Global Manufacturing Norms To Hit Drug Firms

Forget product patents, the new international guidelines on good manufacturing practices (GMP), currently under preparation, are likely to hit at the base of the Rs 2,000 crore Indian pharmaceuticals industry.

Indian pharma exporters, mostly bulk and intermediate drug manufacturers, are concerned over the coming guidelines which will harmonise US, European Union, Australian and World Health Organisation (WHO) guidelines into universal regulations governing the sourcing, manufacture, storage and distribution of pharmaceutical products, both bulks and formulations.

A "global standard for GMP" meeting was held in Washington in March which discussed starting materials for pharmaceuticals _ active ingredients, biologicals and radio pharmaceuticals _ as the basic building blocks of all medicines.

 

The meeting ended inconclusively with representatives from the US, EU and Japan deciding that further fine-tuning of their list was necessary before making it universally acceptable.

If this is converted into an international standard, then bulk drugs or formulations must be made only with those starting materials mentioned in the list. Manufacturers from China and India who are rapidly grabbling the bulk drugs market from European manufacturers will have to reorient their manufacturing practices to match the international standards.