Indian Pharma Irregularities Point To Lack Of Drug Regulation Policies And Better Oversight

In early February, a Chennai-based pharmaceutical company suspended a line of eye-drop production being supplied in the US market after the country's health authorities alerted that it could be contaminated with a drug-resistant bacteria that has been linked to reports of permanent vision loss and one death from a bloodstream infection.

Last year in December, the Central Drugs Standard Control Organisation (CDSCO) initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to a cough syrup manufactured by Indian firm Marion Biotech. 

Similarly in October 2022,  the World Health Organization (WHO) released a medical product alert. Four products from  India-based Maiden Pharmaceuticals had been found to be contaminated with unacceptable amounts of diethylene glycol and ethylene glycol, both toxic to humans. 

In the recent past, India has been hit by some major pharma concerns. The world largely depends on Indian pharmaceutical industry but rising concerns over quality and lack of drug regulations policy leads to the question whether India is failing in its role.

How drug regulation works in India

“Drug regulation in India is a complex process managed by law, mainly the Drugs and Cosmetics Act of 1940, and by multiple ministries, including the Ministry of Health and Family Welfare,” notes the report The Working And Performance Of CDSCO And SDRAs, published by Thakur Foundation.

Under the law, the Central Drugs Standard Control Organisation (CDSCO) assigns the Drug Controller General of India (DCGI) the key to act as the regulatory head that must act under the advice of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). 

CDSCO operates through zonal offices spread across the country, which have designated roles in drug regulation, such as inspections, recalls, and market surveillance.

State Drug Regulatory Authorities (SDRAs), which are statutory bodies created under the Drugs and Cosmetics Act, 1940, regulate drug policies at the state level. Falling under the ambit of the respective Health Departments of each state, SDRAs are tasked with limited aspects of drug regulation. 

In a nutshell, the Drugs and Cosmetics Act of 1940 creates a web of regulatory authorities to govern the process at both the central and the state levels. And with the recent recurring incidents of irregularities in manufacturing, experts have apportioned these several cases with the lackadaisical implementation of drug regulation and a paucity of inadequate infrastructure and planning. 

In 2012, the Parliamentary Standing Committee on Health and Family Welfare came out with scathing observations on the lack of transparency in the regulator’s functioning. The committee recommended that CDSCO come up with a clear set of written guidelines on the selection process of experts with an emphasis on expertise in the area of drugs.

What ails the Indian drug regulation?

The Truth Pill: The Myth of Drug Regulation in India, a book authored by public health activist Dinesh S. Thakur and lawyer Prashant Reddy Thikkavarapu, has sought to focus attention on many of structural issues affecting India’s drug regulatory system. They refer to the instances of Indian pharmaceuticals and big companies often outsourcing their manufacturing to smaller units. This creates a bigger problem as the country lacks the resources to maintain a regular quality check on these products.

It is also said that the biggest impediment to improving the quality of pharmaceutical regulation is the existing legal and administrative structures of the Central Drugs Standard Control Organisation (CDSCO). Unlike other regulators like the Telecom Regulatory Authority of India (TRAI) and the Food Safety and Standards Authority of India (FSSAI), the CDSCO does not have any statutory backing. 

Additionally, the poor regulatory system is also plagued by a lack of transparency and the complex distribution of regulatory powers across authorities without much oversight. There continues to be a lack of public databases on violations, inspections, and the history of a brand.

Proposals to improve the system

Last year in November, the Union government set up a seven-member high-level committee to prepare the first-of-its-kind 'National Drugs Database' in the country to provide comprehensive information about all drug formulations sold in India. The panel for the database has been constituted by the CDSCO under the Union Health and Family Welfare Ministry’s Directorate General of Health Services.

In February, Bharat Biotech’s Executive Chairman Dr Krishna Ella suggested that all state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation (CDSCO) to ensure “one quality one standard” for Indian drugs. His comments came against the backdrop of questions being raised about the quality of Indian drugs over the past few months.

Drugs, Medical Devices And Cosmetics Bill, 2022

To accommodate changing requirements and encourage the adoption of new technology, the Union Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. The proposed new law is called Draft Drugs, Medical Devices And Cosmetics Bill, 2022.

However, as much as this has been hailed as a significant step to bring about development in the space of Indian medicines and drug regulation, experts opine that it still leaves a gap for the lack of comprehensiveness. 

A policy advisory published by Takhshashila Institution points out that the Bill should ensure quality checks of food and supplements and the same should be brought out from the ambit of Food Safety and Standards Authority of India regulation into the scope of this Bill.

It is proposed that the Bill should have the scope for post-market adverse effect surveillance and ensure a system to look into public grievances, strengthening the rules for punishments for violating regulations. 

Among others, the policy advisory further says, “The Bill should treat drugs from Ayurveda, Siddha, Sowa Rigpa, Unani And Homoeopathic Drugs with the same scrutiny as applied for modern medicine drugs. A 10-year period can be given to the manufacturers to comply with this.”

Although India is proud of being the ‘pharmacy of the world’, it would be right to say that the drugs regulatory bodies and laws must take the spate of oft-warnings more seriously.