Indian Active pharma industry manufacturers are insisting on the creation chemical special economic zones (SEZs) which will have effluent treatment plants. This will allow companies to focus on production without getting into hassles of state pollution control boards during production of these hazardous wastes.
According to Anjan K Roy, managing director, RL Fine Chem and president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), API units constantly are visited by pollution control officials and there is a major problem handling such situations. Since APIs production alls for considerable investment in time, money and expertise, we need to be left alone with the problems effluent emissions and discharges. This is where a dedicated chemical zone will provide the much- needed relief.
When planning a dedicated chemical zone with SEZ status, the government should also look at locations to ensure supply of uninterrupted power and water in addition to adequate infrastructure which includes roads, he added.
Earlier he had pointed out that the Union government should address the issue of ‘export obligations’ and take a re-look on ‘norm fixation’ and rationalize the registration process and fee.
The API manufacturers should be given adequate support by the government for manufacture of basic intermediates. At present China is dominating the intermediate space. In China, API manufacturers from India have to go in for product registration and seek plant audits directly from the regulatory body with no agent intervention. “But for Chinese manufacturers in India, the products are registered through agents and do not need plant audit. This has led to substandard products. Our government should realize the seriousness of this issue and take action immediately by putting in stringent regulations in place to ban such practices,” he added.
API manufacturers are facing competition from China mainly in antibiotics, hypertensives and anti malarial drugs which include cephalosporin, quinilones and sartans.
“We have put in several representations and API manufacturers want the Government to create chemical zones with effluent treatment facilities. If these basic infrastructure which includes road, power and water and environmental issues are taken care of by the government, then companies can focus on research and production. But the point to be made is despite several efforts requests are not addressed,” he said
Current scene indicates that Indian API industry has enormous opportunities as various products are going to be off patent. There is a huge scope for development of new chemical entities. The future growth of the API industry in Karnataka will depend on the plant expansion. “For this we are looking at a dedicated park or a special economic zone spanning over 250-350 acres in and around Bangalore. This could come up on similar lines like Vizag in Andhra Pradesh,” he added.
The API Industry in India meets around 70 per cent of the country's demand for bulk drugs, drug intermediates & chemicals. India is ranked third after China and Italy. Very soon, India will be able to over take Italy and take the second slot in the global market.