New labeling norms to hit margins of small pharma units

Vijay C Roy

Tribune News Service

Chandigarh, March 20

Piled up with huge inventory of packing materials, the small and medium sized pharmaceutical companies of the region have requested the government to extend the deadline for the implementation of new labelling guidelines for scheduled drugs by at least 6 to 9 months. The new norms will come into effect from April 1.

According to industry, there are around 1,000 pharmaceutical units in the region in the SME category, each having build-up packing material stock anywhere between Rs 50 lakh and Rs 5 crore. 

Perturbed over approaching deadline, the small and medium pharma industries have sent their representation to the Health Ministry to extend the deadline to save them from losses which they expect to incur with new guidelines.

Earlier, the ministry had done away with the requirement of maintaining same font in generic name and brand name after consultation with the industry. Later on, it had come out with another notification, omitting the requirement of printing the brand name or the trade name in brackets below or after the proper name of drugs, after the industry expressed concern. 

As per the new norms, the drug manufacturers have to print box warning or caution in red colour on Schedule drugs.

“What will happen to the packing materials which have already been printed? We will take up this matter with the Drug Controller General of India in forum meetings. The changes in labelling norms will not affect the quality and prices of medicines. So, there will be huge loss of packaging material,” said Pharmaceuticals Export Promotion Council of India (Pharmexcil) chairman Dr Dinesh Dua.

“The region-based SMEs have a huge stock of packing materials. We are not against the government’s decision to implement the new guidelines but only want the deadline to be extended by 6 to 9 months so that the SMEs can consume the old packing stock,” said Himachal Drug Manufacturers Association president Dr Rajesh Gupta. 

Some of the small pharma units have already started taking measures to move over to the new packing.

“As smaller units are always struggling with working capital, they buy packing material in smaller quantity. The small pharma units have already exhausted the old stock of packing material such as mono foil and mono-carton, so the current dispatches are made in new packing as per the specifications prescribed by the ministry” said Karnal Pharmaceutical Manufacturer Association president RL Sharma.