Even as the second phase of bar code implementation expected to become effective from January 1, 2012 under which bar coding on secondary level packaging of pharma exporting products becomes mandatory, an alarmed industry is once again knocking at the doors of the authorities. They want deferring of implementation on secondary level packaging as that will entail a string of regulatory, technical as well as cost issues which will only harm the pharma exporters in the country.
As the industry's repeated pleas to defer the implementation fell on the deaf ears of the union commerce ministry, the industry has once again turned to the Department of Pharmaceuticals (DoP) to take efforts to evolve a “Global Track and Tracealbility” programme using a harmonized bar coding system which will be acceptable lo all countries across the globe rather than impose a unilateral standard which may not be acceptable to the importing countries.
Asking the authorities to see reason, Indian Drug Manufacturers Association (IDMA) president NR Munjal in a letter to the DoP said that in countries which don't have any trace and track requirement, Indian trace and track guidelines can be implemented only after their acceptance of these guidelines. Till that time, products exported to such countries should be exempted from requirement of implementation of trace and track requirements.
Asking the authorities to examine the regulatory, technical and cost implications of the implementation of bar coding on secondary level packaging, Munjal in his letter said that regulatory approval required from each country for change of artwork to incorporate 2D barcode must be duly considered.
Regarding the technical issues involved in the implementation of bar coding, Munjal said that manufacturing in India is carried out on high speed machines giving very high output in a short lime. The speed of 2D barcode printers will not be able to keep up with the speed of manufacturing machines resulting in slowing down of manufacturing process. This results in long production time and increased cost.
Besides, many Indian companies are manufacturing products of foreign companies on contract manufacturing (neutral labeling) and such requirements of bar code are not stipulated by these companies. Exemption should be given for such products as they are manufactured under the label of a foreign company.
Explaining that the cost burden due to the implementation of bar coding on secondary level packaging will be huge and unbearable to the industry, especially to the small and medium companies, Munjal asked the government to seriously consider fiscal support and incentive to cover the incremental cost of implementing the trace and track system such as the cost impact of 10p per pack and the productivity loss of 20 per cent. Besides, there is an additional investment of Rs.46 lakhs per packaging line; cost of registration with GSl Rs.20,000 per month apart from monthly cost of Rs.1,00,000 for bar coding accessories like inks etc. for an average SME.
From the cost point of view, the small and medium drug companies will find it extremely difficult to implement the track & trace system, the IDMA president said.