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CDSCO Flags Alarming Spike in Substandard Drugs from MSME Pharma Firms

As part of its ongoing nationwide surveillance, the CDSCO routinely collects drug samples from retail outlets, hospitals, and distributors, which are then tested at government-run laboratories. In April alone, 60 drug samples were found to be Not of Standard Quality (NSQ), indicating a serious breach of regulatory standards.

• By Newsdesk
• New Delhi
• Jun 19, 2025

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A concerning number of micro, small, and medium-sized pharmaceutical companies in India are producing substandard medicines, according to fresh data released by the Central Drugs Standard Control Organisation (CDSCO). The latest figures for April reveal that many of these MSME manufacturers are consistently failing to meet basic quality benchmarks, raising red flags about the safety of medications being supplied across the country.

As part of its ongoing nationwide surveillance, the CDSCO routinely collects drug samples from retail outlets, hospitals, and distributors, which are then tested at government-run laboratories. In April alone, 60 drug samples were found to be Not of Standard Quality (NSQ), indicating a serious breach of regulatory standards.

Among the failed products were commonly used formulations including carboxymethylcellulose sodium eye drops (artificial tears), bupivacaine hydrochloride injection (a local anaesthetic), and calcium carbonate with vitamin D3 tablets. These were traced back to lesser-known MSME firms such as Gidsha Pharmaceuticals (Gujarat), Martin and Brown Biosciences (Himachal Pradesh), Sai Parenterals (Hyderabad), and Nestor Pharmaceuticals (Faridabad). Attempts to contact these companies for comment were unsuccessful.

"This is not an isolated issue — it's part of a larger, ongoing trend," said a senior official familiar with the regulatory oversight. “A significant portion of MSME drug manufacturers have been routinely flagged for quality violations, prompting the health ministry to introduce stricter manufacturing standards under revised guidelines.”

The data echoes earlier findings from 2023, when a nationwide risk-based inspection (RBI) campaign revealed that over 65% of MSME pharma companies were producing drugs that failed quality checks. Approximately 30% of these companies were issued stop production orders (SPOs) after failing compliance audits, with 68% of their product samples testing below acceptable standards.

This surge in regulatory scrutiny follows global concerns about the quality of Indian-made medicines, particularly after reports emerged linking contaminated cough syrups to the deaths of children in The Gambia last year. In response, the CDSCO and state-level drug inspectors launched a widespread crackdown to root out spurious and substandard pharmaceuticals.

Investigators have attributed many of these failures to deficiencies in infrastructure, inadequate quality control systems, and gaps in manufacturing process knowledge. “There is a strong link between poor-quality drugs and the overall condition of the production facilities,” an official noted. “Some companies repeatedly fail with the same product across multiple inspections, suggesting systemic issues.”

The recurring lapses have also renewed calls to urgently revamp India’s Good Manufacturing Practices (GMP) regulations and enforce stricter Quality Management Systems (QMS) across the industry — especially within the MSME sector, which forms the backbone of India’s pharmaceutical manufacturing base but often lacks the resources and oversight of larger players.

As the government tightens the regulatory net, the pressure is mounting on small and medium drugmakers to invest in upgrading their operations or risk being pushed out of an increasingly quality-conscious market.

(With inputs from The Economic Times)