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.