Pharmaceutical investors hopeful of getting extension

With less than two months remaining to adhere to the revised Schedule M stipulation of the Good Manufacturing Practices norms, the pharmaceutical firms falling under the micro small and medium enterprises category are yet to get an extension in the deadline.

As per a notification issued in December 2023 by the Union Ministry, those failing to comply with the stipulations by December 28 will face suspension of their licence or a penalty. The revised norms will bring them on a par with the World Health Organisation’s norms.

Citing fund constrain as the upgrade requires a minimum investment of Rs 5 to Rs 6 crore, the Himachal Drug Manufacturers Association (HDMA) has been demanding three years for its implementation.

Comply by December 28: Ministry

• A notification issued by the Union Ministry says that those failing to comply with the stipulations by December 28 will face suspension of their license or a penalty. The revised norms will bring them on a par with the World Health Organisation’s norms
• It has been observed that some firms regularly figure in the monthly alerts issued by the Central Drugs Standard Control Organisation thus putting a question mark on quality drug manufacturing
• Citing a fund crunch, the Himachal Drug Manufacturers Association has been demanding a period of three years for its implementation

The need to upgrade the manufacturing facilities was being urgently felt by the Union Ministry to ensure compliance of the global quality standards and to avoid hassles of international drug recalls which has been besmirching the image of the Indian pharmaceutical firms globally.

In Himachal, too, it has been observed that some firms regularly figure in the monthly alerts issued by the Central Drugs Standard Control Organisation thus putting a question mark on quality drug manufacturing.

In the monthly drug alert issued for September, as many as 11 injections were declared not of standard quality among 25 drug samples manufactured in the drug firms of Himachal.

The revised Schedule M has been devised to overcome the lacunas in the manufacturing by adopting upgraded standards. As per the revised norms, the manufacturing area has to be divided into eight areas or rooms for injectibles where specific area for each section has also been prescribed.

It was observed that despite space constrain some firms were manufacturing several products like injections, tablets, liquids, etc., and this often led to quality issues.

A delegation of Himachal Drug Manufacturers Association (HDMA) who recently met union health and family welfare minister JP Nadda is, however, hopeful that the deadline will be extended beyond December 28.

Dr Rajesh Gupta, president HDMA, when quizzed, said that “The HDMA has given a representation to the union health minister JP Nadda and we are hopeful that we will get an extension in the deadline for implementing revised schedule M stipulations.”

He said the industry welcomes the move but is only seeking time as arranging crores for a MSME unit and undertaking upgrade in a running unit requires time.