Shivanand Pandit
In the last week of September 2024, India’s Central Drugs Standard Control Organisation (CDSCO) published a troubling list of 50 popular and widely used medications. It includes some of the most commonly prescribed drugs for conditions like diabetes and hypertension, which were identified as either spurious or sub-standard (classified as Not Standard Quality or NSQ). The findings stemmed from random testing of these medications, conducted in various locations across the country. The CDSCO routinely releases monthly updates highlighting drugs that are spurious, NSQ, or misbranded. The 50 drugs included in this latest alert were flagged for August 2024. Historically, the CDSCO has documented a total of 263 such compilations over the years, underscoring ongoing concerns about the quality and safety of pharmaceuticals in the market.
Media reports indicate that Rajeev Raghuvanshi, the chief of CDCSO, disclosed that 36% of more than 400 inspected medium and small-scale drug manufacturing entities were shut down in the first half of this year due to inadequate facilities and poor-quality products. He also highlighted that 68% of the samples collected from these entities were found to be sub-standard. Raghuvanshi made these remarks in response to inquiries regarding reports connecting Indian-made cough syrups to the deaths of 300 children in three African nations.
India stands as the world’s third-largest manufacturer of drugs and pharmaceuticals by volume, trailing only behind the United States and China. Notably, it holds the title of the largest producer of generic medicines globally and is the foremost exporter of generic drugs and formulations. The country’s pharmaceutical sector plays a crucial role in supplying vital and life-saving medications to many poorer nations, particularly through its contentious compulsory licensing framework, which allows for the production of essential medicines at lower costs. In the previous year, India’s pharmaceutical exports reached nearly $28 billion, and projections indicate they could exceed $50 billion by 2030. This growth highlights India’s position as a significant provider of essential medicines, life-saving drugs, and vaccines—not only to the global commercial market but also in support of programs by the World Health Organization (WHO) aimed at improving health in many developing countries. With this substantial contribution to global health, India has earned the self-styled designation of the ‘pharmaceuticals capital of the world.’ However, this claim is complicated by ongoing concerns regarding the quality and safety of some pharmaceutical products manufactured in the country. The label ‘pharmaceuticals capital’ may be better suited to a more cautionary descriptor, such as the ‘spurious and substandard drug manufacturing capital of the world.’ Instances of counterfeit and low-quality drugs have emerged, raising serious questions about regulatory oversight within the industry. While India undoubtedly plays a pivotal role in the global pharmaceuticals landscape and provides critical access to affordable medicines, the persistent challenges regarding drug quality and manufacturing standards must be addressed. Only through stringent regulatory measures and improved manufacturing practices can India reinforce its reputation and fulfil its potential as a leader in the global pharmaceutical market.
However, this claim is complicated by ongoing concerns regarding the quality and safety of some pharmaceutical products manufactured in the country. The label ‘pharmaceuticals capital’ may be better suited to a more cautionary descriptor, such as the ‘spurious and substandard drug manufacturing capital of the world.’ Instances of counterfeit and low-quality drugs have emerged, raising serious questions about regulatory oversight within the industry. While India undoubtedly plays a pivotal role in the global pharmaceuticals landscape and provides critical access to affordable medicines, the persistent challenges regarding drug quality and manufacturing standards must be addressed. Only through stringent regulatory measures and improved manufacturing practices can India reinforce its reputation and fulfil its potential as a leader in the global pharmaceutical market.
The sector and regulators have let consumers down
Indian drugmakers have conveniently shifted responsibility for the current issues, blaming counterfeit drug manufacturers instead. In the latest testing, seven major pharma brands whose medicines were deemed substandard claimed that the tested samples were not produced by them. While this may be true, it’s important to recognize that many branded drugs are contract-manufactured by MSME entities. There has been no clear disclosure on how these large companies ensure quality, standards, and good manufacturing practices at their contract manufacturers’ facilities.
Are the major firms fully compliant? There has been a growing number of recalls of Made-in-India drugs exported to the U.S. due to substandard quality. India leads the world in receiving warning letters from the U.S. FDA for failing to meet Good Manufacturing Practices. Inspections by the FDA have uncovered alarming lapses and even falsification of test reports among several major Indian manufacturers. Interestingly, while Indian firms promptly respond to recall orders from the U.S. FDA, similar recalls for the same medicines sold locally in India are often not executed.
