Indenting agents in the pharma industry play an important role as they mediate between manufacturers in India and importers from countries like China. This relationship has grown to be mutually beneficial for all concerned parties. Chinese pharma?s capabilities in making low-cost active pharma ingredients and intermediates is a proven fact and indenting agents help source low-cost ingredients for bulk drugs and formulation manufacturers. Indeed, the profit margins of Indian manufacturers hinge on the availability of low-cost pharma raw materials from China and a drop in supply has a severe impact on production schedules in India. This was most apparent when Chinese manufacturers violating environment pollution rules were forced to stop production in the run up to the Beijing Olympics.
As go-betweens, indenting agents have been taking the responsibility of ensuring that the imported consignments comply with the rules laid down by authorities in India. They follow up with representatives of the regional drug controllers? offices, navigate the maze of custom regulations at various ports of entry and take on the responsibility of paying fees to register the Chinese manufacturers they represent.
But the agents have concerns about escalating red tape at entry points, especially as the scare of spurious drugs has forced authorities to mandate more frequent checks. Plus, global authorities today want to know the antecedents of not just the end product but also each ingredient and starting product. Imported formulations need registration certificates of multiple manufacturing sites. Regulators justify these measures saying that indenting agents will have to do due diligence to vet the manufacturers they source from, because they are the face of the manufacturer in India.
The Indian Drug Manufacturers? Association has already made representations to the authorities highlighting some of these issues. The indenting agents have recently come together to form the All India Pharma Indenting Agents Association in order to represent their grievances in a more structured manner. As always, the regulator will need to be pragmatic and find a solution that is both speedy and acceptable to most stakeholders, without compromising on quality. Finding the greatest possible good for the greatest possible number of individuals will take time. As one regulator put it, commerce is important but so is compliance.
viveka.r@expressindia.com