Context

In response to global concerns regarding sub-standard medicines exported from India, the Ministry of Health and Family Welfare recently announced revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.

Aim: The aim is to bolster the commitment of the pharmaceutical sector to produce safe, effective, and high-quality drugs in accordance with international standards, benefiting both patients and the industry.

Background

• India faced international scrutiny last year following the World Health Organization's (WHO) alert about contaminated cough syrups.
• The substances found, diethylene glycol and ethylene glycol, are toxic and potentially fatal.
• The contamination was traced to a batch manufactured by QP Pharmachem Ltd in Punjab, leading to the suspension of their license.
• This incident highlighted the need for stringent measures to ensure the quality of pharmaceutical products.

The Revision:

• The revision responds to the evolving pharmaceutical manufacturing landscape and increased understanding of the interdependence between manufacturing and product quality.
• The Ministry acknowledges the necessity to reevaluate the existing Good Manufacturing Practices (GMP) regulations to align them with global standards, especially those outlined by the WHO.
• This move aims to ensure the production of high-quality drugs that meet global acceptability criteria.
• The revised rules introduce five new categories of drugs, covering substances such as sex hormones, steroids, cytotoxic substances, biological products, and radiopharmaceuticals.
• Additional sections include the implementation of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerized storage system for all drug products.
• According to the notification, manufacturers must take responsibility for the quality of pharmaceutical products, ensuring they meet licensing requirements and do not pose risks to patients due to safety, quality, or efficacy issues.
• Companies are required to market finished products only after obtaining satisfactory results from ingredient tests and retaining samples for further verification.

Implementation and Timeline:

• The Ministry has set a deadline for compliance based on company turnovers.
• Small manufacturers (annual turnover less than Rs 250 crore) have 12 months to adhere to the revised rules, while large manufacturers (annual turnover over Rs 250 crore) must comply within six months.
• The revised Schedule M, with 13 parts providing GMP guidelines, signifies a significant step towards enhancing the quality of pharmaceutical drugs in India.
• By aligning with global standards, the Ministry aims to rebuild confidence in the Indian pharmaceutical sector and ensure the production of medicines that meet the highest quality benchmarks, ultimately benefiting patients and fostering the industry's reputation worldwide.