While increased surveillance by CDSCO may imply stricter regulation in India, the reality is quite different. The CDSCO relies on state drug control authorities, which are often understaffed, under-equipped, and underfunded to effectively address the scale of the problem. India lacks a mandatory drug recall law, despite proposals made years ago. Additionally, there is a prevailing belief at the policy level that reports highlighting poor quality in Indian-manufactured drugs are merely attempts by Western Big Pharma to undermine India’s growing exports.
While there is some truth to the notion that criticisms of Indian drug quality stem from trade tensions, it’s dangerous to dismiss all warnings as such. A 2017 World Bank report found that 10.5% of drugs sold in developing countries, including India, were substandard or counterfeit. Although India has rejected this figure, some surveys suggest a prevalence of around 3%, which, while better, is still significant. The public health implications of fake and substandard drugs are well-documented and harm India’s reputation as a reliable supplier of quality pharmaceuticals.
This issue requires ongoing monitoring and action. Last August, Health Minister Mansukh Mandaviya announced that Indian manufacturers had three months to comply with updated Good Manufacturing Practices, yet there has been no follow-up on compliance or penalties for non-compliance. To address these issues effectively, India’s regulatory framework must be strengthened, infrastructure improved—given that there are only about 47 drug testing facilities, with just 6 being central laboratories—and state regulators need better funding, staffing, and empowerment. Without these changes, the problem is likely to persist.
It’s time to take more decisive steps
The recent findings from theCDSCO raise serious concerns that cannot be dismissed as merely routine occurrences. States across India are required to submit lists of medicines that may be substandard or counterfeit; while Kerala has complied with this requirement as of August, other significant pharmaceutical manufacturing states like Telangana, Gujarat, Uttar Pradesh, and Maharashtra have yet to do so. Given the ongoing reports of various medicines being identified as substandard or fake over an extended period, both the government and the pharmaceutical industry must develop a comprehensive action plan to address these critical issues. Officials claiming that theNSQ drugs in question pose no significant threat to life are not acceptable. Any medication that has its strength misrepresented or is less potent than what is claimed can have severe consequences for patients. It is particularly alarming that commonly used medications are turning up with substantial quality issues. While it may be too early to conclude definitively that NSQs or counterfeit drugs are widespread, adopting a ‘zero tolerance’ approach is crucial.
According to the National Drug Survey conducted between 2014 and 2016, which tested over 47,000 samples, it was estimated that 3.16% of drugs were NSQ, with spurious drugs making up just 0.0245%. However, industry experts who have analysed CDSCO and state reports on NSQs over the past four years suggest that the percentage of NSQs is closer to about 4%. Alarmingly, recent submissions indicate that the actual proportion of counterfeit drugs might be higher than the survey’s findings, which is a significant risk to public health. Among the 53 defective drug samples identified, eight were classified as spurious, implying that the registered manufacturers were not accountable for these issues. Given this alarming situation, the industry and the government need to unite in tackling the problem of substandard and counterfeit drugs effectively. Industry bodies must take proactive measures to safeguard the reputation of a sector that boasts over 10,000 manufacturing units and a market valued at approximately $50 billion, which is experiencing double-digit growth.
In addressing the issue of NSQs, it is important to recognize that many identified cases are serious, often related to critical aspects such as product composition (assay), consistency (dissolution and disintegration), particulate matter, or pH levels. In instances where these quality concerns arise, product recalls must be executed swiftly and efficiently. A circular issued in August outlining ‘good manufacturing practices’ includes guidelines on recall procedures and the relevant laws; however, there is scepticism regarding the effective implementation of these provisions.Furthermore, the lists provided by CDSCO and the states should be more detailed, including information on sample sizes and the time and location of collection. It is ineffective to collect samples from distributors’ warehouses months after they have been dispatched from the factory, as this does little to resolve issues within the supply chain. Ultimately, the quality of medicines is a matter of life and death, underscoring the need for a balanced approach that combines appropriate regulation with the necessary freedoms for the industry to operate effectively.
