Why the drug regulator is looking to redesign medicine labels

India’s top drug regulator is stepping in to change that. The Drug Controller General of India (DCGI) is working on a nationwide overhaul of medicine packaging and labelling norms. 

The goal is to make expiry dates and batch numbers easier to read, reduce confusion between generic and branded drugs, and help patients, make better-informed choices, two government officials aware of the matter said.

As part of the proposed changes, manufacturers may soon be required to use larger fonts, ditch shiny packaging that reflects light and obscures print, and print expiry dates in more than one place to prevent vital information from being torn off. 

There’s also a plan to introduce a universal symbol to clearly distinguish generic medicines from branded ones. The regulator had received several complaints regarding the difficulty in differentiating between cheaper generic drugs and their branded counterparts, and consequently, the pricing comparison.

“The drug regulator has received various complaints and demands from the consumers regarding the labelling of medicinal products such as tiny font size of the letters printed on the drug packaging, shiny labels, the expiry date of the medicines getting torn while taking out the medicine, and demand for universally recognised symbol on the generic medicines that will distinguish it from the branded medicines,” said one of the officials cited above requesting anonymity.

A sub-committee, set up by the DCGI, is reviewing the proposals and is expected to submit its report soon, the second official said. The committee is also examining ways to incorporate these changes under the Drugs and Cosmetics Rules, 1945, which governs the quality of drugs manufactured, imported, and sold in the country.

Queries sent to the health ministry on Monday and DCGI spokesperson on Tuesday remained unanswered till press time.

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Branded vs generic

While both generic and branded medicines contain the same active ingredient and are expected to have the same therapeutic effect, their key differences lie in cost, brand recognition, and patent status.

Branded medicines such as a well-known painkiller, often carry a higher price tag due to the research, development, and extensive marketing by the innovator company. Generic medicines, on the other hand, are typically much cheaper (often 80-85% less) because they are manufactured after the original drug’s patent expires, eliminating the need for costly R&D and marketing.

For instance, if ‘PainRelief Pro’ is a popular branded drug for headaches, its generic equivalent, say ‘Paracetamol 500mg’, will offer the same relief at a fraction of the cost.

But customers often miss this. They ask for affordable, quality medicines but are often unaware of generic alternatives, said Rajiv Singhal, president and General Secretary of the All India Organization of Chemists and Druggists (AIOCD) representing 1.2 million members in the country.

He called for expiry and batch details to be printed in clearer, larger fonts in multiple places to prevent accidental torn off.

“If this regulation comes into play, companies will have to mandatorily follow,” he said, emphasizing the importance of regulatory enforcement.

The development assumes significance given that India holds the distinction of being the world’s largest supplier of generic drugs, accounting for approximately 20% of the global supply and manufacturing around 60,000 generic brands across 60 therapeutic categories.

Mint had earlier reported that DCGI was considering Braille labelling on drug packaging to support the 4.95 million blind and 70 million visually impaired people in India.

Global standards

Globally, drug labels tend to be much simpler. Dr. Viranchi Shah, national spokesperson for the Indian Drugs Manufacturers Association (IDMA), said Indian medicine strips are detailed compared to their international counterparts. 

For example, international labels often only state the tablet’s name, omitting details like coating information or the explicit phrase “to be sold on the prescription of registered medical practitioners.” Instead, the “Rx” symbol is commonly used to indicate a prescription requirement, with its absence signifying an over-the-counter (OTC) drug.

The extensive information and specific font size requirements on Indian labels are seen as cumbersome, leading to substantial inventory costs and a significant financial burden on companies for redesigning packaging, Shah said.

He said that the industry is open to changes for the greater good and informed that IDMA had previously submitted its representation to the DCGI years ago, suggesting simplified labelling. 

He said that a key hurdle to such changes is the significant inventory held by pharmaceutical companies. Changes to labelling would require a phased approach to avoid disruption.

“Any future changes, whenever and however implemented, should consider suggestions from both patients and the industry, and be introduced in a phased manner to minimize disruption.”

This step will empower patients and enhance transparency in the Indian pharmaceutical market, said Nikkhil K. Masurkar, CEO, Entod Pharmaceuticals. The current lack of visual cues on packaging, he said, often leaves patients unaware of generic alternatives.

The government’s Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) may also benefit from the labelling overhaul. PMBJP operates over 17,000 Janaushadhi Kendras across India to offer quality generic medicines at affordable rates.

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India’s pharmaceutical market, meanwhile, continues to expand. According to Pharmarack, the Indian Pharmaceutical Market (IPM) reached ₹19,720 crore in sales for May 2025, showing a 7.2% YoY growth. On a moving annual total (MAT) basis, the industry posted ₹2.29 trillion, reflecting an 8.1% annual growth and 9.8% CAGR.

While pharma companies may face some logistical costs in updating their packaging, the industry believes these are manageable and worth the impact on patient safety, affordability, and transparency.