The Federation of Small Scale Pharmaceutical Industries of India (FSSPII) has urged the Group of Ministers (GoM) on Pharmaceutical Policy headed by Sharad Pawar to exempt small pharma companies, who have license before December 2001, from implementation of revised schedule M.

In a letter to GoM chairman and Union Agriculture Minister Sharad Pawar, the federation has requested that the pharmaceutical manufacturing units with license before December 2001 should be exempted from implementation of revised schedule M on the lines of safety belt, under the motor vehicles act, is not applicable to old vehicles.

The FSSPII, an organisation of small pharma units in Maharashtra, in its letter also asked the Minister to revoke the suspension and cancellation orders on manufacturing license of the SSI units by various state drug control administrations. It also regretted that though the government assured Rs 500 crore for up gradation of the facilities for small and medium scale pharma units, nothing has materialised so far.

It also added that the installation of air handling units (AHU) is a step only cosmetic in nature, without much effect on the quality of product in case of oral and external formulations and bulk drugs.

"In a similar tough situation a year ago, when the Maharashtra FDA commenced corrosive action against small scale units, the Minister instantly ordered the state secretary to stop further actions. We expect similar sympathetic approach from the Minister as the Chairman of Group of Ministers," Dr T S Malvankar, president, FSSPII told Pharmabiz.

The letter further mentioned that with the suggestions made by several MPs to keep revised Schedule M implementation in abeyance till Parliamentary committee led by Dr Najma Heptullah submits its final report, the Health department, instead of taking destructive measures, should have shown restraint. Instead, the Union Health Minister had replied that many SSI units have complied revised Schedule M norms, hence it will be an injustice on those companies to keep the rest of implementation in abeyance. "If this is the situation, we would like to ask why the thousands of non-compliant Schedule M units have been closed by various state FDA Departments and what is the purpose of appointing a Parliamentary review committee?" asks the letter.

The SSI units are planning to raise the issue again in the Parliament with the support of some MPs, and to keenly pursue the developments of the Parliamentary committee proceedings, said Malvankar.