Pharmabiz
 

cGMP compliance yet incomplete; SSI plea for another extension

P B Jayakumar, ChennaiMonday, September 20, 2004, 08:00 Hrs  [IST]

The small-scale sector drug manufacturers in the country still nurse hopes of getting another extension to the Schedule M compliance deadline, at least for one year up to January 2006. The SSIs are planning to soon create a momentum for the extension campaign. The Confederation of Indian Pharmaceutical Industries (CIPI), the apex organization of various state level pharmaceutical manufacturers associations, is planning a mega meeting of its representative associations in New Delhi on 16th of October to discuss the issue and to analyze the progress of Schedule M implementation in various states. The Association is also in the process of assuring various key influential political bigwigs and even the union minister for health and family welfare to attend the meeting. They hope the meeting could impress upon the leaders, minister and other authorities on the necessity for giving extension. It may be noted that the politically lobbying strategy had worked well for the SSIs in getting extension for one year during December 2003. Sources point out this was the only practical solution for buying further time as the drug control authorities are adamantly against providing further relief. Meanwhile, industry observers say the momentum of the modernization process has gone down in the last few months, though the deadline is just three and a half months away. According to T S Jaishankar, chairman of CIPI, this is mainly due to various factors like the fear of new patent regime, government's indifference to notify the proposed dilutions in Schedule M norms, inability to avail subsidy, and above all complacency and hopes of many manufacturers to get further extension. Many manufacturers are worried about what could happen in the post 2004 patent regime, and some of them have opted for a wait and watch policy instead of investing numerous lakhs for modernization. Similarly numerous SSI units are waiting for the promised Schedule M dilutions, as that could considerably reduce the investment burden. Several manufacturers across the country also complain that they were unable to avail the 20 per cent subsidy offered by SIDBI for modernization. The banks forward the proposals to SIDBI, which is the nodal agency, and after many months of procedural verifications, most of the banks are reluctant to offer the loans. Very few manufacturers in the country have been able to avail the subsidy so far, say SSI sources. The prime aim of the Delhi meeting would be to realistically assess the modernization process, so far. Though it is estimated that more than 1000 units have already modernized, exact statistics are not known. Of the remaining units, only about 20-25 per cent are in the various stages of modernization, or have just initiated the process. The CIPI leadership has directed each of the state associations to have a detailed presentation in the meeting on the status of modernization in their territory, informed Jaishankar.

 
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