Rethinking Drug Regulation In India: Strengthening Oversight To Ensure Patient Safety

Contaminated drugs | Representative image | The Probe

The Indian pharmaceutical industry has recently been making headlines for all the wrong reasons. A few days ago, the World Health Organization (WHO) investigated the global distribution of contaminated cough syrups. During the investigation, seven products manufactured in India were identified as a cause for concern. In total, the WHO investigation revealed twenty toxic medications that led to over 200 deaths worldwide.

Prof. Bejon Kumar Misra, founder of the Patient Safety & Access Initiative of India Foundation (PSAIIF) and a consumer policy expert, speaks to The Probe’s Pragynesh. 

In response to the findings and concerns raised by the WHO, India's health ministry stated that India follows a zero-tolerance policy on the production and distribution of counterfeit medicines. The country's drug regulator has initiated a crackdown on manufacturers involved in the production of spurious medicines. However, these efforts are belated and come at a time when the consumption of contaminated drugs has already resulted in a significant public health concern both in India and abroad.

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In November of last year, an Indian company that produced a cough syrup came under scrutiny when Gambian authorities claimed it was responsible for the deaths of children in their country. Following this incident, there were further reports in December linking Indian cough syrups to the deaths of children in Uzbekistan. More recently, the US Food and Drug Administration (FDA) issued a warning advising consumers against purchasing and immediately discontinuing the use of a specific brand of eye drops manufactured in India due to potential bacterial contamination.

However, in most of these cases, both the Indian government and the country's drug regulator, Central Drugs Standard Control Organisation (CDSCO), have refuted allegations of contamination even before investigations could take place. This approach has drawn criticism, as the government is being accused of treating a public health concern as a public relations issue.

Dr Gopal Dabade, President of Drug Action Forum and Convener of All India Drug Action Network, states, "The government cannot conceal itself behind denials. When the World Health Organization (WHO) acknowledges problems, the government must turn its gaze inward instead of shifting blame onto others. The government needs to take a look at its regulatory mechanism where we are lacking. Additionally, it is crucial to address the issue of political interference in the regulatory authority. The government also must look at the Lentin Commission report that provides compelling evidence in favour of establishing a highly robust regulatory authority in India and the need for accountability in drug testing and control".

In August 2003, the Mashelkar Committee recommended that manufacturers of spurious medicines causing deaths should be subject to the death penalty. But according to the latest rules, the maximum punishment for such crimes is between three and five years, along with a mere 10000 rupee fine. Prof. Bejon Kumar Misra, the founder of the Patient Safety & Access Initiative of India Foundation (PSAIIF) and a consumer policy expert, served as a member of the Mashelkar Committee. According to him, the committee made several significant recommendations to revamp India’s drug regulatory system. However, these recommendations have been neglected and remain unimplemented, gathering dust over the years.

“I was a member of the Mashelkar Committee representing the patients and consumers. It was an immensely valuable report, and the committee’s work was commendable. The committee was formed during the tenure of Atal Bihari Vajpayee. Our primary objective was to ensure that individuals who produce counterfeit drugs and endanger the lives of citizens should face severe consequences. We advocated for the imposition of the death penalty on such criminals due to the significant public health concerns caused by their actions. Unfortunately, subsequent governments failed to implement this recommendation. It is disheartening to witness important reports and recommendations like ours being neglected and left untouched. These reports are packed with valuable information, and it saddens me to think about the resources invested in this process when they are simply disregarded. It brings tears to our eyes. The current administration has undertaken various initiatives, but it is crucial to first address the loopholes in our regulatory system and rebuild citizens’ trust in the drugs manufactured in India,” explains Prof. Mishra.

Prof. Misra states that India has a reputation for being a prominent pharmaceutical hub. India’s pharmaceutical exports exceed domestic consumption, accounting for over 50% of total production. However, he says that the importing countries must also have their mechanism in place to check spurious drugs.

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“Certain importing countries, like Gambia in this case, have been compromising on quality and neglecting to prioritise the quality of drugs imported from reliable sources in different nations. In contrast, India has gained recognition for producing high-quality medicines at affordable prices for global consumers and is often called as the pharmacy of the world. When substandard drug incidents occur, competing pharmaceutical markets may attempt to tarnish India’s image. Nevertheless, there is the presence of criminals in every country that operate against the interest of public health, and India’s supply chain must be shielded from such elements,” asserts Prof. Misra.

