India mulls annual audit of raw material suppliers by drugmakers

Subject: Schemes

Section: Health

Context:

India is considering making it mandatory for drugmakers to audit their raw material suppliers, at least once a year.

What is the need for mandatory auditing?

Recently the World Health Organisation has flagged cough syrups made in India to death of several children in The Gambia and Uzbekistan.

Proposed guidelines by the CDSCO:

The idea was mooted by the Central Drugs Standard Control Organisation (CDSCO) at a meeting on revised Schedule M (GMP).
The proposed annual audit 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 licensing authority (LA).
The supplier’s audit will cover raw material and packaging material.
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.
Under the proposed provision on product recall, the drugmakers will have to inform the LA and comply with a comprehensive system specified for prompt and effective recall.

Schedule M of Good manufacturing Practices (GMP):

Schedule M guides on Good Manufacturing Practices regarding company premises, quality control system, quality check laboratories, production, cleaning of equipment, housekeeping, cross-contamination, and other related topics.
Schedule M-I: Deals with the requirements of factory premises for manufacturing of Homeopathic preparations.
Schedule M-II: Deals with the requirements of premises, plant, and equipment for manufacture of cosmetics.
Schedule M-III: Deals with the requirements of premises, plant, and equipment for manufacture of Medical devices.

About WHO- Good Manufacturing Practice (GMP):

Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Complying with GMP will help avoid mix-ups, contamination, cross contamination, errors while ensuring quality of drugs, patient safety and building trust and confidence.