Indian court upholds government order to include bar codes on drugs and devices

BMJ 2013; 346 doi: (Published 24 January 2013) Cite this as: BMJ 2013;346:f473
  1. Meera Kay
  1. 1Bangalore

The High Court in Chennai has upheld packaging rules introduced two years ago for curbing the export of counterfeit pharmaceutical products and medical devices.

Bar codes were made mandatory for drugs and medical devices in phases from 10 January 2011, with all products requiring them by October that year. They are required on blister packs, vials, and bottles and provide a unique product identification code, batch number, expiry date, and serial number. Similar details are also required on any further packaging.

However, the Confederation of Indian Pharmaceutical Industry and the Indian Drug Manufacturers’ Association challenged the rules in court, arguing that the changes would incur very high costs. Foreign buyers of Indian drugs would have to pay a higher price and so may find alternative suppliers in countries with cheaper production, such as China, they said.

However, the High Court agreed with the government that bar codes improved the ability to track and trace products, needed to protect the country’s trade reputation.

Delivering its judgment in the case, which had been pending for more than a year, the court said that it did not accept the industry’s argument on cost, noting that no cost is too much where quality is concerned.

Industry experts said that India is the world leader in the generic drug market, exporting over $10bn of products annually to more than 100 countries. With several patented drugs going off patent in 2012, Indian manufacturers are keen to maintain their market share as a key supplier to the United States, Europe, and emerging markets.


Cite this as: BMJ 2013;346:f473