Issues with the drug regulatory system in India – Explained, pointwise

Introduction

The Indian pharmaceutical industry gained global recognition during the pandemic for its role in exporting drugs, medical equipment, and vaccines to other nations. However, a series of incidents in the past six months have threatened to damage India’s reputation as a “pharmacy to the world.” These incidents include deaths in Gambia linked to cough syrups made by Indian companies and an eye infection outbreak in the US caused by an Indian-produced eye drop. These incidents have raised concerns about drug regulation in India, its safety and quality standards.  

About the drug regulatory system in India

Drug regulation in India involves multiple government bodies and laws, both for domestic and exported drugs. Here are some key points:  

Drug regulation of Domestic Drugs:  

Central Drugs Standard Control Organization (CDSCO): The CDSCO is the primary regulatory body in India that regulates the manufacture, sale, and distribution of drugs in the country. It also conducts periodic inspections of drug manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP) and other regulations.  

Drug Controller General of India (DCGI): The DCGI is responsible for approving new drugs for marketing in India, and for monitoring their safety and efficacy.  

Drug Price Control Order (DPCO): The DPCO regulates the prices of certain essential drugs in India to ensure they remain affordable to the general public.  

State-level drug regulatory bodies: At the state level, there exist State Drug Regulatory Authorities (SDRAs), which are statutory bodies created under the Drugs and Cosmetics Act, 1940. They fall under the ambit of the respective Health Departments of each state.  

Drugs and Cosmetics Act, 1940 and its associated rules: Domestic drugs are regulated under this act.  

Drug regulation of Exported Drugs:  

CDSCO: It is responsible for regulating the export of drugs from India. It issues certificates of pharmaceutical products (CPP) to ensure that drugs exported from India meet the quality, safety, and efficacy standards of the importing country. The CDSCO also regulates the labelling, packaging, and transportation of drugs exported from India.  

The Directorate General of Foreign Trade (DGFT):  The Directorate General of Foreign Trade (DGFT) organisation is an attached office of the Ministry of Commerce and Industry and is headed by the Director General of Foreign Trade. The DGFT issues guidelines for the export of drugs, including the requirement of obtaining necessary licenses, permits, and certificates. Exporters must obtain an Import-Export Code (IEC) from the DGFT to export drugs.

Export Inspection Council (EIC):  The role of the EIC is to ensure that products notified under the Export (Quality Control and Inspection) Act 1963 are meeting the requirements of the importing countries in respect of their quality and safety.

Drugs and Cosmetics Act, 1940 and the Foreign Trade (Development and Regulation) Act, 1992: Exported drugs are regulated under the provisions of these two acts.  

The World Health Organization (WHO): It pre-qualifies certain drugs manufactured in India for use in its global health programs.  

The United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) also regulate drugs manufactured in India for export to their respective countries.  

What are the recent irregularities in Indian drug industries?  

The Indian drug industry has faced several irregularities in recent years, including:  

Quality Control Issues: There have been several instances where Indian drug manufacturers have been found to be violating quality control regulations, leading to substandard or fake drugs in the market. For example, In January (2023), eye drops manufactured by a Chennai-based pharma company were found to be contaminated with a deadly drug-resistant bacterium.  

Data Manipulation: In 2020, India’s drug regulator found that a Hyderabad-based pharmaceutical company had submitted manipulated data to get approval for a drug used to treat bacterial infections.  

Non-Compliance with Regulations: Indian drug manufacturers have been accused of noncompliance with regulations and not following good manufacturing practices. For example, officials from the Haryana Food and Drug Administration inspected Maiden’s manufacturing plant at Sonipat following the WHO alert, they found several discrepancies in the records, due to which the quality of the raw material could not be ascertained.

Supply Chain Issues: There have been instances of counterfeit drugs and substandard raw materials entering the supply chain, leading to quality issues in the final products. For example, according to The US Trade Representative (USTR) report, nearly 20% of all pharmaceutical goods sold in the Indian market are counterfeit.  

