India delays barcoding initiative after High Court challenge
Phil Taylor, 22-Dec-2011
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.
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