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 Expressing the grievances of the small and micro pharmaceutical industries, the Laghu Udyog Bharati (LUB), an association of small and micro enterprises (SME) headquartered in New Delhi, has urged the Union health minister to consider a further extension of the deadline, upto 2026 end, for implementing the revised Schedule M in pharmaceutical companies with a turnover below Rs. 50 crore.
Making this demand to the government, LUB has sent one letter, signed by its national president Ghan Shyam Ojha and general secretary Om Praksh Gupta, to Union health minister JP Nadda.
In the letter, the association says that there are about 4,000 micro and small pharma enterprises in India, and the association conducted a discussion with all the units and feedback was taken before forwarding this request to the health minister. They said, all the SME manufacturers are requesting for the minister’s attention and handholding for extension of the deadline upto December 2026.
Additionally, the industry body has wanted the health minister for all his support to the pharma SMEs to comply with the new Schedule M for the growth of the industries. LUB wants the MSME industry under the control of the minister to be developed, and made them capable of meeting the prime minister's initiative, ‘Brand Bharat’. The leaders of the association said many of the SME pharma enterprises are more than 30 years old, and they played a significant role in the supply of pharmaceuticals during the Covid-19 period to the needy masses, so that India’s claim as ‘Pharmacy of the World’ was reinforced worldwide.
In February this year, the health ministry had extended the deadline for implementation of the new GMP standards in manufacturing units with turnover less than Rs. 250 crore upto 31.12.2025. LUB wants this deadline to be extended to one more year.
The leaders of the association said, the government should consider putting a stop to the Risk-Based Inspections (RBI) in the industries till the deadline is over, except on critical issues. The RBIs can be revived after the implementation of the new Schedule M.
They alleged that the regulators’ behaviour during the inspections was not industry-friendly, but conducted the inspection in the form of a raid, and news was given to the media depicting the industry people as culprits. The leaders of the LUB said in their letter that the manufacturers are law abiding citizens and engaged in the business as part of the ‘Make in India’ and ‘Ease of Doing Business’ programmes.
They reminded the minister about the formation of the Indian Drug Advisory Forum (IDAF) under the leadership of the Drug Controller General of India in March, 2018, but very few meetings, that too only online, were held during and after the Covid period. Now the Forum is inactive or in a state of dormant condition, so the minister should direct the present DCGI to convene the meeting occasionally to hold interactions among the industry stakeholders and the regulators in order to discuss and resolve the issues faced by the pharmaceutical manufacturing companies in the country.
The association apprised the minister that several notable things could be achieved through IDAF meetings for the industries, mainly the extension of WHO-GMP Licence validity from two years to three years. Similarly, the QR code on active pharmaceutical ingredients is also one achievement.
The minister has been urged to include members from the Laghu Udyog Bharati, which has a membership strength of 55,000 industrial units and a Pan-India presence of 581 districts, as members into the Drug Technical Advisory Board (DTAB). LUB alleges that, currently, the DTAB comprises members from only MNCs/large pharmaceutical companies, and the decisions pertaining to the pharma industry are taken without the majority industries concurrence. The majority of the pharma industries come under the MSME sector. Actually, this kind of decision-making is unfriendly and unsuitable to small-scale sector industries, the office-bearers feel.
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