Price Fixing: In 2018, the Competition Commission of India (CCI) imposed penalties on three pharmaceutical companies for allegedly fixing the prices of a certain drug. These irregularities have raised concerns about the safety and efficacy of drugs manufactured in India and highlighted the need for better regulatory oversight and enforcement.  

What are the challenges associated with drug regulation in India?  

Drug regulation in India faces several challenges, including:  

Lack of resources and infrastructure: India has a vast population, and the country’s drug regulatory system is often overburdened, with a shortage of staff, laboratories, and equipment. For example, India’s drug regulatory agency, CDSCO, faces resource constraints such as limited funding, inadequate staffing, and outdated infrastructure, which can make it difficult to effectively oversee drug safety and efficacy.  

Corruption: Corruption is a significant issue in India’s drug regulatory system, with reports of officials accepting bribes to approve drugs. In 2013, the Ranbaxy scandal exposed how the company had falsified data and received approvals for drugs that did not meet quality standards.  

Price Control: The Indian government regulates the prices of certain drugs to make them affordable for the general public, which can lead to conflicts with pharmaceutical companies. For example, in 2013, the Indian government allowed local companies to produce generic versions of a cancer drug that was under patent protection, leading to a legal dispute with the drug’s manufacturer.  

Delayed approval process: The approval process for drugs in India can be lengthy and cumbersome, with approvals taking years to obtain. For example, the approval process for the vaccine for the COVID-19 pandemic in India took longer than in other countries, leading to delays in vaccination efforts.  

Inadequate monitoring: The lack of a robust system for monitoring drug safety and efficacy is a significant challenge. This can lead to dangerous drugs being sold in the market, as was the case with the painkiller Nimesulide, which was banned in several countries but continued to be sold in India for years.  

Poor pharmacovigilance: Pharmacovigilance is the process of monitoring the safety of medicines once they are on the market. In India, the pharmacovigilance system is still developing, and there is a lack of awareness among healthcare professionals and patients about reporting adverse drug reactions (ADRs). For example, there have been reports of adverse reactions to the COVID-19 vaccine in India, but these have not been adequately investigated.  

Fragmented regulatory framework: India’s regulatory framework is fragmented between the central government and state governments, leading to varying levels of quality supervision and providing arbitrage opportunities. This has led to questions about the sampling methodology used in assessing drug quality.  

What should be done to resolve issues related to the drug regulatory system in India?  

Strengthening the regulatory framework: The government should strengthen the regulatory framework and enforce stricter laws to ensure that the drugs and medicines produced in India meet the required safety and quality standards.  

Increasing inspections and audits: Regular inspections and audits should be conducted at all levels of the pharmaceutical industry to identify and address any potential issues related to the manufacturing process, quality control, and distribution.  

Enhancing transparency and accountability: The government should promote transparency and accountability by making the regulatory process more accessible and understandable to the public and stakeholders. This can be done by improving the dissemination of information and conducting public consultations.  

Providing training and capacity building: The government should invest in training and capacity building for regulatory agencies and industry professionals to ensure that they have the necessary skills and knowledge to maintain high standards of drug quality and safety.  

Collaboration with International Bodies: India should collaborate with international bodies like the World Health Organization (WHO) to adopt best practices in drug regulation. This will help ensure that Indian pharmaceutical companies are following global safety and quality standards. The authorities should also work closely with international bodies to monitor the safety of drugs that are exported from India to other countries.  

Development of a robust pharmacovigilance system: The government can invest in the development of a robust pharmacovigilance system to monitor adverse drug reactions and prevent any potential harm to patients.  

Sources:  The Times of India, Outlook, The Quint, The Diplomat, The Hindustan Times, Financial Express, Decan Herald and Economic Times.

Syllabus: GS 3: Economic development – Changes in industrial policy and their effects on industrial growth.