01-05-2025
Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
Small and Medium Pharma Manufacturers Association told News18 that firms lack financial resources to upgrade their facilities and government should give them 2-3 years instead of 1
Despite being granted the extension that small and medium drugmakers had asked for, most pharmaceutical companies have still not applied to delay compliance with Schedule M or revised drug manufacturing rules, News18 has learnt.
The central government has shown concern over the trend and asked firms to act quickly.
Quality concerns
Following allegations levelled over the quality of made-in-India drugs by multiple countries, including the World Health Organization, in 2023, the central government updated the Good Manufacturing Practices (GMP) under Schedule M of the Drugs Rules, 1945.
Many micro, small, and medium-sized (MSME) drug companies — those with a turnover of less than Rs 250 crore — asked for more time to meet these new standards, as the move requires both investment and time.
Considering the industry's request, the government issued a new order in February 2025, allowing eligible companies to apply for an extension until December 31, 2025. To get this extension, companies had to submit an application and a plan for upgrading their facilities within three months.
However, according to the letter seen by News18, Punya Salila Srivastava, secretary at the union ministry of health and family welfare, despite this support and multiple reminders—including official letters and a review meeting at the Central Drugs Standard Control Organisation (CDSCO)—very few companies have applied.
' … as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the letter, dated April 30.
Srivastava, who has sent the letter to the health secretaries, special chief secretaries, and principal secretaries of all states and union territories, has now asked state drug regulators and industry associations to take this matter seriously.
'It is requested to issue necessary directions to the state drug regulators and pharmaceutical manufacturers in your state/UT to take up the issue on priority … within the stipulated time and submit the application for extension on the ONDLS portal," the letter said.
The union health secretary has highlighted that compliance with revised drug laws is 'critical" for the quality and safety of medicines manufactured in India.
'By taking necessary action together, I am sure we can ensure safety, quality and efficacy of drugs. To this effect, compliance with the necessary provisions of the Revised Good Manufacturing Practices (GMP) under Schedule-M is critical," she said in the letter.
Handholding, financial support and more time needed: Pharma association
Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association, told News18, 'Small and medium pharmaceutical companies lack the financial resources to upgrade their facilities to meet the new standards. Rather than pushing us out of business in the name of aligning with global norms, the government should support and guide us through training and assistance to help us meet these standards. We request that the government reconsider the decision to extend the deadline to two to three years, along with extending financial support to the industry."
He referred to the letter written by his association in January, which urged the health ministry for a 'condition-free" timeframe of two to three years for implementing Schedule M.
Similarly, RSS affiliate Laghu Udyog Bharati (LUB) told News18 that the demand for an extension of the deadline was extended when their lobby requested the union health minister JP Nadda. 'On the request of Laghu Udyog Bharati, Hon'ble Health Minister JP Nadda extended the implementation of Revised schedule M guidelines up to 31st Dec 2025 for below 250 crore turnover MSME companies," said LUB in a statement.
However, Ghanshyam Ojha, all-India president of LUB, said, 'We demanded a blanket extension as every small company has to invest Rs 4 crore to Rs 10 crore in plant upgradation for Revised Schedule M certifications."
Ojha mentioned how drugmakers are struggling with the 'gap analysis of every plant" and facing technical difficulties in several steps. 'Small and medium enterprises are in panic and are trying hard to comply with new norms," he said while adding that the drugmakers will request the union health ministry to consider their request to give the industry more time.
According to government data, there are around 10,500 manufacturing units in the country, of which at least 8,500 are in the category of micro, small, and medium enterprises (MSME). Of these, 2,000 are approved by the World Health Organization certified as WHO-GMP (Good Manufacturing Practices).
tags :
drug manufacturing medicine
Location :
New Delhi, India, India
First Published:
May 01, 2025, 17:58 IST
News india Few Pharma Firms Apply For Schedule M Extension After Seeking More Time; Govt Urges Urgent Action
