Thursday, January 9, 2014

Clarification on importing country mandate

Clarification asked on the following: 
To our understanding Indian authorities have already implemented specific requirements for serialisation with respect to products which are exported. 

What are the exact requirements when a product is exported out of India to a country which has another regulation (e.g. France)? 

In the secondary packaging section of the guidelines released by GS1 India it states that:
In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the above requirement.

The questions are:
1) If the import country has only a requirement to serialize the secondary packaging, would the Indian requirement for primary and tertiary packaging still apply?
2) If the import country has only a requirement to mark the product with datamatrix with GTIN, batch, expiry but not serial number, do we have to print 2 datamatrix on the product (one to comply with the import country requirement and the second for the Indian requirement)? 

Clarification given by GS1 India:
As per the manual, If the importing country has any mandate on any levels of the packaging, then it can be followed. For rest of the levels DGFT mandate will apply.

Bijoy Peter

GS1 India

Tuesday, January 7, 2014

DCGI to take up matter of barcoding for primary packaging with Commerce Min, Pharmabiz

DCGI to take up matter of barcoding for primary packaging with Commerce Min

Joseph Alexander, New Delhi
Tuesday, January 07, 2014, 08:00 Hrs  [IST]
The Drug Controller General of India (DCGI) will take up with the Commerce Ministry the issue of barcoding for primary level packaging of pharmaceutical products which, the industry felt, would be virtually impossible for small products.

DCGI Dr G N Singh, in a recent interaction with the industry leaders, said he would along with the Pharmexcil take up the matter with the Commerce Ministry and the concerned group of ministers. He also asked the industry leaders to give a detailed representation in this regard so that he can convince with the Health Ministry also.

“Systems are made for the benefit of the industry. It there is a strong justification against a particular norm, the government was open to remove it,” he felt, while responding to the industry criticism that it would be practically impossible to fix bar codes on primary packaging.

The DCGI, who stressed that the government was working for systematic changes in the regulatory system, also said that he had identified some key issues like test license and fee structure and would meet the industry soon to take the inputs.

The Commerce Ministry had made compulsory implementation of the tertiary level barcoding on packaging from October 1, 2011 and secondary level barcoding for pharma exports from January 1, 2013. Though the barcoding for primary packaging was to be implemented from July 1, 2013, it had given one year extension and postponed the implementation till July 1, 2014.

Instead of another year of extension, now the industry was pressing for the abolition of the rule, taking into consideration the practical difficulties.

Backing the cause, Pharmexcil director general, Dr P V Appaji said the agency had been pursuing the issue for the industry and would again press upon the ministry to drop the proposal for primary packaging as desired by the industry.