(MENAFN- Live Mint) New Delhi: The Centre plans to extend the deadline for complying with good manufacturing practice (GMP), at par with the World health Organization (WHO) standards, for small Pharmaceutical companies with a revenue of ₹250 crore or less less by one year till 31 December 2025.
The regulation will come into force from 1 January 2026.
The earlier deadline expired on 1 January 2025.
This comes in the backdrop of several respresentations sumbitted to the government by various associations requesting extension of the timeline to enable micro, small and medium pharma companies to comply with the provisions of the revised Schedule M.
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Good Manufacturing Practices (GMP) are being implemented in the country to bring quality into products by way of control on materials, methods, machines, processes, personnel and facility or environment.
The government notified new Schedule M was in December 2023. In order to have smooth transition from the present Schedule M to revised schedule M, it was decided to provide a transition period of 6 months and 12 months for large manufacturers (more than Rs.250 cr revenur) and MSME (less than Rs.250 cr) respectively.
Stakeholder comments awaited
“We are looking forward to receving the comments from the industry stakeholders within 7 days following which Drugs Technical Advisory Board shall held a meeting as per the provisions, to amend the previous notification of December 2023,” said an official aware of the matter.
“It should be done by the next within 15 January or so. These firms actually requesting for extension for 2 years. However, the government has considered the extend the timeline only by one year. The main reseason they have highlighted is arranging for finances for upgradation of the plant,” the official added.
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India is a major exporter of medicines to developing countries, which requires WHO GMP certification.
At present there are only around 2,000 units in MSME category in the country with WHO GMP certification. There are around 10,500 drug manufacturing units in India, of which around 8,500 fall under the MSME category.
Creating awareness
Meanwhile, the Central Drugs Standard Control Organization (CDSCO), in collaboration with States/UTs, has conducted nationwide plan for stakeholders to make them aware about the new Schedule M including its requirements, importance and technical justification, resource availability etc.
So far, CDSCO has inspected more than 800 manufacturing units and 252 public testing labs till now. The inspections show an improvement in implementation of GMP standards by MSMEs.
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Queries sent to the health ministry spokesperson remained unanswered till pess time.
“We welcome this step from government which is in positive direction and in national interest. We are committed to upgrade our facilities and systems to global standards. Government has always been facilitator of growth of Pharma industry. We will ensure that India will also be Pharma Innovation hub of the world,” said Harish Jain, President, Federation of Pharmaceuticals Entrepreneurs (FOPE).
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