Business

New Pharma Rules in India Take Effect: Challenges Ahead for MSMEs

The revised Schedule M introduces stringent norms covering premises, plant equipment, and manufacturing practices. Key updates include requirements for annual product quality reviews, quality risk management, and a robust pharmaceutical quality system.

• By Newsdesk
• New Delhi
• Jan 02, 2025

Business

India’s pharmaceutical industry enters a new era today, January 1, as the updated Schedule M regulations officially come into force. These changes, aimed at enhancing manufacturing standards, mandate compliance from drug manufacturers across the country, signaling a pivotal shift for the sector.

Despite appeals from industry stakeholders for a deadline extension, the government has made it clear that non-compliance will lead to strict actions. 

The revised Schedule M introduces stringent norms covering premises, plant equipment, and manufacturing practices. Key updates include requirements for annual product quality reviews, quality risk management, and a robust pharmaceutical quality system. Additionally, the government now has the authority to conduct audits and risk-based inspections to ensure adherence.

Industry Concerns and MSME Challenges

In 2024, pharmaceutical leaders lobbied the health ministry for more time to adapt, citing challenges such as delays in acquiring machinery and upgrading infrastructure. Micro, Small, and Medium Enterprises (MSMEs), in particular, have expressed concerns about their ability to meet the new standards without additional time.

“Upgrading infrastructure and procuring equipment is a time-intensive process,” said Rajesh Gupta, National Pharma Head at Laghu Udyog Bharati (LUB) and President of the Himachal Drug Manufacturers Association. “We support the government’s initiative and are conducting awareness seminars, but the MSME sector needs until December 2026 to comply fully.”

Gupta highlighted issues such as loan approvals and supply chain delays, which have hampered efforts to meet the updated standards.

Push for an Extension

Organizations like LUB, an affiliate of the Rashtriya Swayamsevak Sangh (RSS), and the Federation of Pharma Entrepreneurs (FOPE) have been at the forefront of advocating for leniency. They have appealed to Health Minister JP Nadda, emphasizing the need for a phased implementation to safeguard the survival of smaller pharmaceutical players.

The revised Schedule M, part of the Drugs and Cosmetics Rules, 1945, was notified by the Ministry of Health in January 2024. It builds on Good Manufacturing Practices (GMP) standards, which also include protocols for swiftly recalling defective products.

As the new rules take effect, the spotlight remains on MSMEs and their ability to adapt while ensuring quality and safety in pharmaceutical production. Industry observers anticipate this regulatory overhaul will eventually strengthen the sector, but its immediate impact on smaller players remains a pressing concern.