TAKE MSMEs INTO CONFIDENCE-- In a welcome move for thousands of small and medium pharmaceutical units spread across the country, the Union Health Ministry, on January 4 this year, had come out with a draft amendment extending the deadline for implementation of Revised Schedule M till December 31, 2025. To bring the quality of Indian pharmaceutical products on par with the international quality standards, the Ministry had earlier notified the Revised Schedule M on December 28, 2023. The notification mandates that the drug manufacturers with annual turnover of more than Rs. 250 crores have to comply with the Revised Schedule M within six months and for MSMEs with less than Rs. 250 crore annual turnover, the timeline has been fixed at 12 months. For the companies which are above Rs. 250 crores, the Revised Schedule M has already come into effect and the regulatory authorities have started inspections. The deadline for MSMEs for upgrading their units as per the Revised Schedule M was January 2025. Now, the Ministry has extended the deadline by one year. The latest draft amendment provides for small and medium manufacturers with turnover of below Rs. 250 crores to seek extension of the timeline for implementation. These units shall make an application to the Central License Approving Authority in a form provided with the notification within a period of three months from the notification, along with the plan of upgradation. It has also provided Form A, the application for grant of extension of compliance with revised Good Manufacturing Standards, under Schedule M of the Drugs Rules, 1945. Quite expectedly, the small and medium pharmaceutical units are up in arms against the conditional extension of implementation of Revised Schedule M, that too just by one year. Ever since the notification a year ago, the industry associations representing MSMEs have been demanding to the Ministry to extend the timeline by at least two more years to implement the new quality standards. It is true that because of financial constraints, most of the MSMEs are struggling to upgrade their units as they have been running from pillar to post to secure the necessary funds. Upgrading these facilities to meet the new quality standards requires significant investment as facility upgrade, installation of advanced systems and hiring the required workforce for quality management systems are crucial. 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. No doubt, a quality boost was the need of the hour for the Indian pharmaceutical industry, especially in the backdrop of the fact that, for the last couple of years, the Indian pharmaceutical industry’s image has taken a severe beating following the WHO holding Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan. Of course, there can be no two opinions about the fact that implementation of Revised Schedule M was a right and timely move by the government to achieve global quality standards in the Indian pharmaceutical industry. All said and done, it is a fact that a large number of the total of around 10, 500 pharma units spread across the country is MSME units which are the backbone of the pharma sector in India. It is also a fact that these units have been given more than six years to upgrade their units as the government had released the draft guidance more than six years back. However, the fact remains that MSMEs are crucial for a country like India where a large number of the total 140 crores of people need cheaper medicines which could be possible only through MSME units. The Ministry should take the micro, small and medium pharmaceutical manufacturers into confidence before coming out with the final set of rules. for more information, visit - acplgroupindia.co.in/newsletter call - 9266665201 email - info@acplgroupindia.co.in