Regulator lens on blurry or tucked away medicine label details

The move by the Central Drugs Standard Control Organisation (CDSCO) aims to curb medication errors and improve patient safety in India's $50 billion pharmaceuticals market.

According to the plan in the works, the CDSCO and state regulators will step up plant inspections and issue targeted instructions to drug inspectors with a focus on visibility, durability and placement of key information.

Following complaints, the apex regulator had appointed a committee that identified a significant gap in the variability of medicine labelling implementation at the manufacturing level.

Consumers' complaints ranged from the packaging information being illegible due to a host of reasons to the demand for the medicine name being printed across the package and for a universally-recognized symbol on generic medicines to distinguish them from branded ones.

The CDSCO set up a sub-committee in July 2025, chaired by the drugs controller of Telangana, with drugs controllers of Kerala, Odisha and representatives of HLL Lifecare Ltd, the deputy drugs controller of Hyderabad zone and Indian Drug Manufacturers’ Association (IDMA) officials as members.

In its report, this panel said the CDSCO and state licensing authorities "may issue suitable advisories or internal instructions to GMP inspectors to ensure focused scrutiny of labelling practices, including visibility, durability and placement of expiry date, batch number and drug name during routine inspections”.

“Manufacturers may be encouraged to voluntarily adopt improved packaging and printing practices, consistent with existing rules, wherever feasible, to enhance consumer readability without mandating rigid technical specifications,” it said.

Queries emailed to the health and family welfare ministry and the Drugs Controller General of India on 11 April remained unanswered until press time.

India's pharmaceutical industry is ranked third globally by volume and 14th by value, and it supplies 20% of the world's generic medicines and 60% of the vaccines to over 200 countries.

Pharmaceutical companies admit there is a variance in labelling practices across manufacturers.

“In practice, there is still variability across manufacturers in font size, contrast, and the use of glossy or reflective surfaces, which can impact readability," said Soumyanath Mishra, head of packaging research and development at Mankind Pharma. “As a responsible manufacturer, we ensure expiry dates and batch numbers are printed in clear, legible fonts with sufficient size and high contrast. Critical information is placed in multiple visible locations (on strip/carton) so it remains readable even if one pack component is damaged or separated.”

The government has been going all out to better regulate the pharmaceutical industry. Mint had earlier reported on the plan to publicly disclose the findings and recommendations of inspections conducted on drug manufacturing facilities.

Hari Kiran Chereddi, the managing director and chief executive of Hyderabad-based HRV Pharma said companies must “proactively raise the bar on printing quality and placement to ensure consumer readability. This has to be a matter of pride, not just a mere tick in the box”.

Health experts say clear drug labelling is a critical patient safety intervention. Dr. Aashish Chaudhry, managing director of Delhi-based Aakash Healthcare said non-compliance increases the risk of medication errors, misuse, and adverse outcomes. “In a country like India, where medicines often pass through multiple hands before reaching the patient, durable and prominently printed labels are essential to ensure safe, informed use at every step,” he said.