Small and micro-level pharmaceutical units in Telangana are on the brink of closure as the deadline to implement the revised Schedule M approaches, warned Ram Babu, president of the Telangana chapter of the Indian Drug Manufacturers’ Association (IDMA). The updated Good Manufacturing Practices (GMP) mandate significant financial and infrastructure upgrades—an overwhelming burden for many small-scale units.

While over 600 small-scale manufacturers operate in the state, none are direct IDMA members. Around 100 units from the MSME sector are part of the Telangana IDMA. To support them, the association is conducting training programmes to help units transition toward compliance.

Babu stated that without a one-year extension from the Centre, most units would be forced to shut shop due to prohibitive upgrade costs. Though exact data is unavailable, the state drug controller informed IDMA that about 70% of medium-scale firms have expressed willingness to comply by submitting Form A to CDSCO.

To address sector-specific challenges, IDMA plans to form internal committees to assess unit readiness and provide tailored support. However, Babu remained firm that without an extension, closures are inevitable.

An important meeting with DCGI Dr. Rajeev Singh Raghuvanshi is scheduled for August 8 in New Delhi, where key pharma associations—including FOPE and CIPI—will present MSME concerns and may seek a formal extension.

J Raja Mouli, former Telangana IDMA president, voiced hope that collective industry feedback would help secure a deadline extension. FOPE president Harish K Jain confirmed participation and said he would support an extension if his members demand it, despite his personal reservations.

Meanwhile, J. Jayaseelan, chairman of Tamil Nadu IDMA, said their state unit would meet the DCGI separately, continuing regular consultations to communicate industry-wide issues.

With financial constraints and regulatory pressures mounting, the next few weeks may prove decisive for Telangana’s small-scale pharma manufacturers.