The domestic drug industry has expressed serious concern over the central government's decision to make it mandatory to carry a barcode on every medicine pack meant for exports from July 1. The industry fears the new rules, if followed without change, will cause delay in export consignments. India exported medicines worth Rs 42,000 crore (Rs 420 billion) to over 100 countries last year.
The public notice announcing the change was issued by the Directorate General of Foreign Trade last week.
What worries the industry is the blanket requirement for barcoding on all packs - right from an ampule or tablet strip to the wholesale cartons - as that would require fresh labelling approvals from all drug regulators where the medicines are exported to.
The industry also feels the time allowed to comply with the new norms is too little, as it would involve additional investments in machinery, an issue pointed out by small, medium scale and merchant exporters.
Incidentally, the suggestion to introduce barcoding as a solution to ensure the quality and traceability of medicines originating from India was mooted by the industry itself.
However, the scope and timing were not to their comfort, it is learnt.
According to government officials, the decision will help Indian industry in a very big way, as it will create confidence among the buyers and buyer countries.
"We welcome the decision. However, we need more time to comply with the requirements," Indian Drug Manufacturers' Association Secretary General Daara Patel said.
The industry leaders are meeting this week to take stock of the situation and express their views to the ministry.
According to industry representatives, the labelling approvals may take six months to one year, depending on the drug regulatory system in each export destinations.
The decision will also affect merchant exporters, who constitute 30 per cent of the total registered drug exporters in the country, as they will have to get their vendors carry out these changes.
The move will also put an end to the current practice among some merchant exporters to source medicines from the retail market, as barcoding is not required for domestic supplies.
"Barcoding should be limited to a select number of countries to begin with. There should also be financial assistance to support the small exporters," an industry official said.
India decided to make barcode mandatory for medicine exports after some African countries alleged that some of the counterfeit medicines seized by them were from India.
Though it was later found that the consignments in question did not originate from India, the ministry decided to plug all loopholes by introducing a new system to trace the medicine to its place of origin.
