|
 Laghu Udyog Bharati (LUB), the voluntary network and welfare organisation of micro, small and medium enterprises (MSME) with over 66,400 industry members, has requested the Central drugs regulator to highlight that 97% of the medicines available in the country are of standard quality, while the industry would work towards further reducing the presence of Not of Standard Quality (NSQ) drugs in the market.
The organisation, in a submission to the Central Drugs Standard Control Organisation (CDSCO), referred to the data presented by the minister of state for the ministry of health and family welfare Anupriya Patel in Rajya Sabha in March, this year. The Minister informed the upper house of the Parliament that out of the total samples of 4,92,904 tested in five years, almost 14,342 (2.91%) were NSQs and 1,593 (0.32%) were spurious or adulterated.
LUB said that 2.5-3% NSQ cases should not overshadow the 97% standard quality drugs available in the market, and requested the drugs regulator to publish the list of 97% Standard Quality compliant companies also.
The reasons for drugs becoming NSQ are multi-factorial and not always manufacturing failure. The factors that could impact the quality standard of the drugs include storage and distribution failure beyond the control of the manufacturer, temperature excursion during transit - especially in summer season, lab to lab variation or analytical method variation, and post-manufacturing degradation at retail or warehouse level.
"Therefore, 97% standard quality medicines manufactured by thousands of MSME pharma units serving the nation and PM Jan Aushadhi should not be penalized or defamed for 2.91% NSQ cases," said Rajesh Gupta, All India Head of the Pharma Wing at LUB.
The organisation requested the central drugs regulator to differentiate between intentional spurious of 0.32% from the unintentional NSQ of 2.91%, and "publish the list of 97% Standard Quality compliant companies also, to motivate good quality manufacturers and to protect the industry from media trial". This would help to build confidence amongst patients that Indian medicines are fully safe and effective, it added.
"Simultaneously, industry is ready to work on reducing this 2.91% NSQ percentage. We offer to adopt in-vitro analysis procedures and work under your guidance to further reduce this percentage esp sample drawn & testing procedures also needs your attention," said the organisation. "We seek scientific handholding and support for MSMEs through standard quality data publications".
Patel, earlier this month, has informed Lok Sabha that during the year 2025-26, out of the total 1,41,322 drug samples tested during the year 2025-26, a total of 283 drug samples (0.20%) was declared as spurious or adulterated, while 3,012 samples (2.13%) were declared as NSQs.
|