|
The pharmaceutical Micro, Small, and Medium Enterprises (MSMEs) in Karnataka have sought an extension to comply with the Revised Schedule M of the Drugs and Cosmetics Act. The deadline for implementation is January 2025, but financial constraints see many MSMEs struggling to secure the necessary funds. Upgrading these facilities to meet the new standards often requires significant investment. Even as apprehension of closure of units looms large, efforts are on towards scouting for finance.
Both facility upgrade, installation of advanced systems and hiring the required workforce for quality management systems are crucial. These incur capital resources. It is here the Pharmaceuticals Technology Upgradation Assistance Scheme (PTUAS) is on top of the mind but MSMEs are in a ‘wait and watch’ situation, said Manoj Palrecha, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and managing director, Lake Chemicals.
No doubt, upgrading manufacturing facilities, training staff, and implementing new processes is time-consuming. Given the scale of the changes, MSMEs need more time to make these adjustments. There are complex technical and logistical changes that require expert assistance, requiring more time for compliance, he added.
This is an exercise most of the companies will not be able to do within six months of time. It needs a longer time to complete it in a phased manner. Efforts to seek an extension might involve engaging with government, presenting the reasons for additional time and demonstrating MSME efforts to compliance, he said.
An extension would allow these businesses to make the necessary adjustments without facing penalties or disruptions in their operations. Such support is crucial for ensuring that these smaller enterprises can continue to contribute to the pharmaceutical sector while meeting regulatory standards, he noted.
For the companies which are above Rs. 250 crore, revised Schedule M has come into effect. The reality is that 90% of the total 10,000 pharma units in India are MSMEs and will not be able to meet the stipulated deadline of January 2025. Being a price-sensitive market, MSMEs will not be in any position to recover their return on investment (ROI). These companies will encounter a huge financial crisis and a closure is imminent as six months is too short a time to comply. The government will need to take cognizance of this, Palrecha told Pharmabiz.
So far there is no communication from the government. MSMEs catering to only domestic market view it as problematic to meet the January 2025 deadline. Exporting units need to get a COPP (Certificate of Pharmaceutical Product) approval and so an extension till 31st December, 2025 is viable, he said.
Another issue is that along with facility upgrade, quality systems are crucial. Here Schedule M mandates a highly skilled and trained workforce for quality control and quality assurance departments which is a time consuming process and will take at least six months to appoint, train and meet these requirements. Considering these, it is important for the government to give an extension for effective implementation of revised Schedule M. Lest it could lead to a closure of many of the MSMEs. KDPMA has communicated the same to the government. It also conducted dedicated workshops for MSMEs on implementation of revised Schedule M, said Palrecha.
|