Indian pharma majors with high export profiles are increasingly turning to highly sophisticated cleanroom products to remain in the highly competitive global pharmaceutical market. Drug regulators in the US and European Union are tightening the regulatory and monitoring systems to filter out low quality products from their markets,

The importance for dedicated products including cleanroom control products and other materials used inside the cleanroom facilities to avoid contamination is increased in the past couple of years. This has opened up a huge market for the cleanroom control products and even cleanroom gloves, footwear and head-cap with US FDA or European regulators' approval, says Madhav Parekh, managing director, Kitten Enterprises Pvt Ltd, a company which markets imported sterilisation and hygiene products in the country.

"The current cleanroom practices in many of the firms are not in compliance with right standards. But, with the regulators of the western markets getting stricter, the Indian exporters cannot afford to take risk on cleanroom products. More companies are looking for the cleanroom products which adheres to the standards of the destination country," he said.

Kitten Enterprises, for instance, which has almost 500 products dedicated to the pharma sector out of a total of 700 products marketed in the country, has tied up with European and US firms to import and market more than 300 cleanroom solutions and related materials.

Of late, the company has launched three more products with primary usage for pharma cleanroom facilities - a hygene control product for cleaning equipments and surfaces, a washroom control product with European quality standards and an advanced microbial sampler to clean air in the controlled area. Earlier, it had launched paper, pen, footwear and other tools to be used only in cleanrooms, to avoid contamination.

It has also plans to launch specially designed telephone, vaccum cleaner and chair dedicated to use inside cleanrooms in pharmaceutical facilities, imported from the western market. "Market for these types of products are very huge in the western market. In India, it is just a novel area. Many a times, the price for these products are much higher than the ordinary products available in our market and this made the companies to stick on to such products. Now the situation is changing and many who laughed at the idea at first are now realising the importance of these products," maintained Parekh. However, the market for such products is still in a nascent stage in India and cannot be quantified at present, he added.

Even a negligible mistake in cleanroom practices may lead to rejection of the product from the western market and to avoid that, the companies have to be vigilant in every minute details of the cleanroom arrangements, agreed an expert from the industry. Compared to the higher loss of consignment rejection, increased cost of such specially designed dedicated products would be reasonable for the firms, at least for the pharma majors in the country, he added.