Aurangabad bench of Bombay HC stays implementation of Schedule M
P.B.Jayakumar, Mumbai

The Aurangabad bench of the Bombay High Court has directed the Maharashtra Government to suspend the proceedings under Schedule M until the court takes up the matter for its consideration and comes up with further orders.

The Aurangabad bench admitted a writ filed by the Marathwada Pharmaceutical Manufacturers Association (MPMA) and the Small Scale Industries Pharma Association, Aurangabad, and restrained the respondents in the case, Ministry of Health and Family Welfare, Government of India and the Food and Drug Administration, Maharashtra from initiating action against the members of the petitioners until the court studies the matter.

The court, which admitted the petition on December 22, 2005 and posted the case on January 9, has extended the stay on proceedings against them till February, 23 2006, when the case comes up for hearing again. The court also has directed the petitioners "undertake to place on record material on the next date to substantiate the statement that substantial compliance of the requirement of Schedule M has been made by the members" of the petitioners.

Taking to Pharmabiz, Vinay Barath, president, Small Scale Industries Pharma Association said "The petitioners contended that revised Schedule M is applicable only for units that have been set up after 2001 and there is no justice in demanding all the units to comply with the revised GMP norms. The small-scale units have already invested Rs 50 to Rs 60 lakh for setting up the units and the new norms demand to further invest almost the same amount on modernisation, which is unaffordable for small-scale units."

Another point of contention was that the notification on 5th amendment to Drugs and Cosmetic Rules 2005 announcing amendments in the revised Schedule M norms was notified only on June 30 2005, and the rule came into effect since July 1 2005. It is impossible to carry out the changes overnight, and there is lack of clarity in elaborating the rules, the petitioners said.

An appropriate writ direction or order under Article 226 of Indian Constitution should be given by the court directing the Government to "postpone the effect and implementation of the notification dated June 30 2005 to some future date at least for a period of one year or reasonable time," the petitioners had demanded.

Courtesy : www.pharmabiz.com
1st February, 2006

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