The Confederation of Indian Pharmaceuticals Industries (CIPI), the apex body of small-scale pharmaceutical units in the country, has suggested the Union Government to look into the existing Schedule M norms and to form a fresh committee with SSI industry participation to make the guidelines simplified and cost-effective to help the units comply with the mandate on modernization.

In a meeting with Dr. Anbumani Ramadoss, the union minister for Health and Family Welfare in Delhi, last week, a CIPI delegation represented that most of the SSI units were finding it difficult to modernise their plants as per the norms of Schedule M with a deadline of December 31, 2004.

Some members of CIPI who studied on the existing norms found out that about 535 points have been amended in the norms, when compared to the earlier guidelines. The existing guidelines were formulated during early 2000 considering the Indian industry scenario then, when the Indian economy was opening up to welcome overseas companies and to boost Indian exports. The committees, which recommended the changes, lacked proper representation for the small-scale sector and had not correctly analyzed the concerns and genuine problems of the SSI sector.

The norms, technical terms and official jargons in the guidelines have compounded the worries of many entrepreneurs causing them to believe complying with Schedule M will cause huge investments on the part of the SSIs. Instead of stringent norms on air handling which demands extensive arrangements to set up a clean environment within the premises, the norms could be simplified to mandate air-conditioning facility to reduce the investment burden. Similarly, the government could notify and publicise in its website the standard norms for maintaining the records of production to help the entrepreneurs what all are required in the documentation process. According to the guidelines for Schedule M, production records run into more than 50 pages instead of the normal practice of maintaining few pages, and many entrepreneurs are confused on the requirements, noted the delegation.

The SSI sector is not against improving their manufacturing premises, but some of the impractical suggestions compound the problems. Hence, it was imperative on the part of the government to form a fresh committee with CIPI participation. The government should, therefore, put on hold the existing deadline for conforming to Schedule M, demanded CIPI, T S Jaishankar, chairman of CIPI told Pharmabiz.

If the government was willing to look into the matter, CIPI was ready to come out with details on the 535 points and to discuss them, said Jaishankar.

The delegation also met union minister for Chemicals and Fertilizers and minister for state, Chemicals and Fertilizers, besides top officials and many Members of Parliament to sensitize them on the genuine problems of the SSI sector, said Jaishankar.