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Telangana IDMA warns of closure of small & micro units if revised Schedule M deadline is not extended
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Peethaambaran Kunnathoor, Chennai
July 28 , 2025
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Telangana's small and micro-level pharmaceutical industries are staring at the closure of their units once the deadline for implementing the revised Schedule M expires, warned Ram Babu, president of the state Indian Drug Manufacturers' Association (IDMA).
The stringent and costly requirements for upgrading to the revised Schedule M are proving to be an insurmountable challenge for many small-scale units.
In response to this looming crisis, the IDMA is organizing training programs to support all industries, including its own members, in their efforts to comply with Schedule M. Babu noted that despite over 600 small-scale manufacturing units operating in Telangana, none of them are direct members of the IDMA. However, industries falling under the MSME (micro, small, and medium enterprises) sector are part of the association, with approximately 100 manufacturing units currently holding membership in Telangana IDMA.
Babu emphasized that if the central government does not grant an extension of another year, a majority of these small-scale units will be forced to cease operations. He highlighted the prohibitive costs associated with escalating to the revised schedule, which many units simply cannot afford. When asked about the number of industries that have already submitted Form A, expressing their intent to implement the new Good Manufacturing Practices (GMP), Babu stated that while the association does not have the exact data, the drug controller has informed him that about 70 per cent of the medium-level units have assured the CDSCO of their decision to continue.
To better understand the challenges faced by small-scale units, Babu indicated that IDMA would establish internal committees. These committees will focus on identifying the specific problems encountered by these manufacturers and assessing their willingness to continue operations by upgrading their facilities. The association pledges to provide maximum support to those units committed to compliance.
However, Babu reiterated his concern that a significant number of small units would inevitably cease operations if the government does not grant an extension to the current deadline. "Right now nobody knows how many of them have made their commitment to continue. They are not members of our association, but we want to help them for their survival,” he said.
Meanwhile, a crucial meeting is scheduled for August 8 in New Delhi, where all Indian pharmaceutical industry associations will meet with the Drugs Controller General of India (DCGI), Dr. Reghuvanshi.
J Raja Mouli, an industry leader and former president of the Telangana IDMA, expressed optimism that this interactive session will lead to the associations formally requesting an additional year for the implementation of Schedule M. He voiced hope that the government would recognize the practical difficulties faced by MSMEs across the country and provide the necessary extension to enable them to bring their production facilities up to international standards.
Harish K Jain, the president of the Federation of Pharma Entrepreneurs Forum (FOPE) confirmed that the DCGI has extended an invitation to both FOPE and the Confederation of Indian Pharmaceutical Industry (CIPI) for the interactive meeting scheduled on August 8 in New Delhi. He stated that the feedback gathered from their association members would be presented at this session. While personally not inclined to seek an extension of the deadline, he acknowledged that if the majority of the members wished for it, he would put forth the request.
Meanwhile, J. Jayaseelan, chairman of the Tamil Nadu branch of the IDMA, clarified that the IDMA would engage in a separate meeting with the central drug controller to apprise of the industry's concerns. He emphasized that the IDMA regularly holds discussions with the DCGI on industry matters, and therefore, they would not be attending the broader August 8 meeting with other associations.
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