While the government seems adamant on sticking to its stated deadline on bar-coding on secondary packaging atleast for now, the drugmakers instead of treating the extension breather as a respite are fuming about the new deadlines. That is because the industry feels the government has no right to set new deadlines for mandating the technology at a time when the matter is sub-judice.
The Indian Drug Manufacturers Association (IDMA), an industry association of drugmakers has challenged the government on the issue in Chennai High Court. The case has been going on for the last three months in Chennai High Court. However, we want to implement secondary level barcoding from January 2013 because this will make our pharma exports more competitive in the global market, said a commerce department official. This has not gone down well with a section of industry, particularly the medium and small-sized pharma companies.
How can the government set up new deadlines for mandating track and trace technology on secondary and primary packaging of export consignment at a time when the courts are still considering the core of the matter Our lawyers are drafting a letter seeking explanation from the government for its action at a time when the matter is subjudice, said Daara Patel, secretary general, IDMA.
Under the first phase, trace and track technology has already been made compulsory for tertiary level packaging as part of which a unique barcode has to be affixed on cartons which helps in tracking and tracing of origin of drugs thereby minimising the chances of genuine generic drugs getting labeled as spurious or counterfeit. The second phase involves barcoding on packets of medicines while the next phase entails barcoding on primary packaging such as blisters, vials or bottles. Last year when government seemed determined to impose barcoding on all forms of packaging in one go, IDMA had demanded a clear exclusion of primary packing material such as bottle, blister and vial from barcoding. The text matter on the label of each strip or vial has to be approved by the individual importing country. So, changes would first have to be approved by the regulator of importing countries, an IDMA representation to ministry in addition to protesting about the cost increases involved which may render exports from India less attractive.
Ministry of commerce though, maintain that the step would put at rest all baseless speculation of India being a source of spurious drugs and build a formidable reputation of the countrys drug industry.