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CIPI chairman says the pharma MSME sector had expected unconditional extension and financial aid from the government

Our Bureau, Chennai
Monday, January 6, 2025, 12:15 Hrs  [IST]

Responding to the draft notification issued by the union health ministry last Saturday, the chairman of the Confederation of Indian Pharmaceutical Industries (CIPI), R K Jain, has commented that the MSME sector had expected a blanket extension of the revised Schedule M without any condition.
 
Also, all the micro, small and medium pharmaceutical enterprises expected financial aid from the government in support of the new Good Manufacturing Practices, he added.
 
CIPI, the alliance of pharma industries organisations representing the MSME sector in India, had earlier submitted a memorandum to the government urging for an extension of the deadline set by the ministry. R K Jain was speaking to Pharmabiz in the wake of the new notification issued by the Union health ministry on January 4, Saturday.
 
“It was a demand for an extension of the deadline as it is, not with any condition. Now they have extended it on condition that those who submit applications affirming compliance with higher standards of good manufacturing standards within a specified time not beyond December this year,” he said.
 
There is no choice for the MSME industries now, only to keep pace with newer quality standards being practiced the world over, Jain said by adding that the government of India has actually shown a big heart to accommodate the MSME industries. The only shortcoming the confederation finds is that the government should have avoided the requirement of submission of any application in the prescribed proforma annexed with the notification.
 
Jain said the step taken by the ministry conveys one fact that those industries who do not want to upgrade their facilities by investing huge amounts of money in the next one year can leave the field whenever they want as they will not get extension. But those who want to continue their operations need to comply with the higher standards through upgradation. They will have to submit the application in the next three months.  Otherwise, they will invite the wrath of the regulatory authorities during this period of one year.
 
When asked whether the government is now putting the MSME sector into trouble through this amended notification, the CIPI chairman said he does not find any trouble in the decision of the government, but said the units who volunteer to upgrade will be subjected to frequent audits by the regulatory authorities.
 
To another question whether the present notification will help the industry to go hand-in-hand with the regulations, he said there may be differences of opinion amongst the regulatory bodies and the industry. It may be transparent for the regulator to check whether the unit has complied with the commitment it had given. As of now the regulator audits the units as a whole and not by the standards which may have been committed by the respective unit.
 
According to the MSME leader, the pharma industry has to accept whatever the guidelines set by the government periodically provided the industry wants to continue in the field.

 

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