The Commerce Ministry. Has made it mandatory for pharma companies to bar code medicine strips effective October 1st. Also the medicine strips and containers will be expected to have a “parent-child” relationship. This means that a bar-code will ensure that every unique strip of drug will go into a unique secondary package (containing the primary pack of drugs with safety instructions etc). The aim is to track the origins of a shipment and to curb the distribution of spurious drugs.
While the intentions are good, it will hit hard the nearly 1,000 small and medium-sized pharmaceutical companies, which account for 40 per cent of India’s total drug exports small pharma manufacturers, according to them. SMEs allege a conspiracy at play, with the export promotion council siding with multinational pharmaceutical companies to elbow out smaller generic drug makers.
“We already have bar-codes on secondary and tertiary packages. Small and Medium-sized Enterprises (SMEs) don’t have the money to establish parent-child relationships between strips of drugs and their packets. More importantly, it adds no value to the quality of the product,” said Bharat R. Desai, Chairman of the Indian Drug Manufacturers’ Association (IDMA) in Gujarat.
According to Pharmexcil, total exports by SMEs in India amount to approximately Rs. 20,000 crore. Between 10,000 and 15,000 people work in the 1,000 SMEs, which will be affected by the new bar-coding rules.
With the “parent-child” bar-coding coming into force, SMEs’ exports – which largely go to Latin American and African countries – will be severely affected, warned another IDMA member.
“What we are currently exporting was made in the previous month. The October labels cannot have parent-child bar-coding as we do not have Rs.1.25 crore to invest in that technology. We will be wiped out if the Ministry does not reconsider this decision. We are appealing to the Ministry, but the situation is dire and we will have to shut down next month. Meanwhile, these markets will be open for the bigger pharmaceutical companies,” the second IDMA official added.
When contacted, Commerce Minister Nirmala Sitharaman said, “Our Ministry is neither interfering nor taking sides in the matter.”