While Maharashtra is gearing up to send show-cause notices for not cancelling the licenses of 225 pharmaceutical units that are found to have not even started the process of implementing Schedule M norms, the drug controllers of southern states have started the process of assessing the situation, respective Drug Controllers told Pharmabiz.
“The Maharashtra FDA has decided to issue show-cause notices to about 225 units in the state that are assessed to have not complied with the schedule M norms. If these companies are unable to upgrade their plants and technology according to the schedule M requirement, they will have to face cancellation of manufacturing licenses soon,” said Maharashtra FDA commissioner Ramesh Kumar.
Speaking to Pharmabiz, the commissioner said there are about 553 pharma units that have not reported to comply with the schedule M requirements, as per the latest available FDA data. Among these, about 330 units are in the process of upgradation as per the requirements. About 225 companies are yet to even start work on upgrading their plants as per the schedule M norms. These units will have to stop production, he added.
“The FDA would cancel the licence of these companies. When they upgrade their plants in accordance to the schedule M requirements, they can apply for a fresh license. The license would be issued to these companies once we are satisfied that they have complied with the norms,” said Ramesh Kumar.
R Ranga Rao, director, Andhra Pradesh Drugs Control Administration (APDCA) said the DCA would ensure that all the manufacturers including the small-scale companies comply with GMP standards. APDCA is organizing an interaction meet with small-scale companies in the state on July 6, 2005, and would then decide the future course of action.
Industry sources said the state has around 160 small-scale pharmaceutical units, and out of this, only 25 per cent have complied with the schedule M requirements. MRP based excise coupled with schedule M mandate has caused an unviable business situation in the state, causing closure of numerous units in near future.
Karnataka drugs control department sources said the department would adopt a wait and watch policy, as the government is yet to notify the amendments to Schedule M. “If the pharma units have failed to comply with Schedule M, then action has to be taken. But without a final notification of Schedule M amendments, it would be difficult to take stringent action against the defaulters,” stated Ramakrishna Gandhi, Karnataka drugs controller who superannuated from service on June 30 evening.
The new drugs controller MN Ramamurthy said the drugs inspectors would start inspecting the facilities within a few days to assess the level of non-compliance in the state. According to industry sources, more than 90 per cent of the units conform to the schedule M requirements, and only 5 per cent of the units are yet to upgrade their facilities.
Kerala would start inspection of facilities by the second week of July and finish the process within two weeks, said A Abdul Shukkoor, State Drug’s Controller.
The department has entrusted the job to four teams of trained inspectors posted at four zones in the state. Properly functioning pharmaceutical units in the state are less than 50. Hence, the inspection could be completed within a month. Then the non-compliant units would be served with show-cause notice for not cancelling their manufacturing licenses.
The Kerala DC noted the units would get another one or two month’s time to meet the requirements as their manufacturing licenses would be cancelled only after the show-cause notice period and a second inspection. Industry sources said about 75 per cent of the pharma units in the state have complied with the norms.
G Vijayakumar, the drugs controller of Tamil Nadu till 30th June, had told Pharmabiz recently that the department would start inspection of the facilities from the first day of July, if time extension was not offered for Schedule M compliance. Tamil Nadu is yet to appoint a new DC, and charge is conferred with a department of health & family welfare senior official.