Pharma SMEs seek a year-long deadline extension to implement new labelling norms for drugs

As the deadline for implementation of labelling change for drugs is approaching fast, the small and medium pharma industries have called upon the Union Health Ministry to carry over its implementation by a year to salvage them from incurring a loss which could go over Rs 300 crore due to huge buildup of packing material stocks.

The ministry has already extended the implementation of a label change for a bigger font size of generic names from September 13, 2018, to April 1, 2019, through a gazette notification on December 3, 2018. In another draft notification on December 7, 2018, it extended implementation of new labelling norms for Schedule H, H1, G and X drugs from November 1, 2018 to April 1, 2019. However, the ministry is yet to come out with final notification in this regard.

According to small and medium pharma industries, the labelling changes will not have any impact on product efficacy, patients safety and product quality.

Amit Chawla, Director McW, says, “Though the above changes do not reflect on the medicines quality and prices, the pharma industry has already started taking measures to move over to the new packing. However looking at the huge buildup of packing material stocks, we request that the final implementation dates should be deferred by one year at least i.e. voluntary basis change over till March 31, 2020 and on mandatory basis from April 1, 2020.”

Amit Chawla is also the Vice-President of Laghu Udyog Bharati Indore unit and Secretary of Madhya Pradesh Small Scale Drug Manufacturers Association

"We generally keep one year stock of packing materials in advance, the materials get consumed during peak season ranging from April to September. Hence we are looking for year long extension of deadline for implementation of the said packaging changes to avoid losses, said a representative from drug industry", he added.

He further says that last month a Laghu Udyog Bharati delegation had called on Mandeep Bhandari Joint Secretary, Union health ministry urging him to defer the implementation of both labelling changes till April 1, 2020 as the changes in drug packs will not have any impact on efficacy and quality of drugs.

"We hope that our request for extension will get accepted by the ministry to streamline the implementation of the above notifications", he adds.

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