NEW DELHI: The Central government has notified the Revised Schedule M guidelines, under which pharmaceutical companies must inform the licensing authority about recalling a drug and report product defects, deterioration or faulty making.
So far, there has been no provision for informing the licensing authority about drug recalls. Schedule M, part of the Drugs and Cosmetics Act 1940, deals with Good Manufacturing Practices to be followed by pharmaceutical manufacturing units in the country.
The new guidelines state that the manufacturer must be responsible for the quality of the products so that “they are fit for their intended use, comply with the license requirements, and do not place patients at risk due to inadequate safety, quality, or efficacy.”
These guidelines come against the backdrop of multiple complaints of sub-standard Indian drugs and deaths abroad, reportedly due to them since 2022. Welcoming the move, Sudarshan Jain, Secretary-General of the Indian Pharmaceutical Alliance, said, “The revision of Schedule M by the government is a positive step and an important milestone for the Indian pharmaceutical sector.”
“This will elevate and update the quality standards of medicines, reinforcing the reputation of our industry and improving patient outcomes. We welcome this initiative propelling India’s journey to becoming a global benchmark in quality,” Jain said.
He also said that the revised regulations of Schedule M will help ensure compliance with international quality standards and benefit both patients and the industry by promoting the manufacturing of safe, effective, and high-quality drugs. “The focus on risk management, qualification, and validation of equipment, and self-inspection will be a vital contribution,” he added.
The amended guidelines stress the need for stable testing of drug substances under recommended climate conditions to upgrade MSMEs at par with global standards, especially those of the WHO.
Good practices