The Wire Staff 
New Delhi: Rashtriya Swayamsevak Sangh (RSS) affiliate Laghu Udyog Bharati (LUB) has urged the Union government to adopt a more considerate approach when inspecting micro and small pharmaceutical companies.
LUB has expressed concerns about potential medicine shortages in the coming months due to an atmosphere of “apprehension” caused by ongoing inspections and notifications of closures or production halts, News18 reported.
The body is a registered national-level organisation, working for the cause of micro, small and medium enterprises in over 400 districts.
This is the second letter from LUB on this issue. The previous one, sent in July, was retracted, saying it was sent due to some “confusion”.
In their latest letter titled ‘Urgent Action Required to Preserve the MSME Pharma Industry,’ LUB has requested the government to avoid “minor lapses”.
This letter was sent to Union health minister Mansukh Mandaviya on October 5.
It also argues for a “minimum three-year period” for the industry to adapt to Schedule M, calling the government’s deadline of six months to one year “impractical”.
The Ministry of Health and Family Welfare, through its drug regulatory arm, the Central Drugs Standard Control Organisation (CDSCO), has been conducting risk-based inspections at select companies following concerns raised by the World Health Organization and several other countries regarding the quality of Indian medicines.
‘Inspections resembling raids’
The letter, also marked to the health secretary and Drug Controller General of India, emphasises “patient safety and health over minor documentation discrepancies”, the report added.
“While we wholeheartedly support risk-based inspections initiative, we have observed that, in the last 30 days, several MSME units were inspected in a manner resembling a raid,” Ghan Shyam Ojha, all-India president of LBU, wrote in the letter.
Ojha, in the letter accessed by News18, said: “We advocate for a more considered approach to inspections, especially for small shortfalls (sic)”.
During the inspections, the Union government shut down the units and production lines when not found complying with good manufacturing practices. However, LBU demands a change in its stance.
Concluding the letter, LBU warned, “…shortages of medicines may be observed in the coming months which poses a threat to humanity, as our manufacturers are in deep dilemma and it has created fear factor among all of us.”
It has requested an appointment with the minister to discuss the issue further.
While confirming the dispatch of the four-page-long letter, Ojha told News18 over a call that LBU is awaiting the government’s response. “We expect a favourable response considering the future of the Indian pharma industry which has flourished on its strong foundation of MSME.”
‘Upgrading 8,000 units to Schedule M within one year is impractical’
In August, the health ministry announced that pharmaceutical companies with an annual turnover exceeding Rs 250 crore must adhere to Schedule M standards, which are equivalent to WHO-GMP certification, within six months.
Companies with a turnover less than Rs 250 crore were given one year to comply.
However, LUB has emphasised in the letter that the industry requires a minimum of three years to implement these changes.
It argues that the 2018 draft rule should not be enforced hastily, as it took 77 years to reach this point, and upgrading 8,000 units to Schedule M within one year is impractical.
The letter points out that the pharmaceutical industry is already subject to numerous regulations, including those related to narcotics, labour, pollution (both at the central and state levels), and industries.
LUB asserts that if each regulatory body were to initiate risk-based inspections, it would be unmanageable for the industry.
‘Adopt a holistic approach’
LUB cited an example of a US-based pharmaceutical company, Abbott (without explicitly naming it), to illustrate that even large corporates with top-tier approvals frequently fail to meet quality standards.
LUB highlighted that companies with USFDA, EU-GMP, and WHO-GMP certifications have experienced quality lapses, resulting in recalls of their products in both global and Indian markets. LUB has called upon the government to adopt a holistic approach in addressing the issue of “Not of Standard Quality (NSQ)” rather than exclusively targeting the pharmaceutical formulation industry.
They argue that NSQ determinations are influenced by various factors, including transportation issues, quality assessments, laboratory efficiency, storage conditions, and more.