Last month India’s Central Government published a proposal for comment that, if enacted, would cause all drugs entering the Indian domestic supply to contain unique serial numbers encoded within 2D barcodes, and including aggregation and data reporting–all 180 days after publication of the final rule.
If you download the PDF, don’t be disappointed when you find that the first couple of pages are in Hindi. The full text is also included in English, starting on page 3.
RxTrace readers will recall that India currently requires serialization only of drugs manufactured for export, but not the domestic supply (see “India’s Pharma Export Regulations Update And The NECC Story” and see also “Ranbaxy, FDA, FDASIA and Indian Pharma Credibility“). This proposal is the first time I am aware that serialization and government reporting have been proposed for the India domestic supply chain.
By the way, according to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), India is the world’s 8th largest pharmaceutical market, consuming about US$15 Billion worth of drugs in 2013. India exported about US$11 Billion worth of drugs that same year. The export figure is growing fast but the domestic consumption actually shrank a little from 2012 to 2013.
This new publication was intended to result in the collection of comments about the proposal from the public and stakeholders. The 45-day comment window closes later this week so hopefully you had a chance to submit your thoughts to the Ministry of Health and Family Welfare.
The proposed provisions are very similar to the export rules as they existed on April Fools day this year. But on May 22, 2015 those export requirements were amended by India’s Directorate General of Foreign Trade (DGFT) with some very important relaxations (see “India’s Pharma Export Serialization Deadlines: April Fools!“). Unfortunately, those relaxations did not make it into this Ministry of Health proposal. Hopefully those who submitted comments brought up this discrepancy and explained the difficulty in attaining the provisions as stated in this new proposal in only 180 days!
Did your company submit comments about this proposal?