State DCs to take action not implementing Sch M

Action will be initiated right now for those units who have not applied for the extension, as the revised Schedule M is already applicable for such units,” said Dr Rajeev Singh Raghuvanshi, DCGI.

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The decision is expected to impact the existence of thousands of small and medium units who have not applied for the extension, and have been waiting for the centre to provide further relaxation of timeframe. Some of the units have already decided not to go for the revised Schedule M compliance and either shut down the unit or sell it to parties who are interested in upgrading the facility.

FURTHER EXTENSION RULED OUT

“In case any manufacturing unit is found noncomplying to the requirements of revised Schedule M during inspections, strict action shall be initiated against such units as per the provisions of Drugs and Cosmetics Act and Rules thereunder,” added the central drug regulator.

The State and UT drug regulators have to submit a monthly report to the Centre with details of inspections and observations made, and the actions taken pursuant to such inspections.

“This may be treated as Top Priority and compliance is required to be ensured strictly,” added the DCGI.

According to reports, Himachal Drug Manufacturers Association president Dr Rajesh Gupta has recently said that though the micro, small and medium enterprises are trying to comply with the revised standards, considering the investments required, at least 4,000-5,000 units might be forced to shut down and this may trigger shortage of critical drugs in the domestic market. Suspension: permanently prevent caking / sedimentation

Toothpaste: prevents drying up / water separation while giving fine texture

Emulsion: prevents emulsion breaking while giving fine texture

Tablets: Improves dissolution, binding & flow properties Our Bureau, New Delhi