The small scale drug units have urged the parliamentary committee on subordinate legislation, entrusted to conduct study on the implementation of revised Schedule M, to recommend the central government to take steps for reducing hardships faced by the SSIs in complying with the revised norms.
The Federation of Small Scale Pharma Industries of India (FSSPII), an association of small scale pharma units in the country, requested the committee to recommend the central government not to implement the revised Schedule M on the units whose licenses are issued before December 2001 and to revoke the suspended and cancelled licences of SSI units by various state drugs control departments.
In a letter to Dr Najma Heptulla, chairperson, Parliamentary committee on subordinate legislation, the federation has also requested to exclude the Air Handling Unit (AHU) from the mandatory list, as it is only cosmetic in nature and would not make much effect on the quality of products in case of oral, external formulations and bulk drugs. The letter also seeks an appointment with the committee members to have detailed discussion on the issue before the submission of the final reports.
"We are planning to visit the committee members and the ministers and officers of the concerned ministries to put forward our pleas in detail. The government has not issued single paise for the SSIs from its proclaimed Rs 500 crore facility up gradation fund. It is an injustice to pressurise the SSIs to comply the norms in this situation," Dr T S Malvankar, president, FSSPII told Pharmabiz.
Meanwhile, A Vijayaraghavan, Member of Parliament and the former Chairman of the Parliamentary committee studying implementation of revised Schedule M, has also requested the Health ministry to exempt old units from the amended norms as a large number of persons are dependent on it. In a letter to Dr Anbumani Ramadoss, Minister for Health and Family Welfare, by the beginning of February 2007, he added that the small-scale units are unable to install the costly facilities like air handling units without financial help.
The federation has also requested the Member of Parliament to raise the issue in the current parliament session. "We think that the MP and many other likeminded leaders will help us to find a way out of this problem. We have also extended the request to Sharad Pawar, Minister of Agriculture and Consumer Affairs who is heading the group of ministers in reviewing the new drug policy for which he reverted with enough empathy," added Malvankar.
The parliamentary committee, which studies the implementation and impacts of revised Schedule M in the pharma industry, is to seek the feasibility of norms under the new format, and to asses the obstacles faced by the industry in complying the new norms. The SSIs in Maharashtra are desperate to get a favourable support from the parliament committee as the Food and Drugs Administration (FDA) has commenced to implement the revised Schedule M norms, added the federation sources.