commission. These systems lower risk but cannot remove it, so your own habits count: take medicines as prescribed, report problems and keep your doctor fully informed.