Last Updated:
The move aims to boost transparency, strengthen patient safety and push companies towards higher-quality standards
The union health ministry has amended the Drugs Rules, 1945, to make it mandatory for pharmaceutical companies to disclose the qualitative details of excipients—the so-called inactive ingredients that support the main drug compound—on labels of medicines. Representational image
Soon, scanning the QR code on your bottle of cough syrup will not just tell you the drug’s details but also reveal the quality of sugar, preservatives, and colours that went into it—information that, until now, was never shared with patients.
Not only cough syrup, but all 300 medicines falling under Schedule H2 will now carry details of all products used during manufacturing.
Recommended Stories
What are excipients?
The union health ministry has amended the Drugs Rules, 1945, to make it mandatory for pharmaceutical companies to disclose the qualitative details of excipients—the so-called inactive ingredients that support the main drug compound—on labels of medicines. The provision will apply to Schedule H2 drugs, which include the top 300 brands in the Indian market, and will come into effect on March 1, 2026.
These 300 drugs—which include the country’s top-selling brands such as Allegra, Dolo, Augmentin, Saridon, Calpol, and Thyronorm, among others—already carry mandatory QR codes. Once the new rule comes into effect, scanning the QR code will open the complete quality profile of the formulation, including the grade of excipients used.
The move aims to boost transparency, strengthen patient safety, and push companies towards higher-quality standards.
“The move will allow doctors, patients, and regulators to look beyond the bulk drug (main therapeutic compound) and understand the quality of additives,” a senior government official requesting anonymity told News18 while adding that “the step brings transparency where all stakeholders would know how the drug has been made and what is the quality of ingredients used.”
How is the move beneficial?
A drug typically contains two components: the active pharmaceutical ingredient (API), which produces the therapeutic effect, and the excipients, which act as stabilisers, fillers, sweeteners, or colouring agents.
For instance, in Crocin, paracetamol is an API, but a pill cannot be made only by using the main therapeutic agent. Hence, many other additives are used, known as excipients.
While excipients are not responsible for curing illness, their quality affects how safe and tolerable a medicine is, and in some cases may trigger allergic reactions.
The change follows deliberations within the health ministry after patients raised concerns over excipients such as parabens, commonly used as preservatives, which can trigger allergic reactions. The issue was flagged before the Drugs Technical Advisory Board (DTAB), which noted that medicine strips in retail shops currently carry no clear indication of excipient composition, making it difficult for patients to find paraben-free formulations, including common drugs like antihypertensives.
While earlier discussions within the Drugs Consultative Committee (DCC) explored whether details could be included in package inserts or on every strip, regulators pointed out that package inserts are not mandatory and that listing all excipients may not be practical. After a detailed debate, DTAB, in its January 25, 2024, meeting, recommended capturing excipient details through QR codes for the top 300 drug brands, a proposal that has now been formalised through this amendment.
About the Author
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass…Read More
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective. She is particularly pass… Read More
Loading comments…
Read More
