Thousands of bulk drug manufacturers in the country have demanded to the government to provide level-playing field to the beleaguered bulk drug industry in the country to meet the increasing challenges being faced by the industry in the domestic as well as in the international markets. Some of the demands of the bulk drug industry included reduction in power tariff, bank interest rates, transportation charges, etc.
To discuss these issues and other burning issues, the department of pharmaceuticals (DoP) has convened a meeting with the Bulk Drug Manufacturers Association (BDMA) on February 7, 2014 in Hyderabad.
According to BDMA sources, power tariff, bank interest rates, transportation and other charges in the country are very high compared to other countries like China. To have level playing field, the government should lower the rates, including the bank interest rates for exports which is currently prevailing at 14 to 16 per cent per annum against international rates of around four per cent.
Likewise, registration charges in China for drug exports to that country are exorbitantly high when compared to the charges levied by India on Chinese products. As such Chinese products are highly competitive and to have a level playing filled, the registration charges by the Indian government should be made equal as those levied in China.
Another issue facing the bulk drug industry is that it has to approach different authorities for application for renewals. The licenses are given by the concerned departments for a period of one or two or three years and the industry has to again apply for renewals periodically. To save time and also to avoid frequent visits to the departments for renewals, the industry is demanding that the consents of different departments should be given for a period of five years so that work load to the department as well as to the industry is reduced.
The bulk drug manufacturers also wanted reimbursement of US FDA annual site registration fees under (MAI) Scheme as per Pharmexcil export promotion scheme.
On the pestering issue of environmental pollution, the bulk drug industry says that by very nature, the production of bulk drugs is associated with environmental issues. However these issues are possible to handle effectively with proper and co-ordinated approach from regulator and industry. The industry demanded that the government should promote dedicated industrial parks for production of bulk drugs with suitable buffer zones and shall not allow any residential areas in close proximity. These parks should have suitable provisions for environmental management and fire safety. As regards pollution, the regional pollution boards should be instructed to focus more on discharges and emissions rather than quantum of production.
Asking the government to take serious steps to eliminate the gap of the cost between India and other countries, the bulk drug industry asked for priority allocation for coal and bio fuel natural gas, cheaper land to develop mega pharma and R&D sector, soft loan, rational use of provisions of anti-dumping duty Acts & Rules, constitution of a committee of various government departments to help the bulk drugs industries through single window and audit of plants particularly in China.