Sulfamethoxazole/Trimethoprim

New Delhi: Amid rising concerns over the growing incidence of substandard drugs produced by MSME units in India, small drugmakers have argued that unsustainable price caps and insufficient financial support are undermining their ability to maintain quality and address other compliance issues. At a high-level meeting with NITI Aayog—attended by Dr. V.K. Paul, the Drug Controller General of India (DCGI), and other key officials— CIPI Chairman RK Jain concerned that the pricing regulations imposed by the National Pharmaceutical Pricing Authority (NPPA) have severely affected the margins of small manufacturers and has pushed many quality drugs out of the domestic market. “Unsustainable pricing has pushed many quality drugs out of the domestic market,” he said. The representative also urged the government to provide financial assistance to help MSME pharmaceutical firms build infrastructure for stability studies and reduce the incidence of Not of Standard Quality (NSQ) drugs. Citing the example of co-trimoxazole, he highlighted that the ceiling price set by the National Pharmaceutical Pricing Authority (NPPA) has compelled small manufacturers to discontinue its production. Co-trimoxazole, an antibiotic indicated to treat bacterial infections was added to the national list of essential medicines (NLEM) in 2022, that resulted in the average reduction of around 16 per cent. Currently, the ceiling price for co-trimoxazole oral liquid (5 ml suspension) is capped at ₹0.35 per ml, while the tablet form is priced at ₹0.9 and ₹2.3 for higher dosage strength. Under Schedule I of the Drug Price Control Order (DPCO), 2013, the NPPA regulates both bulk drugs and formulations listed in the NLEM by fixing ceiling and retail prices to ensure affordability. Marketers are allowed to raise prices in line with inflation, based on the Price Differential Index prepared by the Office of the Economic Adviser (OEA), Ministry of Commerce and Industry. Meanwhile, over the dealy in compliance with the revised schedule M norms, representatives from other lobby groups such as Laghu Udyog Bharati, FOPE, IDMA and several others presented that, “gap analysis and detailed data requirements create hindrances in filing for entitlement for many companies, as many changes occur during development.” “MSME below ₹50 crores needed hand-holding and further extension in Revised Schedule M, as well as simplification of DOP-derived RPTUAS as per Revised Schedule M or WHO Good Manufacturing Practices (GMP),” the representatives noted. The PTUAS (Pharmaceutical Technology Upgradation Assistance Scheme) is a credit-linked initiative offering up to ₹1 crore in financial aid for MSME pharma units aiming to upgrade their facilities to WHO-GMP or Schedule M standards. Besides this, the industry representatives has also called for incentivising the compliance process by offering rewarding with ₹50 lakhs to ₹2 crores to companies that successfully obtain license through joint inspections of CDSCO and state regulatory bodies. Small drugmakers are those entities who have an annual turnover of or less than ₹250 crore and of the country’s total poll of 10,500 manufacturers around 8,500 fall under the MSME category. However, according to the Ministry of Health, only 2,000 of these units are WHO-GMP certified—highlighting the urgent need for targeted policy support, infrastructure upgradation, and regulatory collaboration to ensure quality manufacturing at scale. By Abhijeet Singh ,