EXPLAINED: What is Plaguing the Drug Regulation in India?

Explainer Government Medical

India’s gleaming reputation as the “Pharmacy of the World” has been severely tarnished in recent months due to a series of incidents involving drug malfunctions that have resulted in illness and deaths, particularly among children. 

From cough syrups causing the death of 70 children due to acute kidney injuries in The Gambia to toxic substances in cough syrup leading to the deaths of 18 children in Uzbekistan, and an eye infection outbreak in the United States linked to an Indian-manufactured eye drop, these incidents have raised concerns about drug safety and regulation in the country. 

In response, India’s health ministry has proposed the formulation of common standards for drug regulators at the central and state levels and the establishment of a central database to better monitor the manufacturing, sale, and distribution of drugs.

In this article, we will explore the current state of drug regulation in India and the potential impact of these proposed reforms.

Drug Regulation in India

Drug regulation is the process of ensuring that pharmaceutical products available to the public are safe, effective, and of high quality. 

The regulatory framework for drug regulation in India is based on the Drugs and Cosmetics Act, 1940 (DC Act) and the Drugs and Cosmetics Rules, 1945 (DC Rules).

The regulation of drugs in India is divided between state and central authorities. Currently, there are 38 drug regulators in India – one for each state and union territory – along with the national regulator known as the Central Drug Standard Control Organisation (CDSCO). Each regulator operates its own set of laboratories, inspectors, and jurisdiction.

State authorities are responsible for overseeing the manufacture, sale, and distribution of drugs, while the central authorities approve new drugs, conduct clinical trials, set drug standards, monitor the quality of imported drugs, and coordinate with state drug control organizations.

In summary, drug regulation in India is a multi-stage process that involves both the central and state governments.

Function of the CDSCO

Under the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO) is responsible for the regulation of drugs and medical devices in India. 

It is tasked for approving new drugs, clinical trials, laying down the standards for drugs, monitoring the safety and efficacy of existing drugs, regulating manufacturing, control over the quality of imported drugs and among others.

The CDSCO plays a crucial role in drug regulation in India by coordinating with various State Drug Regulatory Authorities (SDRAs) and providing expert advice to ensure uniformity in enforcing the Drugs and Cosmetics Act. 

Additionally, the CDSCO has the power to ban harmful or sub-therapeutic drugs under Section 26A of the act and issues licenses to government hospitals or medical institutions to import drugs for patient use.

Process of drug approval in India

Before a new drug can be sold in India, it must go through a series of tests to ensure that it is safe and effective for human use with the approval from the Drug Controller General of India (DGCI). 

These tests are conducted under the New Drugs and Clinical Trials Rules, which are enforced by the CDSCO. 

The drug approval process involves several stages, including clinical trials and post-marketing studies. 

1. Drugs are first tested on animals to determine their effectiveness. 

2. If the results are positive, the company can request the DCGI office for human trials. 

3. A subject expert committee (SEC) at the DCGI office then reviews the findings and grants permission for human trials accordingly. 

4. The SEC regularly evaluates the results of human trials and recommends authorisation of drugs based on the findings presented by the pharma companies in the three phases of human trials.

The regulatory framework is designed to ensure that drugs available to the public are safe, effective, and of high quality.

Challenges before Drug Regulation in India

A 2019 report by non-profit Thakur Foundation highlighted several issues that are plaguing drug regulation in India:

1. Inadequate numbers of drug inspectors

2. No records or databases of errant drug manufacturers 

3. Lack of enforcing recalls and uneven punishing violators

4. Poor communication between state and central drug regulatory bodies 

Drug regulation in India faces challenges due to information asymmetry across the different layers of the regulatory and enforcement mechanism. This lack of transparency affects the enforcement and prosecution of offenses, benefiting repeat offenders. 

Problems of Indian Substandard drugs 

India has a problem of both substandard drugs. The United States Food and Drug Administration has many times issued notices over the poor quality of drugs manufactured in India. 

In 2019, the US has blamed India for being a major source of counterfeit drugs globally. Research indicated that counterfeit drugs made up as much as 20% of all medications sold in India. Studies have suggested that up to 20% of all drugs sold in the Indian market are counterfeit. However, India has refuted the report, dismissing it as an assault on affordable generic drugs.

Last year, World Health Organization said 69 children in The Gambia died due to kidney injuries that may be linked to contaminated cough and cold syrups made by New Delhi-based Maiden Pharmaceuticals.

A few months later, at least 18 children died after consuming a syrup manufactured by Indian drugmaker Marion Biotech Pvt Ltd. A batch of syrup contained ethylene glycol, which is a toxic substance.

Recently, FDA warns consumers in the US not to purchase or use EzriCare Artificial Tears due to potential contamination. This over-the-counter product is manufactured by Global Pharma Healthcare Private Limited.

Proposed Common Drugs Standards 

In response to the recent global deaths linked to the consumption of drugs manufactured in India, the Indian government is reportedly considering a significant overhaul of drug regulation in the country. 

According to media reports, the ministry is exploring the possibility of formulating common standards for drug regulators at the Centre and the states and creating a central database to better regulate the manufacturing, sale, and distribution of drugs.

It is considered that if implemented, this move has the potential to significantly improve the drug regulatory system by eliminating redundant monitoring agencies and bringing it up to international standards.

The current drug regulatory mechanism in India is ineffective due to the lack of a consolidated public database recording violations of each licensed company, resulting in a lack of information sharing between states and the CDSCO. This has led to a need for common standards and regulations to be implemented. India’s pharmaceutical industry has a large global profile, making it essential to address these issues, writes Telangana Today.

In summary, drug regulation in India is plagued by problems of information asymmetry, varying quality of regulation across states, and incidents of substandard drugs. The Union Health Ministry’s proposal for formulating common standards for drug regulators at the Centre and the states and maintaining a central database is a positive step. 


Title:EXPLAINED: What is Plaguing the Drug Regulation in India?

By: Mayur Deokar 

Result: Explainer