By: IPP Bureau
Last updated : September 26, 2025 7:39 pm
The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.
The Drug Marketing and Manufacturing Association (DMMA) has warned that the growing regulatory burden could force widespread closure of small and medium-sized pharmaceutical units in Gujarat and sought urgent government intervention to safeguard the industry. The association has warned that the shutdown of units would have a huge impact on pharma exports and trigger job losses.
Over 30 pharma associations (DMMA, Federation of Pharma Entrepreneurs, Laghu Udyog Bharti, state associations from Himachal (HDMA), Haryana, Karnataka, etc.) have jointly appealed to Union Health Minister JP Nadda and Central Drugs Standard Control Organisation (CDSCO), and submitted a detailed representation outlining the challenges specially withdrawal of the recent directive enforcing bio-equivalence studies under GSR 327 (E).
Each BA/BE study costs Rs. 20–40 lakh per product, and MSMEs may have dozens of formulations. This makes compliance financially unviable, saying the lack of officially notified reference products, the high cost of studies, and ethical concerns make compliance impractical and impossible for small units to absorb. Without urgent relief, thousands of units will collapse, leading to medicine shortages nationwide. The association stressed that constant rule changes and stringent compliance demand threaten to destabilise India's position as the “Pharmacy of the World.”
The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive. The association raised alarm over the Revised Schedule M (Good Manufacturing Practices) requirements, slated to come into effect from January 1, 2026. It warned that the expanded scope and costly upgrades, notified without accommodating the objections of MSME sector, could force 4,000–5,000 units to close. It demanded that the deadline for companies have a turnover of less than Rs. 50 crores should be extended till April 2027.
DMMA objected to risk-based inspections that selectively target MSME units while sparing large corporates, and to the practice of shutting down plants merely based on a manufacturer's own corrective action report if no critical lapses are found.
DMMA President Amit Thakkar said, "Micro, small, and medium enterprises are the backbone of India's pharmaceutical industry, but they are being burdened by an endless stream of regulatory circulars that run counter to the government's own Ease of Doing Business agenda. While MSME manufacturers will be hit the hardest, these measures will also create shortages of affordable medicines and erode our export competitiveness, allowing other countries to overtake India in global markets."
It demanded simplification of the Export NOC process, saying that the current process is delaying shipments and that the country is losing business to competitors such as China, Bangladesh, and Vietnam, even though exports are not governed by the Drugs & Cosmetics Act.
DMMA General Secretary Vikram Chandwani said, "Each of these issues places an enormous strain on companies that have supplied quality, affordable medicines for decades. Without immediate regulatory relief, a large number of MSME pharma manufacturing units will be forced to close. Jobs will vanish, and exports will decline, putting the very future of the Indian pharmaceutical industry at risk."
The association also called for a fairer process for the monthly publication of Not of Standard Quality (NSQ) data, which it says tarnishes reputations without giving companies the chance to respond, and requested that a Standard Quality list be released alongside.
Gujarat, home to Approx. 3000 pharmaceutical manufacturing units, over 90% of which are MSMEs, accounts for a third of India's pharmaceutical turnover and 28% of exports. DMMA said that these units worked tirelessly through crises, including the COVID-19 pandemic, to ensure the supply of medicines.
If relief isn’t given, MSME associations plan 2-day nationwide shutdown / strike of pharma production.
"We are not asking for leniency on quality. We are asking for fair timelines, genuine consultations, and regulations that do not destroy the entire sector," Thakkar added.