The Confederation of Indian Pharmaceutical Industry has pleaded with the Parliamentary Committee on Subordinate Legislation to consider dilution of a few clauses in the revised Schedule M and recommend adequate financial support from the central government to provide a relief to the majority of SSI units in the country.

In a letter to Dr Najma A Heptualla, Chairperson of the subordinate legislation committee which studies the implementation and impacts of revised Schedule M in the pharma industry, the CIPI appealed to consider inclusion of soft loans from Small Industries Development Bank of India (SIDBI) as part of revised Schedule M recommendations. Currently, the Bank considers each loan application individually instead of bringing them under a single scheme considering its common nature.

The Reserve Bank of India should issue a circular to all financial institutions that SIDBI is a nodal activity for financing units implementing revised Schedule M. The finance should be made available with moratorium period of two years and repayment period of 10 years at 8 per cent per annum and no institute shall insist on additional co-lateral security. Further, the letter that put forward a five-point plea added that the loan should be made available even for small amount, in multiplication forms of Rs Five lakh and the loan should not have burden on the pending loans.

The CIPI opines in its five-point appeal that the tax benefit in excise free zones should be allotted only for manufacturing and marketing of products and not for contract manufacturing products. The companies should be permitted to manufacture Betalactum in a separate room with separate set of equipments and it should not be made mandatory to have a separate building. Ancillary areas should not to be made mandatory even for new units.

Besides, the letter seeks consideration of the committee on the mandatory installation of Air Handling Units (AHU), which according to the Confederation is only necessary for injectable manufacturing area. It explains that that the other manufacturing sectors including warehouse need only filtered air or air conditioners to avoid external contemplation, while the current form of Schedule M insists installation of AHU in all the manufacturing plans without considering the nature of plant.

"With the dilution of the revised Schedule M an extension of 18 months should also be permitted from the date of notification of the dilution in Schedule M. This will help a majority of small scale companies which are have stopped the up gradation programme in half way lacking investment capacity for facilities including AHUs," T S Jaishankar, chairman, CIPI told Pharmabiz.

"This is our humble request to the parliamentary committee on the difficulties encountered by the SSI pharma units with respect to implementation of revised GMP norms. We shall be grateful if at least these minimal points be considered immediately so as to enable SSI Pharma sectors to offer 20 lakh samples and an investment of over 5,000 crore all over India," he added.

The CIPI has submitted its appeal to the Parliamentary committee in a meeting held at Chennai. The Parliamentary committee on subordinate legislation to study the implementation and impacts of revised Schedule M in the pharma industry held its second meeting at Chennai in the second week of February.