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The concerns surrounding the quality of pharmaceutical products in India are not new, nor are they isolated incidents that can be dismissed as aberrations. Over the years, several quality-related issues have surfaced with alarming drug regularity and demanding the urgent attention of regulators, drug manufacturing companies, and the healthcare practitioners alike.
India carries the epithet “the pharmacy of the world” due to its leading role in manufacturing affordable and quality generic medicines for global consumption. However, this prestigious title also comes with an inherent sense of accountability. Each failure, each reported incident of substandard or adulterated medicine, chips away at the trust that the world has placed in India’s pharmaceutical capabilities.
The recent cough syrup tragedy in MP, where 24 children lost their lives after consuming adulterated cough syrup, has once again brought the matter to the forefront. It is easy, and perhaps convenient, to shift blame to specific stakeholders - be it the central regulatory authority, state regulators, manufacturers, traders, practitioners, or the supply chain. But such incidents raise a deeper question: should accountability be limited to one entity? In reality, the pharmaceutical ecosystem involves multiple interconnected layers, and ensuring drug safety requires a sense of collective responsibility across all of them.
In recent years, several high-profile cases have pushed the Indian pharmaceutical industry into an unflattering global spotlight. Broadly, Indian pharmaceutical operates in three types of pharmaceutical markets: the domestic market, exports to stringently regulated markets (such as the United States, the European Union, and Japan), and exports to less stringently regulated markets.
Most cough syrup tragedies have a common thread: contamination of excipients such as propylene glycol or glycerin with ethylene glycol. These industrial-grade impurities are highly toxic and pose serious health risks, especially to children. India has recorded at least five major propylene glycol poisoning incidents since 1972, with the first occurring in Madras. On the other hand, the United States experienced a similar catastrophe once - the infamous “Elixir Sulfanilamide tragedy” of 1937. That single event led to a sweeping overhaul of American drug regulation and the enactment of the Federal Food, Drug, and Cosmetic Act (1938). Remarkably, no comparable incident has occurred there since. This contrast forces us to reflect: why have we failed to learn from repeated tragedies?
Each such event in India triggers a predictable chain reaction: blame is assigned, culprits are identified, arrests are made, and corrective actions are announced. But do these responses address the underlying systemic issues? Are we truly strengthening our drug regulatory framework?
Year after year, the Central Drugs Standard Control Organisation publishes lists of Not of Standard Quality drugs on its website. Since 2019, a searchable database has also been made available. The breadth of Not of Standard Quality drug reports is concerning - ranging across dosage forms (oral, parenteral, and topical) and therapeutic categories. Issues include sterility failures, incorrect assays, out-of-specification dissolution profiles, presence of impurities, and even labelling discrepancies. If such a wide spectrum of failures continues to emerge regularly, it begs the question: are we genuinely learning from past mistakes, or merely reacting to crises?
Another systemic challenge lies in the storage and distribution of pharmaceutical products. India’s geographical diversity results in extreme fluctuations in temperature, humidity, and environmental conditions - from the freezing Himalayan regions to scorching plains touching 50°C, and from humid coastal zones to arid drylands. Despite this, most stability studies used to determine a product’s shelf life are based on a standard temperature of 30°C. When medicines are transported or stored outside recommended conditions - often without adequate cold chain facilities - their safety, stability, and efficacy may be compromised. Strengthening temperature-controlled logistics is no longer optional; it is an imperative.
The role of pharmaceutical marketing practices also merits scrutiny. Many companies lure healthcare providers, retailers, or distributors by offering high margins or incentives. While practitioners and chemists may not have the scientific tools to independently verify product quality, they are often aware - at least indirectly - of the reputation and reliability of manufacturers. When smaller or lesser-known companies offer disproportionately high profits, especially on pediatric medicines, decision-making should be guided by ethical responsibility rather than financial temptation.
Another layer of complexity is added by India’s unique position as a country with a parallel system of traditional medicine - Ayush (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy). Ayush formulations are widely consumed domestically and exported internationally also, but their regulatory oversight remains less stringent than that of allopathic pharmaceuticals. Like, in the year 2009 the Department of Ayush (Now Ministry of Ayush) vide G. S. R. 764 (E) dated 15th Oct. 2009 incorporated the Rule no. 161-B referring to the shelf life or expiry date of the ASU medicine, in the Drugs and Cosmetic Act 1940 and Rules made there under, which was further revised vide G. S. R. No. 789(E), dated 12th August, 2016 by the Ministry of Ayush and amended the Rule No. 161-B of D&C Act 1940 and Rules 1945, applicable for the rules for shelf life or expiry date of the products. But still there are companies/products which claim the shelf life through literature support, not through the actual recommended stability studies. The controversies surrounding products like Coronil during the Covid-19 pandemic highlight the regulatory gaps. The Delhi High Court eventually termed Coronil’s Covid-19 cure claims as “unsubstantiated” and “mischievous.” Fortunately, Ayush exports currently represent a relatively small market share and are often categorized as non-therapeutic products (e.g., nutraceuticals, dietary supplements or botanicals), which is why these issues have not attracted the same global scrutiny as allopathic drug failures.
Conclusion
India’s pharmaceutical sector stands at a crucial crossroads. The country has immense manufacturing capacity, technical expertise, and global trust - but these strengths can quickly erode if quality lapses continue. Ensuring drug safety requires a holistic strengthening of the ecosystem: robust regulations, sufficient and well-trained workforce, ethical manufacturing and marketing practices, improved logistics, and stringent oversight across all categories of medicine, including Ayush. Instead of reacting to tragedies, the country must move toward a proactive, prevention-driven regulatory culture. Only then can the nation truly uphold its title as the pharmacy of the world - in both scale and quality.
(Author is a New Delhi-based academician and R&D consultant, having working experience of global healthcare companies)
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