The Federation of Pharma Entrepreneurs (FOPE) has urged the central government to give an extension of two years before implementing the new Schedule L-I of Rules 74, 78 and 150 E. It stressed that since the small and medium enterprises (SMEs) are yet to come to terms with the concept, they should be given some time to accept the impending changes.
As per the union health ministry's notification, all the pharma companies in the country have to adhere to the new GLP regulations under Schedule L-I of Rules 74, 78 and 150 E under Drugs and Cosmetics Act by November 1, 2010. Under the new regulations, pharma companies will need to have the necessary requirement of premises and equipment along with upgradation of their systems.
FOPE pointed out that it is strongly felt in the SME segment that there is a lot of gap between current practice and newer GLP norms. Apart from that there is also shortage of trained QC and QA personal to handle the change.
This issue was discussed by FOPE at a one-day pharmaceutical convention organised by FOPE along with Himachal Drug Manufacturers Association (HDMA) recently at Solan district, Himachal Pradesh. The conference aimed to deliberate on various issues in the common interest of all manufacturers and was attended by almost 250 people from the industry.
It was decided that a committee shall be set up under Vinod Kalani, general secretary, FOPE; Jetendra Kumar, vice president, operation QA, Mankind Pharma; Arun Kumar, Medicamen Biotech and Rajeev Saxena who shall study the GLP document. Once they study it, they plan to discuss the fine points with other professional bodies like IDMA, IPA to identify the operational problems with the new GLP.
The occasion was also utilised to discuss other major issues of the pharma industry. FOPE raised the issue of exemption to SSI which was denied because many units could not file declaration of SSI status within 60 days of start of the production. S M Jharwal, chairman NPPA, assured that they would consider the matter. It was told that the price difference demands against the SME’s are negligible if compared to total demand pending against the industry.
The Health Minister of Himachal Pradesh Rajiv Bindal in his speech appreciated the efforts taken by technocrats to establish state of art facilities in the state of Himachal Pradesh and assured all help and support to units manufacturing good quality products.
B R Sikri, co-chairman, FOPE narrated the initiatives taken by FOPE for resolving various issues of industries based at Himachal Pradesh and Uttrakhand excise free zones specifically.