The small-scale pharmaceutical manufacturers have requested the high power committee on subordinate legislation (Rajya Sabha) to recommend the government to set up a Review Committee on revised schedule M and to suspend the current plan to implement the norms before June end 2005, until the committee submits its final recommendations.

A delegation of the Confederation of Indian Pharmaceutical Industries (CIPI), which met the high power committee last week for hearing, pointed out that the deadline was hardly 45 days away, and numerous units would close down after the deadline as about 4000 units are yet to complete the modernization process. Closure of these units would lead to unemployment of about nine lakh workers.

The committee has to hear the version of other stakeholders and authorities, and its final recommendation would take sometime. Considering the gravity of the situation, the committee should immediately recommend the government to appoint a Review committee and to suspend the Revised Schedule M norms with its present deadline, appealed CIPI.

Industry leaders feel the meeting was helpful to convey the crux of the issue and problems of the SSI's to the MPs and decision makers, as the problems of SSIs were not properly represented in most of the earlier crucial industry-decision makers meetings to discuss policy changes. CIPI informed the committee that it was not against modernization, as portrayed and felt by a section of the industry and officials. The SSIs have been demanding dilutions to the Revised Schedule M norms for sometime. About 540 changes were incorporated in the guidelines, of which about 40 per cent of the clauses are difficult to implement. Ambiguity in clauses like 'wherever applicable' could lead to harassment by the regulatory officials.

Independent industry observers assess the strategy of the SSIs would be to exert political pressure on the government with the help of influential left parties, to either get further extension or suspend the current revised schedule M norms, if the high power committee recommends reviewing the norms. Already the SSIs have support of some of the influential left party leaders. The SSIs are cleverly not demanding further extension as the government has already given two extensions to the deadline, they note.

The political game has begun with Basudeb Acharya, a CPI (M) leader in Lok Sabha and Rupchand Pal, CPI (M)'s chief whip in Lok Sabha writing a letter to the union health minister demanding to wait for recommendations of the high power committee. The MPs felt the Revised Schedule M was beneficial only to the multinationals and causes havoc with 5000 small-scale manufacturers with a total turnover of Rs 7000 crore and their workforce of nine lakh workers. The SSIs make available drugs at affordable prices to the common man, and the price difference between MNC products and SSIs is in the ratio of 4:1. The amendment forces SSIs to adopt European standards of hygiene, and these unrealistic parameters are unrelated to Indian realities, said the MPs.