Bar-coding norm may hit 1,000 pharma companies

The battle for access to affordable Indian generic drugs has a new threat: bar-coding.

Pharmaceutical companies in India are expected to comply with mandatory bar-coding of medicine strips, as per directives of the Commerce Ministry. From October 1, 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).

*A bar-code will ensure that every strip of drug will go into a secondary package, containing the primary pack of drugs.
AIM: To track the origins of a shipment and to curb the distribution of spurious drugs.
*Small and medium-sized pharmaceutical companies (SMEs) claim they'll run out of business.
Allegations: SMEs allege a conspiracy at play, with the export promotion council siding with multinational pharmaceutical companies to elbow out smaller generic drug makers.

This measure is an attempt to track the origins of a shipment – to curb distribution of spurious drugs as those manufactured in India. But nearly 1,000 small and medium-sized pharmaceutical companies, which account for 40 per cent of India’s total drug exports – will be out of business if the domestic drug manufacturers’ lobby is to be believed.

‘Adds no value’

“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.

Further, SMEs allege a far deeper conspiracy at play, with the Commerce Ministry and Pharmexcil – the export promotion lobby – siding with multinational pharmaceutical companies to elbow out the smaller generic drug makers.

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.

According to papers reviewed by The Hindu, the Commerce Ministry had, in January 2014, reconstituted the Pharmexcil council to include ‘four government nominees’ and placed an entry barrier depending on the amount of drugs exported.

A senior member of the Pharmexcil council explains why this was important. “If I have to export a minimum of Rs.20 crore to have a say in Pharmexcil, only the big fish remain. Over the past year, the industry lobby group has entirely elbowed out representatives from SMEs. We have no voice anymore,” he said on condition of anonymity.

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.”

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Printable version | Jan 23, 2022 3:45:37 PM |

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