Even as the pharmaceutical industry is locked in a fight with the authorities over the issue of fixed dose combinations, now the industry leaders are planning to focus on another issue formation of Central Drug Authority of India-, in an effort to make the proposed apex body more industry friendly.
Some leaders from the industry, mostly at individual levels, are trying to meet the higher officials and the Union Health Minister to highlight the possible harassments and difficulties they would face once the CDA is formed.
According to the industry sources, streamlining of the licensing and monitoring system was not objected to per se. But the provisions of getting licences from the Centre would be difficult for the manufacturers in all the States.
``There are also some hard provisions to make the present system more complicated. High penalties and longer procedures will make the working in the sector more tough,'' said a senior leader in the industry.
The small scale units claim that they would be hit more with the formation of CDA. They say that they were already finding the going tough with lots of pressures like WHO-GMP and excise duties. The new set up is going to put them more in trouble with regard to the licencing and running of units.
``It is no strange coincidence that while SSI number is declining, fake and spurious drug units are increasing. Framing strict new laws without taking social aspects into consideration can be disastrous. Input from SSI may be taken into account before CDA formation is finalized,'' sources said.
An industry leader informed that they would also be writing and seeking to present their contentions before the Parliamentary Standing Committee which is now examining the CDA Bill, presented already in the Rajya Sabh.
Besides, the industry representatives are also seeking time with the Health Minister to discuss the issue. Some members in the Parliament were also being roped in to take the industry views to the House when it comes for discussion, likely in the next Session.
The Drugs and Cosmetics (amendment) Bill 2007, seeking to set up the CDA was introduced in August. The bill provides for the authority controlled by a chairman and five members with comprehensive powers at the national level to control and regulate the pharmaceutical sector.
The bill also lays down detailed norms for licensing to the pharma manufacturers and penalties for defaults. It also has separate chapter on clinical trials.