India has announced a six-month extension of its original deadlines for all drug products destined for export to carry mandatory barcoding.
The original requirement was for all primary-level packaging to be barcoded from July 1 2012, but this has now been extended to January 2013, while for secondary or intermediate medical packaging, the original deadline of January 2012 has been extended to July 1 2012, the government’s Directorate General of Foreign Trade (DGFT) announced this week.
“More time is being allowed,” said the DGFT in a public notice.
Industry groups had been urging the government for more time to comply with the requirements, and the new deadlines were announced this week after a High Court in Chennai ruled in favour of a petition filed by the Indian Drugs Manufacturers Association (IDMA) and the Confederation of Indian Pharmaceutical Industries (CIPI) calling for them to be extended. The Court’s ruling would be applicable throughout India, according to a report in Securing Pharma.
The IDMA has also called on the government to consider the barcoding initiative’s enormous regulatory, technical and cost implications for the industry and warned of the harm that these would do to India’s pharmaceutical exporters, particularly to small and medium-sized enterprises (SMEs).
IDMA president NR Munjal has proposed to Ministers that India should work towards the development of a worldwide track and trace system which includes a global barcode system, rather than pursuing a unilateral Indian system which may not be usable or acceptable by importing countries. Exports intended for these nations should be exempted from mandatory barcoding until the countries are able to accept the Indian system, he added.
Mr Munjal also pointed out that Indian drugmakers frequently produce on contract for overseas manufacturers, which do not require these products to be barcoded, so medicines manufactured in India under the label of a foreign company should also be exempt, he said.
In addition, the industry leader has called on the government to give serious consideration to providing financial assistance to help companies, especially SMEs, to cover the extra investment and costs needs to comply with the requirements. These extra burdens include a 20% productivity loss and increased monthly costs including 20,000 rupees in additional registration expenses and 100,000 rupees for barcoding accessories such as inks.
