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Drugmakers are also upset by the wording of the undertaking they are required to sign to extend the 12-month extension on Schedule M applications.
Last week, a notification issued by the Ministry of Health announced the extension of the deadline for MSME drug manufacturers to meet the criteria specified in the revised Schedule M from December 31, 2024 to December 31, 2025. (Shutterstock)
Small and medium-sized drug makers have again urged the health ministry for a “condition-free” timeframe of two to three years to implement Schedule M.
Not just expansion, these drug makers have also asked the government to help them in the form of financial and technical assistance to improve quality standards.
They are also angry at the wording of the memorandum they have been ordered to sign by the Ministry of Health to seek a 12-month extension on Schedule M applications.
The notification issued by the Union Ministry of Health and Family Welfare last week was announced.
An extension for micro, small and medium scale (MSME) drug manufacturers to meet the norms specified in the revised Schedule M from December 31, 2024 to December 31, 2025.
While the extension was given to save thousands of small drug manufacturing units from failing future audits and eventually shutting down their businesses – as they brought their manufacturing sites up to global standards within a short period of one year. cited financial constraints in upgrading the An extension needs to be applied for through a separate form ordering an undertaking to be signed.
The language of the undertaking has sparked concern among some manufacturers, prompting the Small and Medium Pharma Manufacturers Association to send a letter to the Ministry of Health and Family Welfare, accessed by News18.
Pharmacists seeking upgradation must sign an undertaking that states: “I undertake that I have conducted a gap analysis and initiated the upgrade within three months from the date of this application and submitted a plan.” I propose to comply with the requirements of Revised Schedule-M as per …”
However, the pharma manufacturers, in their letter dated January 10, objected to the term “gap analysis” and the requirement to report to the Central Licensing Authority.
Nippon Jain, Chairman, Small and Medium Pharma Manufacturers Association, while discussing the letter on a call with News18 said, “Small and medium companies do not have enough funds to upgrade their facilities. Instead of firing us in the name of compliance with standards, the government should hold hands and help us, teach us to upgrade standards.
“The MSME industry needs facilitators and not inspectors,” he added.
What does the letter say?
According to the letter, the drugmakers believe the term “gap analysis” is vague and the requirement to report to a central licensing authority conflicts with the federal licensing structure.
While claiming to be committed to quality, these manufacturers warn against a hasty implementation of Schedule M that could cause many firms to close, leading to unemployment and rising prices.
“We would like to express our objections to your notification… regarding the implementation timeline of revised Schedule M for MSME manufacturers,” said Jain, who wrote the letter.
“Mentioning Gap Analysis in your notification is not in accordance with the “Drugs and Cosmetics Act”. The association has asked the government to “drop” the term.
Secondly, the letter states that applying to the Central Licensing Authority itself is “against the law.” “We are in a federal structure and our manufacturing license is issued by the state licensing authority. Reporting to the central licensing authority.”
“According to our honorable Prime Minister, there should be ease of doing business,” the association said.
“We are not against quality”
In the letter, the manufacturers said that MSME pharma manufacturers are not against the standard.
“We want to upgrade ourselves to global standards. However, hasty implementation of revised Schedule M will force closure of many MSME units leading to unemployment and price hike.”
The MSME pharma manufacturers highlighted that they had “repeatedly” requested the Drug Controller General of India (DCGI) on several occasions that they needed financial assistance and technical assistance.
“The current financial assistance offered by SIDBI to the pharmaceutical department is very burdensome. We need subsidy on interest on collateral free loans,” Jain wrote in the letter. “We need trained manpower from government teaching institutions as well as guidance from drug regulators.”
Further, he said that while these manufacturers are “with the government to improve quality standards”, “we need a condition-free time frame of two to three years with financial and technical support from the government”. “We hope you will take our suggestions in right spirit to help our MSME manufacturers,” he concluded.
