India delays barcoding initiative after High Court challenge

Rumours of a six-month delay in India's barcoding plans for exported medicines were confirmed today by the Directorate General of Foreign Trade (DGFT).

While plans for barcoding for tertiary packaging (e.g. shippers and cartons) will go ahead as planned, the DGFT has confirmed that the deadlines for secondary level packaging has been set back to July 1, 2012 and primary packaging to January 1, 2013.

The deadlines for secondary and primary packaging were previously January 1, 2012, and July 1, 2012, respectively. The DGFT confirmed the delay in a public notice published today.

The DGFT's decision came after a High Court in Chennai ruled in favour of a joint petition - filed by the Confederation of Indian Pharmaceutical Industries (CIPI) and Indian Drugs Manufacturers Association (IDMA) - which asked for a stay on the barcoding implementation.

It is understood that almost all the pharmaceutical companies in India have complied with barcode requirements at tertiary level packaging, and this element was not mentioned in the petition.

However, many companies have said they would be unable to meet the original deadlines for secondary and primary barcoding, and there were concerns that the short timeframe would be particularly hard for small and medium-sized enterprises (SMEs) to meet.

With India providing a phenomenal proportion of the world's generic medicines - particularly to developing markets - there have also been concerns that access to essential medicines could suffer as a result of the initiative.

A source close to the Indian Ministry of Commerce told SecuringPharma that after looking at the petition, the Chennai High Court ordered the DGFT to maintain the status quo.

From a jurisdictional perspective the implication of this order is not restricted to only Chennai or Tamilnadu State, but would be applicable throughout India, according to the source.

The DGFT first adopted the barcoding scheme to help restore India's reputation as a quality medicines provider in the wake of allegations that it was a source of counterfeit and substandard drugs.