Union government is working on to lay down a set of standards for medical face masks manufactured in the country and for imported ones soon. The need for a standard format comes is important with the onset of the second virulent wave of H1N1 flu. In the absence of a Medical Face Masks Association, Thea-Tex Healthcare (India) Pvt Ltd a leading manufacturer of high quality masks has provided its recommendations to model a standard on the European Surgical Mask format of EN14683.

"We have no idea how long the process will take or if they indeed will use our suggestions," Anand Singh, marketing director, Thea-Tex Healthcare (India) Pvt Ltd told Pharmabiz.

To begin with in 2006, in the wake of the Bird Flu scare, Thea-Tex Healthcare approached the Bureau of Indian Standards on the need for standardisation of the face protection gear. Singh in his capacity as a leading manufacturer of medical face masks had written to many government departments including the National Institute of Communicable Diseases, The Directorate General Health Services, Department of Animal Husbandry strongly advising the need for some type of preparedness plan and regulations for surgical masks.

"We did not receive single reply after which we stopped trying with the Government and concentrated on making our products comply with the European Mask Standard and the USFDA norms," he added.

There was no action plan when H1N1 struck and there was a scramble in the mask market with 'fake' masks and N95 respirators being imported from China in an unregulated manner. "Since the government of India has now evinced interest in developing a standard for medical face masks, we as a company have recommended for an immediate formulation of standard," he said.

Almost 99 per cent of the masks sold in India are 2-ply masks that would not qualify as surgical masks in Europe or the USA. The consequences is severe in terms of poor infection control. Also, the mask industry should be under the purview of a regulatory body such as the FDA like in the USA. India requires 3-ply masks with bacteria filtration efficiency. Only then the purpose of wearing a mask is achieved, said Singh.

The global mask market is dominated by China. Being a disposable product, the price factor comes in for the large foreign buyers. Indian manufacturers simply cannot compete with Chinese manufacturers going by the substantial export subsidies and capability to mass produce masks. If an Indian company like Thea Tex can produce 20 million pieces a month a small unit in China produces 2 million per day. The domestic mask market has around five established manufacturers with imported Taiwanese production lines.

In India the mask market is still developing and with 1.2 billion people there are plenty of growth prospects. The consumption is steadily increasing by about 25 per cent year-on-year. Going by the rise in air pollution levels, soon two -wheel riders and commuters will need to use masks instead of handkerchiefs which will automatically kick in a demand explosion.

Unfortunately the mask market is a bit messy at the moment with the hangover of H1N1, as there is a lot of imported stocks in the market. There is also overcapacity for the domestic mask companies. However, we feel within 12-24 months the market will again stabilise as demand increases, stated Singh.