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LUB raises various concerns and demands related to pharma industry
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Our Bureau, New Delhi
July 19 , 2025
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Laghu Udyog Bharati (LUB), the association representing micro and small industries in the country, has said that it is pursuing various matters related to the micro, small and medium enterprises (MSME) in pharma sector with the Union health ministry and the ministry of chemicals and fertilisers.
The leaders of LUB, including All India president Ghanshyam Ojha, All India general secretary Omprakash Gupta, All India Head of LUB's Pharma Wing Dr Rajesh Gupta, Maharashtra pharma wing head Dr Ravleen khurana, Madhya Pradesh pharma wing Head Amit Chawla, along with other industry representatives have met the Union minister of chemicals and fertilisers and health and welfare, J P Nadda and raised various demands of the industry, it said.
The leaders raised concerns regarding the extension of deadline for implementation of revised Schedule M, which is critical for the survival of the MSME pharma companies below Rs. 50 crore turnover. An extension of deadline would prevent closure of large number of micro and small companies.
The organisation also reiterated that the current policy of the drug regulator to publish the Not of Standard Quality (NSQ) drug samples every month is having a negative impact on the Brand Bharat, especially in the African markets.
While almost 97.3% of the products getting passed in the quality test is not highlighted, the 2.64% NSQs are getting attention. The risk-based inspections in the units are also resulting in closure of manufacturing facilities in the country.
On the other hand, the drug recalls from US Food and Drug Administration is also impacting the Brand Bharat, it added.
The LUB has also requested the Ministry to appoint a representative of the organisation in the Drugs Technical Advisory Board (DTAB). It has also requested the government to form a Drug Tribunal Board following Section 33P guidelines and the Jan Vishwas Bill, for speedy disposal of pending litigations.
The meeting also had a discussion at length on the hurdles in export No Objection Certificate (NOC) for the pharma sector, to support exports to almost 183 countries. It sought the Ministry that the implementation of New Drugs and Clinical Trials Rules, 2019 should not be retrospective, and the approvals for sustained-release formulations manufactured before 2019 should be safeguarded.
There is also a need for guidance on active pharmaceutical ingredients, excipients, and solvents industry for import and domestic manufacturing. The organisation also raised complaint that the financial support from the government under the production linked incentive schemes for the sector is still pending for disbursement, even though the investments has been made already.
The Organisation aid that further meetings will be held with the relevant ministries to follow up on the matter and the Minister has assured that there would be resolution to the issues in the near future.
"The meetings have been a positive step towards addressing the concerns of MSME pharma industries, while the Minister Nadda showing understanding and cooperation..." said the LUB leaders. The president and general secretary of the organisations were also invited to join various meetings as special invitees in New Delhi.
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