India is considering making it mandatory for drugmakers to audit their raw material suppliers, atleast once a year.
Mooted by Central Drugs Standard Control Organisation at a meeting of drugmakers earlier this month on revised Schedule M (GMP), the proposal comes in the backdrop of World Health Organisation, beginning October 2022, flagging cough syrups made in India to death of several children in The Gambia and Uzbekistan.
In a presentation at the meeting, the regulator said the annual audit proposed will replace the existing self inspection, quality audits and supplier audits whose frequency is routine and on specific occasions such as product recall or inspection by the licencing authority (LA). The suppliers audit will cover raw material and packaging material.
Pointing out “all countries are looking at India for medicines” and compliance to good manufacturing practices (GMP) is mandatory, the regulator listed excipient compatibility and stability studies, quality culture at all levels, data integrity as well as multi product manufacturing facilities and loan licensing among the concerns and challenges.
Complying with GMP will help avoid mix-ups, contamination, cross contamination, errors while ensuring quality of drugs, patient safety and building trust and confidence, according to the presentation. Another key change proposed pertains to compliance and adverse reactions. As opposed to the existing practice of reporting to the LA only in the event of serious adverse drug reactions, the drugmakers would be required to report to the Authority faulty manufacture, product deterioration, serious quality problems. Under the proposed provision on product recall, the drugmakers will have inform the LA and comply with a comprehensive system specified for prompt and effective recall.
Though representatives of some drugmaker bodies are said to have expressed reservations in terms of the feasibility to conduct annual audit of raw material suppliers, the government is expected to shortly issue a notification or guidelines on the changes, sources said.
Published - September 21, 2023 06:30 am IST
