The Union government needs to address the issue of ‘Export Obligations’ and take a re-look on ‘Norm Fixation’ and rationalize the registration process and fee, according to Anjan K Roy, president, Karnataka Drugs & Pharmaceutical Manufacturers Association and managing director, RL Fine Chem .

The API manufacturers should be given adequate support by the government for manufacture of basic intermediates. At present China is dominating the intermediate space. Government should address the ‘Export Obligations’ and take a re-look on ‘Norm Fixation’ and rationalize the registration process and fee. 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,” Roy told Pharmabiz.

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 added.

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. “This sector is registering a growth of around 18-19 per cent annually. The main revenues are coming in from the exports and we would be able to overtake Italy going by the number of drug master files (DMFs) being submitted. We have a clear edge over China in terms of quality and dependable supplies,” said Roy.