The Federation of Small Scale Pharma Industries of India (FSSPII) has sought the intervention of Union health minister Dr Anbumani Ramadoss to direct the State drug controllers to revoke the license suspension or cancellation orders issued to Schedule M non-compliant units.

In a memorandum to the minister, the association noted that such a relief would offer a fresh lease of life for the entrepreneurs and employees of the affected units, now finding it difficult to comply with the norms in a hostile business environment.

The association noted that majority of the SSI pharma units were established by technocrats under the old Schedule M norms as prescribed under the Drugs & Cosmetics Act, 1940. These factories were carrying out manufacturing work on behalf of various multinationals and other large corporates where excise and sales tax was paid on the contracted price. All these units have been efficiently running and the products have been well accepted in the domestic and international markets. Moreover, these units served the purpose of providing medicines at affordable prices to the poor and to Government hospitals. Many of the importers from the other countries are accepting the pharmaceutical products from the non-compliant Schedule M SSI units.

Pointing out that the excise free zones in North India have caused heavy exodus of units from various states, the association said the imposition of excise duty on MRP has put the death nail on the coffin of SSI pharma industry. Most of the multinational companies and domestic majors, who were clients of SSIs so far, have set up own manufacturing facilities in the excise free zones. Most of the SSI units have been established with norms of the old Schedule M as per the government policy to abolish loan license system just two decades ago. The new norms not only entail high capital cost but may also not be practical within the existing infrastructure or premises.

As there is nowhere in the world and also WHO guidelines do not specifies for the area of the production departments. The FSI in Maharashtra is 0.5 with the result that the units are not able to construct further area conjunct with L.T. line of 65 H.P which costs electricity charges of 4.50 per unit. Since that is the case, the Government should consider certain relief by way of time factor for simplification and relaxation of norms stipulated in the Revised Schedule M in case of oral preparation tablet, capsules, liquid, external preparation and bulk drugs, demanded the association.