According to Prof. Misra, the regulatory mechanism in India currently operates more reactively, akin to a fire brigade that springs into action upon receiving an alarm. “This approach to acting only when there is an alarming situation must stop. Why all this crackdown now? It should be a continuous process. Regulators should proactively conduct surveillance, perform regular audits, and establish robust systems to prevent such instances from arising in the first place.” 

Dr D Roy, former Deputy Drugs Controller General of India, notes that it is important not to get carried away by criticism but instead examine the facts of each case. “During my tenure, the Nigerian government lodged a complaint alleging that India was supplying substandard drugs. I thoroughly investigated the matter and challenged their claim, requesting them to provide us with samples. Upon examining the samples, it was discovered that these drugs were smuggled goods procured through illicit channels from various other countries. So, when a country accuses India, verifying whether the samples originated from within our country is very important. It is crucial to understand that not all claims are true, and I can tell you this based on my experience,” affirms Dr Roy.

Understanding consumption patterns is another crucial aspect when addressing the issue of spurious medicines and ensuring public health and safety. Prof. Dr Nirmal K Ganguly, former Director General of the Indian Council of Medical Research (ICMR), emphasises the significance of considering consumption patterns alongside quality regulations. 

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“It is essential to examine not only the quality of medications but also the manner in which they are consumed. Some individuals are administered medicines in excessive amounts, and in some other cases, some individuals consume medicines in excessive amounts. How does one regulate that? While the regulatory bodies in India are actively investigating numerous cases and implementing necessary adjustments, it is crucial to focus not only on the quality aspect but also on examining consumption patterns from a regulatory standpoint,” says Prof. Ganguly. 

India’s current drug regulatory mechanism is in dire need of a comprehensive overhaul. The prevalence of counterfeit and low-quality medicines not only puts patients at risk but also tarnishes India’s reputation as a reliable global supplier of pharmaceutical products. “Every country needs a robust regulatory mechanism in place for drugs. If drugs fail, it implies that the regulatory authorities have failed. This is not the first instance where India’s drug regulatory authorities have fallen short. We must understand that drug companies often attract top talent due to their substantial financial resources. Hence, it is crucial for the drug regulatory authorities to stay updated and adequately equipped to ensure they can effectively compete with these companies. Each regulatory officer should provide a conflict of interest letter to the relevant authorities as significant forces are at play within the pharma industry,” notes Dr Dabade.

Moreover, the complex and dynamic nature of the pharmaceutical industry necessitates a regulatory framework that keeps pace with technological advancements, evolving market dynamics, and emerging challenges. The current system, often criticised for being reactive rather than proactive, requires a fundamental shift towards a more proactive and vigilant approach.

“The processes and systems currently in place are not user-friendly and do not prioritise consumer interests. We require evidence-based mechanisms that prioritise safety and effectiveness. An effective system for drug recalls needs to be established, ensuring that faulty drugs are identified and recalled before reaching consumers’ homes. It is imperative to have such systems in place that can effectively address glaring loopholes even after a drug has entered the market. Around 2014-15, the Indian government conducted one of the world’s largest studies on the quality of drugs within the supply chain. This survey generated valuable recommendations; however, these recommendations have been left unimplemented and are gathering dust as in the case of many other reports,” states Prof. Misra.

The Central Drugs Standard Control Organisation (CDSCO) confronts significant challenges, including inadequate resources, ineffective implementation of existing regulations, conflicts of interest, and a deficient surveillance mechanism. Additionally, the CDSCO has faced criticism for its ineffective pharmacovigilance practices. As the regulatory authority responsible for setting standards and providing guidance to state regulators, the CDSCO encounters multiple obstacles in its operations. One major issue is the lack of coordination among states, leading to instances where drugs that have failed quality tests in one state continue to be sold in others. This poor coordination, combined with the CDSCO's inefficiency as a central regulator, contributes to a suboptimal state of affairs in drug regulation. In order to bring about significant changes, the existing condition necessitates a comprehensive overhaul of India's regulatory body. Mere incremental changes would prove inadequate; instead, a complete restructuring of the drug regulator is the need of the hour.